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Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
Romania
Study Type
Interventional
Intervention
TIVA+lidocaine
Sevoflurane+lidocaine
TIVA+placebo
Sevoflurane+placebo
Sponsored by
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colorectal cancer, TIVA, sevoflurane, lidocaine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective surgery

Exclusion Criteria:

  • • persistent chronic pain

    • chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
    • Contraindications for any of the study medications
    • Significant psychiatric disorders (Axa I) (major depression, bipolar disorders, schizophrenia, etc.)
    • Significant hepatic (ALAT and/or ASAT > 2 normal values) or renal (plasma creatinine > 2 mg/dl) disorders
    • Convulsive disorders requiring medication during the last 2 years
    • Planned regional analgesia/anesthesia (spinal or epidural)
    • Corticoid dependent asthma
    • Autoimmune disorders
    • Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
    • Refusal for study participation

Sites / Locations

  • Clinica ATI, str Croitorilor nr 19-21Recruiting
  • Institutul Oncologic Prof Dr Ion ChiricutaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Active Comparator

Arm Label

TIVA + lidocaine

TIVA+placebo

Sevoflurane+placebo

Sevoflurane+lidocaine

Arm Description

TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion. Interventions: TIVA+lidocaine

TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)

Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo). Intervention: sevoflurane anesthesia +placebo (saline infusion)

Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively. Intervention: sevoflurane anesthesia+ lidocaine infusion

Outcomes

Primary Outcome Measures

Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer
Survival at 5 years will be recorded
Incidence of recurrences:
The incidence of recurrences will be registered annually and reported from the first year to 5 years respectively in all 4 groups of patients.

Secondary Outcome Measures

Morphine consumption during the first 24 postoperative hours
Total morphine consumption during the first 24h after surgery will be recorded
Severity of postoperative pain - verbal response pain (VRPS) score 1-10, (1=no pain, 10=worst pain) in recovery room and during the first 48 hrs postoperatively. Target verbal response pain score ≤3
The severity of postoperative pain will be recorded along with morphine consumption.Pain intensity will be followed during the first 48 h postoperatively.
Resumption of bowel function
Time to first flatus will be registered and compared between groups.
Length of hospital stay
LOS will be registered and compared between study groups.
Postoperative chronic pain
Chronic pain at 6 month and 1 year respectively will be assessed with McGill questionnaire by telephone interview. Scores range from 0 (no pain) to 78 (severe pain), patients with high scores need to seek medical advice
Postoperative imflamation
Evaluation of the influence of lidocaine on 24-hour postoperative inflammatory response; All patients will have leukocytes count and c protein reactive (PCR) so an analysis can be made.
Rate of postoperative complications after intravenous lidocaine infusion versus placebo
Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia
Rate of postoperative complications after TIVA versus inhalation anaesthesia
Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia

Full Information

First Posted
May 23, 2016
Last Updated
January 14, 2022
Sponsor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Collaborators
Prof. Dr. I. Chiricuta Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT02786329
Brief Title
Anesthesia and Postoperative Outcome in Colorectal Cancer Patients
Official Title
The Influence of Anesthesia on Postoperative Outcome and Complications in Colorectal Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Collaborators
Prof. Dr. I. Chiricuta Institute of Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without lidocaine on postoperative short and long term outcome in patients with colorectal cancer undergoing surgery. As short term endpoints postoperative pain and opioid consumption, resumption of bowel function, PONV, LOS will be registered. Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer recurrences incidence and mortality.
Detailed Description
Main goals Comparative evaluation of the incidence of recurrences after TIVA vs sevoflurane anesthesia Evaluation of the effect of lidocaine infusion associated with TIVA/sevoflurane on the incidence of chronic pain and of cancer recurrences and survival. Secondary objectives Evaluation of the influence of lidocaine on postoperative outcome in patients with colorectal cancer Evaluation of the influence of lidocaine on postoperative inflammatory response Evaluation of the influence of lidocaine on the incidence and severity of postoperative pain and outcome in patients with colorectal cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, TIVA, sevoflurane, lidocaine

