Comparison of Propofol and Sevoflurane Anesthesia on the Quality of Recovery After Ambulatory Surgery in Obese Patients
Primary Purpose
Quality of Recovery
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Propofol
sevoflurane
Sponsored by
About this trial
This is an interventional supportive care trial for Quality of Recovery focused on measuring propofol, sevoflurane, obese, quality of recovery, anal fistula
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing selective surgery for anal fistula,
- aged 18-60 years,
- body mass index >30kg/m2,
- patient who required general anesthesia and signed informed consent,
- ASA I - II.
Exclusion Criteria:
- patients refused to participate in the test,
- patients with severe cardiac, pulmonary, liver and renal dysfunction,
- patients with severe central nervous system diseases or severe mental diseases,
- patients with a history of alcoholism,
- allergy to related anesthetics,
- pregnant or lactating women,
- participated in the other trials in the past month,
- taking any sedative, opioid, or sleep aid drugs,
- patients with other special conditions not suitable for this study, ____________________________________________.
Sites / Locations
- Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group PRO
Group SEVO
Arm Description
Anesthesia was induced by sufentanil citrate 0.2ug/kg and propofol in TCI effect compartment concentration 4-6ug/kg. Anesthesia was maintained with propofol in TCI effect compartment concentration 3-4ug/kg.
Anesthesia was induced by sufentanil citrate 0.2ug/kg and sevoflurane in the method of vital capacity with inspired-limb drug concentration measured upon 6%. Anesthesia was then maintained with sevoflurane in vaporizer concentration 1.5-2%.
Outcomes
Primary Outcome Measures
QoR-40 scales 24 hours after surgery
We evaluate the quality of recovery with QoR-40 questionnaire 24 hours after surgery. The Quality of Recovery-40 (QoR-40) questionnaire involves 5 dimensions: physical comfort, physical independence, emotional state, psychological support and pain.
Dimensions of the QoR-40 identified to represent aspects of good quality recovery after anesthesia and surgery. Positive items were scored from 1(worst) to 5(best); scores were reversed for negative items.
QoR-40 scales 48 hours after surgery
We evaluate the quality of recovery with QoR-40 questionnaire 48 hours after surgery. The Quality of Recovery-40 (QoR-40) questionnaire involves 5 dimensions: physical comfort, physical independence, emotional state, psychological support and pain.
Dimensions of the QoR-40 identified to represent aspects of good quality recovery after anesthesia and surgery. Positive items were scored from 1(worst) to 5(best); scores were reversed for negative items.
Secondary Outcome Measures
Duration of induction
From beginning of intravenous or inhalation of anesthetics to ending of inserting the LMA.
Duration of surgery
From beginning of skin cutting to ending of surgery.
Duration of emergence
From withdrawl time of intravenous or inhalation of anesthetics to awaking.
visual analogue scales for pain
visual analogue scales for pain in PACU
PONV
Postoperative nausea and vomiting in 24hours after surgery
total dosage of Analgesic drugs
Categories of analgesics and total dosage of analgesics in 24 hours after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05529875
Brief Title
Comparison of Propofol and Sevoflurane Anesthesia on the Quality of Recovery After Ambulatory Surgery in Obese Patients
Official Title
Comparison of Propofol and Sevoflurane Anesthesia on the Quality of Recovery After Ambulatory Surgery for Anal Fistula in Obese Patients: A Prospective, Randomized, Single-blinded, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
In the early stage of the research, this research was limited by the application permission of research drugs and instruments, and the research will have to be interrupted, which is extremely regrettable.
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jiangang Song
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
This study was designed to compare propofol intravenous anesthesia to sevoflurane inhalation anesthesia on the quality of recovery after surgery for anal fistula in obese patients. Propofol-based total intravenous anesthesia (TIVA) and sevoflurane inhalation anesthesia are the two main anesthesia techniques. Obesity influences not only anesthetics metabolic but also physical function of patients, so it is meaningful to study which anesthesia technique is better for the recovery of obese patients after surgery.
Detailed Description
This study was approved by Ethical Committee of ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese Medicine. Patients were given informed consent before enrolling the study, whereafter, they were randomized into two groups, propofol-based total intravenous anesthesia (Group PRO) and sevoflurane inhalation anesthesia (Group SEVO). After entering the routine, blood pressure, pulse oxygen saturation, and ECG were monitored by multifunctional anesthesia monitor and anesthesia depth was monitored by brain electrical bispectral index (BIS). Intravenous access (20-gauge catheter) was established and an infusion of lactated Ringer's solution began in the operating room. Patients were positioned as left or right lateral decubitus position according to surgery. Patients inhaled oxygen before anesthetic induction using a face mask. Intravenous penehyclidine hydrochloride 0.5mg, granisetron 3mg, and midazolam 2mg were given as premedication.
In Group PRO, anesthesia was induced by sufentanil citrate 0.2ug/kg and propofol in TCI effect compartment concentration 4-6ug/kg, until the patient loses consciousness, then laryngeal mask airway was inserted. Anesthesia was then maintained with propofol in TCI 3-4ug/kg, if the patient showed body movement, TCI was raised by 0.5 ug/kg every time, until the anesthesia depth was satisfied (no body movement, BIS40-60).
