search
Back to results

Impact of an Optimised Monitored Anesthesia on the Patients' Recovery After Cytoreduction Surgery Plus HIPEC (CHIPNOL)

Primary Purpose

Hyperthermia, Colorectal Neoplasms, Oxaliplatin

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Remifentanil infusion, desflurane titration and fluid infusion will be guided by NOL index, BIS index and Flotrac EV1000 system respectively
Remifentanil infusion and desflurane titration will be guided by anesthesia usual practices
Sponsored by
Ciusss de L'Est de l'Île de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperthermia focused on measuring Cytoreduction, HIPEC, Oxaliplatin, Colorectal, Peritoneal, Carcinomatosis, Monitoring, Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA status I, II or III
  • Patients older than 18 years
  • HIPEC for bowel surgery with oxaliplatin + dextrose 5% for a duration of 30 min
  • Duration and type of surgery requiring an epidural analgesia via an epidural catheter placed and tunnelled prior the general anesthesia induction and an arterial line placed after induction of general anesthesia.

Exclusion Criteria:

  • Any allergy to one drug used in our anesthesia or HIPEC protocol
  • Any contra-indication or patient's refusal for epidural placement
  • Chronic arrhythmic cardiac conditions
  • Chronic pain with use of opioids more than 3 times per week for 4 weeks
  • Bowel occlusion
  • Physical/mental incapacities
  • Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
  • Epidural failure

Sites / Locations

  • Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Monitored group "M" (optimized controlled anesthesia)

Control group "C" (standard of care anesthesia)

Arm Description

Patients in the Monitored group "M", the NOL index will guide the administration of remifentanil to keep the index between 5-25, and the desflurane will be titrated to keep a BIS index between 45 and 55. Cardiac output and stroke volume variation will be measured by the Flotrac EV1000 system. Patients will receive 250ml fluid challenges with a recommended solution as required, in order to achieve a maximal value of stroke volume.

Patients in the Control group "C" will be managed by clinical staff according to usual practice, desflurane will be administered to keep MAC at 1, and remifentanil infusion rate will be adapted to the mean arterial blood pressure to keep it between 65 and 100.

Outcomes

Primary Outcome Measures

The hospital length of stay in days
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012). After these criteria are achieved, discharge may take place.
Tolerance of oral intake
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Tolerance of oral intake. After these criteria are achieved, discharge may take place.
Recovery of lower gastrointestinal function
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Recovery of lower gastrointestinal function. After these criteria are achieved, discharge may take place.
Adequate pain control with oral analgesia
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Adequate pain control with oral analgesia. After these criteria are achieved, discharge may take place.
Ability to mobilize and self-care
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Ability to mobilize and self-care. After these criteria are achieved, discharge may take place.
Clinical examination and laboratory tests show no evidence of complications or untreated medical problems
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Clinical examination and laboratory tests show no evidence of complications or untreated medical problems. After these criteria are achieved, discharge may take place.

