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

NCT05529875 | Withdrawn

• 1 other identifier: 20160401
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Recovery

Keywords

propofol; sevoflurane; obese; quality of recovery; anal fistula

Outcome Measures

Primary Outcomes (2)

• 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.

  24 hours after surgery

• 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.

  48 hours after surgery

Secondary Outcomes (6)

• Duration of induction

  Procedure (After inserting the laryngeal mask airway(LMA ))

• Duration of surgery

  Intraoperative

• Duration of emergence

  procedure (After emergence from anesthesia)

• visual analogue scales for pain

  1 day (at the time of leaving PACU)

• PONV

  24 hours after surgery

Study Arms (2)

Group PRO

ACTIVE COMPARATOR

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.

Drug: Propofol

Group SEVO

ACTIVE COMPARATOR

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%.

Drug: sevoflurane

Interventions

Propofol DRUG

intravenous propofol using target-controlled infusion (TCI) devices.

Also known as: Group PRO

Group PRO

sevoflurane DRUG

inhalator sevoflurane using sevoflurane vaporizer sevoflurane vaporizer.

Also known as: Group SEVO

Group SEVO

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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, \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_.

Sponsors & Collaborators

• Jiangang Song: lead

Study Sites (1)

Shuguang Hospital of Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201203, China

Location

Related Publications (15)

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• Leger M, Campfort M, Cayla C, Lasocki S, Rineau E. Postoperative quality of recovery measurements as endpoints in comparative anaesthesia studies: a systematic review. Br J Anaesth. 2021 Jun;126(6):e210-e212. doi: 10.1016/j.bja.2021.03.008. Epub 2021 Apr 21. No abstract available.

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  PMID: 34873432 RESULT

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  PMID: 10758459 RESULT

MeSH Terms

Conditions

Obesity; Rectal Fistula

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Anesthesiology

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: September 7, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)