Comparison of Propofol and Sevoflurane Anesthesia on the Quality of Recovery After Ambulatory Surgery in Obese Patients

Not Applicable

Withdrawn

• Conditions: Quality of Recovery
• Interventions: Drug: sevoflurane; Drug: Propofol

• Registration Number: NCT05529875
• Lead Sponsor: Jiangang Song

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.

Study Timeline

• Study First Submitted: 2022-05-07
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-06
• Last Update Submitted: 2022-09-06
• Study First Posted: 2022-09-07
• Last Update Posted: 2022-09-07
• Study Start: 2022-10
• Primary Completion: 2023-10
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients undergoing selective surgery for anal fistula,
2. aged 18-60 years,
3. body mass index >30kg/m2,
4. patient who required general anesthesia and signed informed consent,
5. ASA I - II.

Exclusion Criteria

1. patients refused to participate in the test,
2. patients with severe cardiac, pulmonary, liver and renal dysfunction,
3. patients with severe central nervous system diseases or severe mental diseases,
4. patients with a history of alcoholism,
5. allergy to related anesthetics,
6. pregnant or lactating women,
7. participated in the other trials in the past month,
8. taking any sedative, opioid, or sleep aid drugs,
9. patients with other special conditions not suitable for this study, ____________________________________________.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group SEVO	sevoflurane	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%.
Group PRO	Propofol	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.

Primary Outcome Measures

Name	Time	Method
QoR-40 scales 48 hours after surgery	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.
QoR-40 scales 24 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Duration of surgery	Intraoperative	From beginning of skin cutting to ending of surgery.
Duration of induction	Procedure (After inserting the laryngeal mask airway(LMA ))	From beginning of intravenous or inhalation of anesthetics to ending of inserting the LMA.
total dosage of Analgesic drugs	24 hours after surgery	Categories of analgesics and total dosage of analgesics in 24 hours after surgery
Duration of emergence	procedure (After emergence from anesthesia)	From withdrawl time of intravenous or inhalation of anesthetics to awaking.
visual analogue scales for pain	1 day (at the time of leaving PACU)	visual analogue scales for pain in PACU
PONV	24 hours after surgery	Postoperative nausea and vomiting in 24hours after surgery

Trial Locations

Locations (1)

Shuguang Hospital of Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China