Secondary Outcome Measures

Intraoperative anesthetic gas' consumption in ml/kg/h
Total consumption and absorption of desflurane in ml/kg/h during surgery and for each hour of surgery
Intraoperative remifentanil consumption in mcg/kg/min
Total consumption of i.v. remifentanil during surgery and for each hour of surgery
Intraoperative fluid's consumption in ml/h
Total of fluid perfused during surgery and for each hour of surgery
Intraoperative number of hypotensive events
Total number of hypotensive events during surgery (defined as mean blood pressure below 60)
Intraoperative phenylephrine consumption in mcg/kg/min
Total doses of intraoperative infused i.v. phenylephrine and doses per hour
Intraoperative epidural consumption in 3 ml/h
Total doses of intraoperative Epidural infusion (lidocaine 2%+epinephrine) and doses per hour
Time for awakening in seconds
Time for awakening (eyes opening) at the end of the surgery. Elapsed time in seconds between stopping the gas and opening the eyes of the patient
Time for extubation in seconds
Time for extubation in seconds. Elapsed time in seconds between stopping the gas and patient's extubation
Time for transfert to the PACU in seconds
Time for transfert to the PACU (Post Anesthesia Care Unit) in seconds, after extubatiuon
First NRS pain score (0-10 scale) at times of awakening
NRS (Numeric Rating Scale) Pain Score evaluated at times of awakening, evaluation from 0 (no pain) to 10 (worst imaginable pain) scale
First NRS pain score (0-10 scale) at arrival in PACU
First NRS Pain Score evaluated at arrival in PACU, evaluation from 0 (no pain) to 10 (worst imaginable pain)
NRS pain score (0-10 scale) at rest, in PACU
NRS Pain Score at rest, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
NRS pain score (0-10 scale) with cough, in PACU
NRS Pain Score with cough, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
NRS pain score (0-10 scale) on the Shoulder, in PACU
NRS Pain Score on the Shoulder, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
Hydromorphone consumption (mg) in PACU
Total cumulative dose of titration of intravenous hydromorphone (mg), evaluated every 15 minutes until time for readiness for PACU discharge
PONV score (0-3 scale) in PACU
PONV (PostOperative Nausea and Vomiting) score, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no nausea) to 3 (nausea and vomiting)
POSS score (1-4 scale) in PACU
POSS (Pasero Opioid-induced Sedation Scale) score evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 1 (awake and alert) to 5 (asleep deeply)
Respiratory depression number in PACU
Respiratory depression number evaluated every 15 minutes until time for readiness for PACU discharge
Blood pressure (mmHg) in PACU
Blood pressure (TAS/TAD/TAM) in mmHg evaluated every 15 minutes until time for readiness for PACU discharge
Time for PACU discharge based on Aldrete scores (0-10 scale), in PACU
Time for readiness for PACU discharge based on Aldrete scores (0-10), Aldrete score must be ≥ 9 for PACU discharge
NRS pain score (0-10 scale) at rest, evaluated everyday from 24 hours postoperative to hospital discharge
NRS Pain Score at rest, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
NRS pain score (0-10 scale) with cough, evaluated everyday from 24 hours postoperative to hospital discharge
NRS Pain Score with cough, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
NRS pain score (0-10 scale) on the Shoulder, evaluated everyday from 24 hours postoperative to hospital discharge
NRS Pain Score on the Shoulder, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
Hydromorphone consumption (mg), evaluated everyday from 24 hours postoperative to hospital discharge
Total cumulative dose of titration of intravenous hydromorphone (mg), evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge
Epidural consumption (mg), evaluated everyday from 24 hours postoperative to hospital discharge
Total cumulative dose of titration of epidural (mg), evaluated every day, from 24 hours postoperative until the cessation of the PCEA (Patient Controlled Epidural Analgesia)
PONV score (0-3 scale), evaluated everyday from 24 hours postoperative to hospital discharge
PONV (PostOperative Nausea and Vomiting) score, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no nausea) to 3 (nausea and vomiting)
POSS score (1-4 scale), evaluated everyday from 24 hours postoperative to hospital discharge