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIVA + lidocaine
Arm Type
Active Comparator
Arm Description
TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion. Interventions: TIVA+lidocaine
Arm Title
TIVA+placebo
Arm Type
Placebo Comparator
Arm Description
TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)
Arm Title
Sevoflurane+placebo
Arm Type
Placebo Comparator
Arm Description
Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo). Intervention: sevoflurane anesthesia +placebo (saline infusion)
Arm Title
Sevoflurane+lidocaine
Arm Type
Active Comparator
Arm Description
Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively. Intervention: sevoflurane anesthesia+ lidocaine infusion
Intervention Type
Drug
Intervention Name(s)
TIVA+lidocaine
Other Intervention Name(s)
TIVA-L
Intervention Description
Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
Intervention Type
Drug
Intervention Name(s)
Sevoflurane+lidocaine
Other Intervention Name(s)
Sevo-L
Intervention Description
Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
Intervention Type
Drug
Intervention Name(s)
TIVA+placebo
Other Intervention Name(s)
TIVA-P
Intervention Description
Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
Intervention Type
Drug
Intervention Name(s)
Sevoflurane+placebo
Other Intervention Name(s)
Sevo-P
Intervention Description
Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively
Primary Outcome Measure Information:
Title
Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer
Description
Survival at 5 years will be recorded
Time Frame
5 years
Title
Incidence of recurrences:
Description
The incidence of recurrences will be registered annually and reported from the first year to 5 years respectively in all 4 groups of patients.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Morphine consumption during the first 24 postoperative hours
Description
Total morphine consumption during the first 24h after surgery will be recorded
Time Frame
0- 24 h
Title
Severity of postoperative pain - verbal response pain (VRPS) score 1-10, (1=no pain, 10=worst pain) in recovery room and during the first 48 hrs postoperatively. Target verbal response pain score ≤3
Description
The severity of postoperative pain will be recorded along with morphine consumption.Pain intensity will be followed during the first 48 h postoperatively.
Time Frame
0- 48 h
Title
Resumption of bowel function
Description
Time to first flatus will be registered and compared between groups.
Time Frame
0-72 h
Title
Length of hospital stay
Description
LOS will be registered and compared between study groups.
Time Frame
0-10 days
Title
Postoperative chronic pain
Description
Chronic pain at 6 month and 1 year respectively will be assessed with McGill questionnaire by telephone interview. Scores range from 0 (no pain) to 78 (severe pain), patients with high scores need to seek medical advice
Time Frame
1 year
Title
Postoperative imflamation
Description
Evaluation of the influence of lidocaine on 24-hour postoperative inflammatory response; All patients will have leukocytes count and c protein reactive (PCR) so an analysis can be made.
Time Frame
Day 1
Title
Rate of postoperative complications after intravenous lidocaine infusion versus placebo
Description
Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia
Time Frame
0-30 days
Title
Rate of postoperative complications after TIVA versus inhalation anaesthesia
Description
Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia
Time Frame
0-30 days
Other Pre-specified Outcome Measures:
Title
Rate of local anaesthetics systemic toxicity incidence
Description
An investigator will note any signs of local anaesthetics systemic toxicity at the bed site of patient
Time Frame
0-48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective surgery Exclusion Criteria: • persistent chronic pain chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids Contraindications for any of the study medications Significant psychiatric disorders (Axa I) (major depression, bipolar disorders, schizophrenia, etc.) Significant hepatic (ALAT and/or ASAT > 2 normal values) or renal (plasma creatinine > 2 mg/dl) disorders Convulsive disorders requiring medication during the last 2 years Planned regional analgesia/anesthesia (spinal or epidural) Corticoid dependent asthma Autoimmune disorders Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects Refusal for study participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela IONESCU, Prof
Phone
+40744771209
Email
dionescuati@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandru Alexa, Assist Prof
Phone
+40752691911
Email
alexandru_reziati@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Ionescu, Prof
Organizational Affiliation
Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandru Alexa, Assist Prof
Organizational Affiliation
Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica ATI, str Croitorilor nr 19-21
City
Cluj-napoca
State/Province
Cluj
ZIP/Postal Code
400162
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Ionescu, Prof
Phone
+40744771209
Email
dionescuati@yahoo.com
First Name & Middle Initial & Last Name & Degree
Alexa Alexandru, Assit Prof
Phone
+40752691911
Email
alexandru_reziati@yahoo.com
First Name & Middle Initial & Last Name & Degree
Tiberiu Tat, PhD student
First Name & Middle Initial & Last Name & Degree
Alexandru Alexa, PhD student
Facility Name
Institutul Oncologic Prof Dr Ion Chiricuta
City
Cluj-Napoca
State/Province
Cluj
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiberiu Tat, doctor
Email
dr_tibi@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Regular meeting for sharing data.
IPD Sharing Time Frame
Data will be shared between cooperation institutions every 3 month and whenever necessary.
IPD Sharing Access Criteria
Access criteria are: active involvement into the study, the need to register data into the common database. The need to report data into the PhD thesis is also an access criteria.
Citations:
PubMed Identifier
24683330
Citation
Fodale V, D'Arrigo MG, Triolo S, Mondello S, La Torre D. Anesthetic techniques and cancer recurrence after surgery. ScientificWorldJournal. 2014 Feb 6;2014:328513. doi: 10.1155/2014/328513. eCollection 2014.
Results Reference
background
PubMed Identifier
23242747
Citation
Heaney A, Buggy DJ. Can anaesthetic and analgesic techniques affect cancer recurrence or metastasis? Br J Anaesth. 2012 Dec;109 Suppl 1:i17-i28. doi: 10.1093/bja/aes421.
Results Reference
background
PubMed Identifier
23525301
Citation
Mao L, Lin S, Lin J. The effects of anesthetics on tumor progression. Int J Physiol Pathophysiol Pharmacol. 2013;5(1):1-10. Epub 2013 Mar 8.
Results Reference
background
PubMed Identifier
25379840
Citation
Cakmakkaya OS, Kolodzie K, Apfel CC, Pace NL. Anaesthetic techniques for risk of malignant tumour recurrence. Cochrane Database Syst Rev. 2014 Nov 7;2014(11):CD008877. doi: 10.1002/14651858.CD008877.pub2.
Results Reference
background
PubMed Identifier
25769963
Citation
Cassinello F, Prieto I, del Olmo M, Rivas S, Strichartz GR. Cancer surgery: how may anesthesia influence outcome? J Clin Anesth. 2015 May;27(3):262-72. doi: 10.1016/j.jclinane.2015.02.007. Epub 2015 Mar 11.
Results Reference
background
PubMed Identifier
24803747
Citation
Divatia JV, Ambulkar R. Anesthesia and cancer recurrence: What is the evidence? J Anaesthesiol Clin Pharmacol. 2014 Apr;30(2):147-50. doi: 10.4103/0970-9185.129990. No abstract available.
Results Reference
background
PubMed Identifier
17197840
Citation
Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
Results Reference
result
PubMed Identifier
20518581
Citation
McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
Results Reference
result
PubMed Identifier
35303929
Citation
Alexa AL, Tat TF, Ionescu D. The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study. Trials. 2022 Mar 18;23(1):219. doi: 10.1186/s13063-022-06157-4.
Results Reference
derived

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Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

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