In Group SEVO, anesthesia was induced by sufentanil citrate 0.2ug/kg and sevoflurane. Firstly, mask was fixed with four head band, keeping it sealed. The method of vital capacity was used, taking deep breaths until the patient loses consciousness (call patients not to answer, the eyelash reflex disappeared, BIS40-60): close valve of APL to zero, empty the breathing bag, block the respiratory circuit, prime the circuit with 8% sevoflurane in O2 at 8 L/min until the inspired-limb drug concentration measured upon 6%. Then, laryngeal mask airway was inserted. Anesthesia was then maintained with sevoflurane, adjusting the oxygen flow rate to 2L/min and sevoflurane vaporizer concentration 1.5-2%, if the patient showed body movement and other narcotic lighter sign, sevoflurane vaporizer concentration was raised by 0.5% every time, until the anesthesia depth was satisfied (no body movement, BIS40-60).
The propofol and sevoflurane were closed at the end of surgery.
Quality of recovery was assessed using QoR-40 scale in day 1 and day 2 after surgery. Postoperative pain intensity was assessed using visual analogue scale in day 1 and day 2 after surgery. Surgical and waking time was recorded before leaving post-anesthesia care unit. Adverse events (circulation or respiratory depression, postoperative nausea and vomiting, recovery agitation) were recorded perioperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Recovery
Keywords
propofol, sevoflurane, obese, quality of recovery, anal fistula
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group PRO
Arm Type
Active Comparator
Arm Description
Anesthesia was induced by sufentanil citrate 0.2ug/kg and propofol in TCI effect compartment concentration 4-6ug/kg.
Anesthesia was maintained with propofol in TCI effect compartment concentration 3-4ug/kg.
Arm Title
Group SEVO
Arm Type
Active Comparator
Arm Description
Anesthesia was induced by sufentanil citrate 0.2ug/kg and sevoflurane in the method of vital capacity with inspired-limb drug concentration measured upon 6%.
Anesthesia was then maintained with sevoflurane in vaporizer concentration 1.5-2%.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Group PRO
Intervention Description
intravenous propofol using target-controlled infusion (TCI) devices.
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Other Intervention Name(s)
Group SEVO
Intervention Description
inhalator sevoflurane using sevoflurane vaporizer sevoflurane vaporizer.
Primary Outcome Measure Information:
Title
QoR-40 scales 24 hours after surgery
Description
We evaluate the quality of recovery with QoR-40 questionnaire 24 hours after surgery. The Quality of Recovery-40 (QoR-40) questionnaire involves 5 dimensions: physical comfort, physical independence, emotional state, psychological support and pain.
Dimensions of the QoR-40 identified to represent aspects of good quality recovery after anesthesia and surgery. Positive items were scored from 1(worst) to 5(best); scores were reversed for negative items.
Time Frame
24 hours after surgery
Title
QoR-40 scales 48 hours after surgery
Description
We evaluate the quality of recovery with QoR-40 questionnaire 48 hours after surgery. The Quality of Recovery-40 (QoR-40) questionnaire involves 5 dimensions: physical comfort, physical independence, emotional state, psychological support and pain.
Dimensions of the QoR-40 identified to represent aspects of good quality recovery after anesthesia and surgery. Positive items were scored from 1(worst) to 5(best); scores were reversed for negative items.
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
Duration of induction
Description
From beginning of intravenous or inhalation of anesthetics to ending of inserting the LMA.
Time Frame
Procedure (After inserting the laryngeal mask airway(LMA ))
Title
Duration of surgery
Description
From beginning of skin cutting to ending of surgery.
Time Frame
Intraoperative
Title
Duration of emergence
Description
From withdrawl time of intravenous or inhalation of anesthetics to awaking.
Time Frame
procedure (After emergence from anesthesia)
Title
visual analogue scales for pain
Description
visual analogue scales for pain in PACU
Time Frame
1 day (at the time of leaving PACU)
Title
PONV
Description
Postoperative nausea and vomiting in 24hours after surgery
Time Frame
24 hours after surgery
Title
total dosage of Analgesic drugs
Description
Categories of analgesics and total dosage of analgesics in 24 hours after surgery
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing selective surgery for anal fistula,
aged 18-60 years,
body mass index >30kg/m2,
patient who required general anesthesia and signed informed consent,
ASA I - II.
Exclusion Criteria:
patients refused to participate in the test,
patients with severe cardiac, pulmonary, liver and renal dysfunction,
patients with severe central nervous system diseases or severe mental diseases,
patients with a history of alcoholism,
allergy to related anesthetics,
pregnant or lactating women,
participated in the other trials in the past month,
taking any sedative, opioid, or sleep aid drugs,
patients with other special conditions not suitable for this study, ____________________________________________.
Facility Information:
Facility Name
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201203
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Propofol and Sevoflurane Anesthesia on the Quality of Recovery After Ambulatory Surgery in Obese Patients
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