POSS (Pasero Opioid-induced Sedation Scale) score evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 1 (awake and alert) to 5 (asleep deeply)
Respiratory depression number, evaluated everyday from 24 hours postoperative to hospital discharge
Respiratory depression number evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge
Blood pressure (mmHg), evaluated everyday from 24 hours postoperative to hospital discharge
Blood pressure (TAS/TAD/TAM) in mmHg evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge
Heart rate (bpm), evaluated everyday from 24 hours postoperative to hospital discharge
Heart rate (HR) in bpm (beats per minute), evaluated every day from 24 hours postoperative until time for readiness for hospital discharge
Oxygen saturation (%), evaluated everyday from 24 hours postoperative to hospital discharge
Oxygen saturation (SPO2) in %, evaluated every day from 24 hours postoperative until time for readiness for hospital discharge
Respiratory rate (bpm), evaluated everyday from 24 hours postoperative to hospital discharge
Respiratory rate (RR) in bpm (breaths per minute), evaluated every day from 24 hours postoperative until time for readiness for hospital discharge
Temperature (°C), evaluated everyday from 24 hours postoperative to hospital discharge
Temperature (T°C), evaluated every day from 24 hours postoperative until time for readiness for hospital discharge
Overall patient's satisfaction (0-100%), evaluated everyday from 24 hours postoperative to hospital discharge
Overall patient's satisfaction, evaluated every day from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (unsatisfied) to 100% (fully satisfied)
Quality of recovery (QoR-15), evaluated every day from 24 hours postoperative to hospital discharge
Patients' perceived quality of recovery (QoR-15). This questionnaire includes 15 questions that are divided into 2 parts, part A contains the first 10 questions that are scored between 0 (never) and 10 (constantly), and part B contains the last 5 questions scored between 0 (constantly) and 10 (never). Evaluation test every day from 24 hours postoperative until time for readiness for hospital discharge
6-minutes walking score, evaluated every day from 24 hours postoperative to hospital discharge
6-minutes walking score. The object of this test is to walk as far as possible for 6 minutes in the hospital hallway. Six minutes is a long time to walk after this surgery type, so it's important to practise 6 Minute Walk every day on a flat hard surface. Evaluation test every day from 24 hours postoperative until time for readiness for hospital discharge
MOCA scores, evaluated every day from 24 hours postoperative to hospital discharge
MOCA (Montreal Cognitive Assessment) scores test for Dementia, range from zero to 30, with a score of 26 and higher generally considered normal. In the initial study data establishing the MoCA, normal controls had an average score of 27.4, compared with 22.1 in people with mild cognitive impairment (MCI) and 16.2 in people with Alzheimer's disease. Evaluation test every day from 24 hours postoperative until time for readiness for hospital discharge
Time for first walking/mobilization, evaluated every day from 24 hours postoperative to hospital discharge
The time for first walking/mobilization, consist to determine the precise moment when the patient is able to get up from his bed, and sit on a chair, with and without help
Time for first flatus, evaluated every day from 24 hours postoperative to hospital discharge
Determine the time of first flatus which are a sign of recovery of lower GI function
Time for return to food oral intake, evaluated every day from 24 hours postoperative to hospital
Patient is able to tolerate at least one solid meal without nausea, vomiting, bloating or worsening abdominal pain. Patient drinks liquids actively (ideally > 800-1000 ml/day) and do not require intravenous fluids infusion to maintain hydration
Biological analysis, evaluated every day from 24 hours postoperative to hospital discharge
Biological analysis, intraoperative and daily during the 21 postoperative days: serum electrolytes (Na+ Cl- Ca2+ Ca total Phophore, glycemia) creatinine, DFG, CRP, hemoglobin, white blood cell and platelet counts, serum albumin, INR, PTT
Rate of hospital readmission and mortality postoperative
Rate of hospital readmission and mortality postoperative up to 30 days following surgery

Full Information

First Posted
July 16, 2019
Last Updated
September 30, 2021
Sponsor
Ciusss de L'Est de l'Île de Montréal
search

1. Study Identification

Unique Protocol Identification Number
NCT04104334
Brief Title
Impact of an Optimised Monitored Anesthesia on the Patients' Recovery After Cytoreduction Surgery Plus HIPEC
Acronym
CHIPNOL
Official Title
Evaluation of the Impact of Combined Intraoperative Monitoring of Depth of Analgesia, Depth of Anesthesia and Continuous Hemodynamic Data on the Patients Recovery After Cytoreduction Surgery and Hyperthermic Intraperitoneal Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Change in surgical practice and chemotherapy treatment by the surgery team
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of our PILOT study is to evaluate the impact of a controlled (monitored) randomized anesthesia during cytoreductive surgery with HIPEC to oxaliplatin in order to treat adenocarcinomas of colorectal origin. The combination of NOL monitoring, BIS monitoring and continuous hemodynamic monitoring (FloTrac EV1000 system) can improve patient safety by reducing the length of hospital stay by decreasing total hypnotic doses and intraoperative opioids and side effects following anesthesia.
Detailed Description
Title: Evaluation of the combined intraoperative monitoring of depth of analgesia (NOL), depth of anesthesia (BIS) and continuous hemodynamic data (Flotrac EV1000 system) on the patients' recovery after cytoreduction surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). A pilot study. Hypothesis: Investigators hypothesize that the intraoperative combination of new monitors, NOL index for depth of analgesia, BIS index for depth of anesthesia and Flotrac EV1000 system as continuous hemodynamic monitoring, to guide the delivery of opioids, hypnotics, fluids and inotropes, respectively, will improve the quality of recovery as well as the safety after anesthesia in patients undergoing HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgery. Background: so far, only vital signs (mostly, blood pressure and heart rate) helped the anesthesiologist to administer hypnotics agents, analgesics, fluids and inotrope. Many devices have offered pain monitoring for anesthetized patients. The NOL index, a nociception monitor using a multiparametric approach, has shown an excellent sensitivity and specificity in detecting noxious stimuli under general anesthesia. More recently, it has been shown a strong inverse correlation between NOL index response to nociceptive stimulus and the increasing doses of opioid analgesia during surgery. Studies on post-operative outcomes when using intraoperative NOL monitoring to adapt nociception/anti-nociception balance during general anesthesia (GA) also reported in our center an improvement of the time to extubation and of the postoperative recovery criteria in PACU after colorectal surgery in the monitored group, leading to a quicker discharge from PACU (presented as an abstract at ASA 2018; manuscript in preparation). Recent studies also showed that avoiding too deep anesthesia by using the BIS index would improve patients' outcome in terms of morbi-mortality. It is also accepted that intra-venous fluid and inotropic/vasopressor drugs have an important effect on intra and postoperative patients' outcomes, in particular following major gastrointestinal surgery. The use of hemodynamic therapy management algorithms has been recommended in a report commissioned by the Centers for Medicare and Medicaid Services in the USA, and by the National Institute for Health and Care Excellence (NICE) in the UK as well as many groups working in ERAS protocols in Canada (and especially Montreal, McGill University) and worldwide. Based on our recent systematic review (in preparation) and out of the 69 selected published articles, there is no study so far evaluating precisely the impact of anesthesia on postoperative outcomes, and no study combining the NOL, the BIS indexes and the Flotrac EV1000 system to evaluate the impact of a more precise anesthesia management on the postoperative outcomes after cytoreduction and HIPEC for peritoneal carcinomatosis of colorectal origin. Thus, the idea to propose the present study. Specific Objectives: primary objective: to compare the time to reach the readiness for discharge from hospital and the total postoperative in-hospital length of stay between the Monitored group "M" (optimized, personalized and controlled anesthesia) versus the control group "C" (standard of care anesthesia). Secondary objectives: to evaluate the quality of recovery from anesthesia in the PACU and on the wards and all the adverse events every day and until patient's discharge from hospital. The emergence and extubation time of patients after anesthesia, time spent in PACU (Aldrete score), intra- and postoperative opioid requirements, pain scores (NRS) for several postoperative days, patients' postoperative recovery and satisfaction (the Quality of Recovery: QOR-15, 6min walking test, MOCA, etc.) will be also compared between the 2 groups. Finally, biological outcomes such as blood gas analysis, serum electrolytes, creatinine, DFG, hemoglobin, white blood cell and platelet counts, CRP, serum albumin, INR, PTT will be evaluated on a standard basis in both the groups. Methods: 80 patients scheduled for HIPEC surgery with oxaliplatin for bowel adenocarcinoma surgery (without digestive resection) will be included. Randomisation will occur after the participant has provided informed consent and shortly before the surgical procedure is due to start. Patients in the Control group "C" will be managed by clinical staff according to usual practice, desflurane will be administered to keep MAC at 1, and remifentanil infusion rate will be adapted to the mean arterial blood pressure to keep it between 65 and 100. In the Monitored group "M", the NOL index will guide the administration of remifentanil to keep the index between 5-25, and the desflurane will be titrated to keep a BIS index between 45 and 55. Cardiac output and stroke volume variation will be measured by the Flotrac EV1000 system. Patients will receive 250ml fluid challenges with a recommended solution as required, in order to achieve a maximal value of stroke volume. Intraoperative epidural analgesia will be the same for all. Postoperative analgesia will be based on PCEA and hydromorphone for all. All anesthesia related side effects and quality of analgesia and rehabilitation will be evaluated daily and until patient's discharge from hospital. Data Analysis: all data collected will be analyzed using an intent-to-treat approach. Summary statistics for each group, treatment effects, 95% confidence intervals, and p-values will be presented for primary and secondary outcomes, and process measures. Intraoperative data in the "M" and "C" groups will be compared using parametric (e.g. Student t-test) or non-parametric tests (e.g. Mann-Withney U test, Chi-squared test) depending on type of variables and distribution. General linear models will be used to carry out group comparisons on data on length of hospital stay. Potential pitfalls: analyses for secondary objectives may not be sufficiently powered but will nevertheless provide useful information for designing and conducting a future multicentric study. Bonferroni corrections will be used to protect against type I error. Significance/Importance: Adding the NOL, the BIS and continuous hemodynamic monitoring will very likely reduce the total length of stay, and improve the postoperative speed and quality of recovery as well as will likely reduce the incidence of complications after cytoreduction + HIPEC procedures. Study Design: Prospective, randomized controlled study. Subject Population: Adult patients scheduled to undergo laparotomy for cytoreduction surgery + HIPEC for peritoneal carcinomatosis of colorectal origin and under general anesthesia with an active intraoperative epidural analgesia. Sample Size: 80 patients will be evaluated in this study. Study Duration: 2 year(s) Study Center: Maisonneuve-Rosemont Hospital, Departments of Anesthesiology and Pain Medicine and Department of General Oncologic Surgery, CIUSSS de l'Est-de-l'Île-de-Montreal, Montreal, Quebec, Canada Adverse Events: None expected. Subvention/support: Department of Anesthesiology and Pain Medicine of HMR/CEMTL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermia, Colorectal Neoplasms, Oxaliplatin
Keywords
Cytoreduction, HIPEC, Oxaliplatin, Colorectal, Peritoneal, Carcinomatosis, Monitoring, Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups of patients. Randomization into Monitored group "M" (BIS + NOL + Flotrac EV1000) vs control group "C" (standard of care anesthesia) according to randomization list for a total number of 80 patients.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization into Monitored group "M" (BIS + NOL + Flotrac EV1000) vs control group "C" (standard of care anesthesia) will be done prior to the entrance in the OR, the day of the surgery.
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monitored group "M" (optimized controlled anesthesia)
Arm Type
Active Comparator
Arm Description
Patients in the Monitored group "M", the NOL index will guide the administration of remifentanil to keep the index between 5-25, and the desflurane will be titrated to keep a BIS index between 45 and 55. Cardiac output and stroke volume variation will be measured by the Flotrac EV1000 system. Patients will receive 250ml fluid challenges with a recommended solution as required, in order to achieve a maximal value of stroke volume.
Arm Title
Control group "C" (standard of care anesthesia)
Arm Type
Active Comparator
Arm Description
Patients in the Control group "C" will be managed by clinical staff according to usual practice, desflurane will be administered to keep MAC at 1, and remifentanil infusion rate will be adapted to the mean arterial blood pressure to keep it between 65 and 100.
Intervention Type
Drug
Intervention Name(s)
Remifentanil infusion, desflurane titration and fluid infusion will be guided by NOL index, BIS index and Flotrac EV1000 system respectively
Other Intervention Name(s)
Monitoring group
Intervention Description
NOL index will guide the administration of remifentanil to keep the index between 5-25, and the desflurane will be titrated to keep a BIS index between 45 and 55. Cardiac output and stroke volume variation will be measured by the Flotrac EV1000 system. Patients will receive 250ml fluid challenges with a recommended solution as required, in order to achieve a maximal value of stroke volume
Intervention Type
Drug
Intervention Name(s)
Remifentanil infusion and desflurane titration will be guided by anesthesia usual practices
Other Intervention Name(s)
Control group
Intervention Description
Desflurane will be administered to keep MAC at 1, and remifentanil infusion rate will be adapted to the mean arterial blood pressure to keep it between 65 and 100, according to anesthesia usual practices
Primary Outcome Measure Information:
Title
The hospital length of stay in days
Description
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012). After these criteria are achieved, discharge may take place.
Time Frame
Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
Title
Tolerance of oral intake
Description
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Tolerance of oral intake. After these criteria are achieved, discharge may take place.
Time Frame
Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
Title
Recovery of lower gastrointestinal function
Description
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Recovery of lower gastrointestinal function. After these criteria are achieved, discharge may take place.
Time Frame
Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
Title
Adequate pain control with oral analgesia
Description
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Adequate pain control with oral analgesia. After these criteria are achieved, discharge may take place.
Time Frame
Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
Title
Ability to mobilize and self-care
Description
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Ability to mobilize and self-care. After these criteria are achieved, discharge may take place.
Time Frame
Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
Title
Clinical examination and laboratory tests show no evidence of complications or untreated medical problems
Description
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Clinical examination and laboratory tests show no evidence of complications or untreated medical problems. After these criteria are achieved, discharge may take place.
Time Frame
Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
Secondary Outcome Measure Information:
Title
Intraoperative anesthetic gas' consumption in ml/kg/h
Description
Total consumption and absorption of desflurane in ml/kg/h during surgery and for each hour of surgery
Time Frame
Intraoperative
Title
Intraoperative remifentanil consumption in mcg/kg/min
Description
Total consumption of i.v. remifentanil during surgery and for each hour of surgery
Time Frame
Intraoperative
Title
Intraoperative fluid's consumption in ml/h
Description
Total of fluid perfused during surgery and for each hour of surgery
Time Frame
Intraoperative
Title
Intraoperative number of hypotensive events
Description
Total number of hypotensive events during surgery (defined as mean blood pressure below 60)
Time Frame
Intraoperative
Title
Intraoperative phenylephrine consumption in mcg/kg/min
Description
Total doses of intraoperative infused i.v. phenylephrine and doses per hour
Time Frame
Intraoperative
Title
Intraoperative epidural consumption in 3 ml/h
Description
Total doses of intraoperative Epidural infusion (lidocaine 2%+epinephrine) and doses per hour
Time Frame
Intraoperative
Title
Time for awakening in seconds
Description
Time for awakening (eyes opening) at the end of the surgery. Elapsed time in seconds between stopping the gas and opening the eyes of the patient
Time Frame
Intraoperative
Title
Time for extubation in seconds
Description
Time for extubation in seconds. Elapsed time in seconds between stopping the gas and patient's extubation
Time Frame
Intraoperative
Title
Time for transfert to the PACU in seconds
Description
Time for transfert to the PACU (Post Anesthesia Care Unit) in seconds, after extubatiuon
Time Frame
Intraoperative
Title
First NRS pain score (0-10 scale) at times of awakening
Description
NRS (Numeric Rating Scale) Pain Score evaluated at times of awakening, evaluation from 0 (no pain) to 10 (worst imaginable pain) scale
Time Frame
Intraoperative
Title
First NRS pain score (0-10 scale) at arrival in PACU
Description
First NRS Pain Score evaluated at arrival in PACU, evaluation from 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Postoperative, evaluated at arrival in PACU
Title
NRS pain score (0-10 scale) at rest, in PACU
Description
NRS Pain Score at rest, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Postoperative, evaluated every 15 minutes until time for PACU discharge
Title
NRS pain score (0-10 scale) with cough, in PACU
Description
NRS Pain Score with cough, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Postoperative, evaluated every 15 minutes until time for PACU discharge
Title
NRS pain score (0-10 scale) on the Shoulder, in PACU
Description
NRS Pain Score on the Shoulder, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Postoperative, evaluated every 15 minutes until time for PACU discharge
Title
Hydromorphone consumption (mg) in PACU
Description
Total cumulative dose of titration of intravenous hydromorphone (mg), evaluated every 15 minutes until time for readiness for PACU discharge
Time Frame
Postoperative, evaluated every 15 minutes until time for PACU discharge
Title
PONV score (0-3 scale) in PACU
Description
PONV (PostOperative Nausea and Vomiting) score, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no nausea) to 3 (nausea and vomiting)
Time Frame
Postoperative, evaluated every 15 minutes until time for PACU discharge
Title
POSS score (1-4 scale) in PACU
Description
POSS (Pasero Opioid-induced Sedation Scale) score evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 1 (awake and alert) to 5 (asleep deeply)
Time Frame
Postoperative, evaluated every 15 minutes until time for PACU discharge
Title
Respiratory depression number in PACU
Description
Respiratory depression number evaluated every 15 minutes until time for readiness for PACU discharge
Time Frame
Postoperative, evaluated every 15 minutes until time for PACU discharge
Title
Blood pressure (mmHg) in PACU
Description
Blood pressure (TAS/TAD/TAM) in mmHg evaluated every 15 minutes until time for readiness for PACU discharge
Time Frame
Postoperative, evaluated every 15 minutes until time for PACU discharge
Title
Time for PACU discharge based on Aldrete scores (0-10 scale), in PACU
Description
Time for readiness for PACU discharge based on Aldrete scores (0-10), Aldrete score must be ≥ 9 for PACU discharge
Time Frame
Postoperative, evaluated every 15 minutes until time for PACU discharge
Title
NRS pain score (0-10 scale) at rest, evaluated everyday from 24 hours postoperative to hospital discharge
Description
NRS Pain Score at rest, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
NRS pain score (0-10 scale) with cough, evaluated everyday from 24 hours postoperative to hospital discharge
Description
NRS Pain Score with cough, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
NRS pain score (0-10 scale) on the Shoulder, evaluated everyday from 24 hours postoperative to hospital discharge
Description
NRS Pain Score on the Shoulder, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Hydromorphone consumption (mg), evaluated everyday from 24 hours postoperative to hospital discharge
Description
Total cumulative dose of titration of intravenous hydromorphone (mg), evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Epidural consumption (mg), evaluated everyday from 24 hours postoperative to hospital discharge
Description
Total cumulative dose of titration of epidural (mg), evaluated every day, from 24 hours postoperative until the cessation of the PCEA (Patient Controlled Epidural Analgesia)
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
PONV score (0-3 scale), evaluated everyday from 24 hours postoperative to hospital discharge
Description
PONV (PostOperative Nausea and Vomiting) score, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no nausea) to 3 (nausea and vomiting)
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
POSS score (1-4 scale), evaluated everyday from 24 hours postoperative to hospital discharge
Description
POSS (Pasero Opioid-induced Sedation Scale) score evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 1 (awake and alert) to 5 (asleep deeply)
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Respiratory depression number, evaluated everyday from 24 hours postoperative to hospital discharge
Description
Respiratory depression number evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Blood pressure (mmHg), evaluated everyday from 24 hours postoperative to hospital discharge
Description
Blood pressure (TAS/TAD/TAM) in mmHg evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Heart rate (bpm), evaluated everyday from 24 hours postoperative to hospital discharge
Description
Heart rate (HR) in bpm (beats per minute), evaluated every day from 24 hours postoperative until time for readiness for hospital discharge
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Oxygen saturation (%), evaluated everyday from 24 hours postoperative to hospital discharge
Description
Oxygen saturation (SPO2) in %, evaluated every day from 24 hours postoperative until time for readiness for hospital discharge
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Respiratory rate (bpm), evaluated everyday from 24 hours postoperative to hospital discharge
Description
Respiratory rate (RR) in bpm (breaths per minute), evaluated every day from 24 hours postoperative until time for readiness for hospital discharge
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Temperature (°C), evaluated everyday from 24 hours postoperative to hospital discharge
Description
Temperature (T°C), evaluated every day from 24 hours postoperative until time for readiness for hospital discharge
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Overall patient's satisfaction (0-100%), evaluated everyday from 24 hours postoperative to hospital discharge
Description
Overall patient's satisfaction, evaluated every day from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (unsatisfied) to 100% (fully satisfied)
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Quality of recovery (QoR-15), evaluated every day from 24 hours postoperative to hospital discharge
Description
Patients' perceived quality of recovery (QoR-15). This questionnaire includes 15 questions that are divided into 2 parts, part A contains the first 10 questions that are scored between 0 (never) and 10 (constantly), and part B contains the last 5 questions scored between 0 (constantly) and 10 (never). Evaluation test every day from 24 hours postoperative until time for readiness for hospital discharge
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
6-minutes walking score, evaluated every day from 24 hours postoperative to hospital discharge
Description
6-minutes walking score. The object of this test is to walk as far as possible for 6 minutes in the hospital hallway. Six minutes is a long time to walk after this surgery type, so it's important to practise 6 Minute Walk every day on a flat hard surface. Evaluation test every day from 24 hours postoperative until time for readiness for hospital discharge
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
MOCA scores, evaluated every day from 24 hours postoperative to hospital discharge
Description
MOCA (Montreal Cognitive Assessment) scores test for Dementia, range from zero to 30, with a score of 26 and higher generally considered normal. In the initial study data establishing the MoCA, normal controls had an average score of 27.4, compared with 22.1 in people with mild cognitive impairment (MCI) and 16.2 in people with Alzheimer's disease. Evaluation test every day from 24 hours postoperative until time for readiness for hospital discharge
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Time for first walking/mobilization, evaluated every day from 24 hours postoperative to hospital discharge
Description
The time for first walking/mobilization, consist to determine the precise moment when the patient is able to get up from his bed, and sit on a chair, with and without help
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Time for first flatus, evaluated every day from 24 hours postoperative to hospital discharge
Description
Determine the time of first flatus which are a sign of recovery of lower GI function
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Time for return to food oral intake, evaluated every day from 24 hours postoperative to hospital
Description
Patient is able to tolerate at least one solid meal without nausea, vomiting, bloating or worsening abdominal pain. Patient drinks liquids actively (ideally > 800-1000 ml/day) and do not require intravenous fluids infusion to maintain hydration
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Biological analysis, evaluated every day from 24 hours postoperative to hospital discharge
Description
Biological analysis, intraoperative and daily during the 21 postoperative days: serum electrolytes (Na+ Cl- Ca2+ Ca total Phophore, glycemia) creatinine, DFG, CRP, hemoglobin, white blood cell and platelet counts, serum albumin, INR, PTT
Time Frame
Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days
Title
Rate of hospital readmission and mortality postoperative
Description
Rate of hospital readmission and mortality postoperative up to 30 days following surgery
Time Frame
Postoperative evaluation, up to 30 days following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA status I, II or III Patients older than 18 years HIPEC for bowel surgery with oxaliplatin + dextrose 5% for a duration of 30 min Duration and type of surgery requiring an epidural analgesia via an epidural catheter placed and tunnelled prior the general anesthesia induction and an arterial line placed after induction of general anesthesia. Exclusion Criteria: Any allergy to one drug used in our anesthesia or HIPEC protocol Any contra-indication or patient's refusal for epidural placement Chronic arrhythmic cardiac conditions Chronic pain with use of opioids more than 3 times per week for 4 weeks Bowel occlusion Physical/mental incapacities Unexpected difficult airway requesting excessive, possibly painful airway manipulations. Epidural failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe PR Richebé, MD PhD
Organizational Affiliation
CIUSSS Est de l'île de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal
City
Montréal-Est
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Impact of an Optimised Monitored Anesthesia on the Patients' Recovery After Cytoreduction Surgery Plus HIPEC

We'll reach out to this number within 24 hrs