Comparison of Sevoflurane, Propofol, and Sevoflurane Plus Propofol for Maintenance of Anaesthesia

August 9, 2012 updated by: Wei Mei, Huazhong University of Science and Technology

Comparison of Postoperative Pain of Sevoflurane, Propofol, and Sevoflurane Plus Propofol in Maintenance of Anaesthesia for Gynaecological Laparoscopic Surgery

Postoperative pain may be affected by general anaesthetics. The effect of propofol and sevoflurane on postoperative pain in chinese female patients has not been demonstrated before. This study compared the postoperative pain score in patients under general anaesthesia maintained with propofol,sevoflurane, or sevoflurane+propofol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of female patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I or II, suffering from infertilities, and undergoing selective gynaecological laparoscopic and hysteroscopic surgery. All the patients were randomly assigned to receive propofol,sevoflurane,or sevoflurane+propofol for anaesthesia maintenance. The primary outcome measure was the level of postoperative pain assessed by Numerical Analogue Scale (NAS) at rest 0.5 hour after the operation. The secondary outcomes were postoperative pain assessed by Numerical Analogue Scale (NAS) at rest 1 and 24 hour after the operation, the incidence of postoperative nausea and vomiting, the incidence of shiver, and quality of recovery determined by QOR40 in the first 24 h after surgery.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA physical status class 1 or 2
  • Aged >=18 years and =<40 years old
  • Suffering from infertilities
  • Under elective gynaecological laparoscopic and hysteroscopic surgery

Exclusion Criteria:

  • ASA-PS>=III
  • Aged under 18 yrs or above 40 yrs old
  • Body mass index (BMI) >30
  • Respiratory or Neurologic disease
  • Chronic antidepressants and Anticonvulsant drugs
  • Chronic analgesics intake
  • A known allergy to the drugs being used
  • History of substance abuse
  • Participating in the investigation of another experimental agent
  • Participating in the investigation of another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol
anesthesia maintenance with propofol and remifentanil
Drug: Propofol for maintenance
Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
Other Names:
  • Propofol
Experimental: Sevoflurane
Sevoflurane and Remifentanil for anesthesia maintenance
Drug: Sevoflurane
Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
Experimental: Sevoflurane+Propofol
Sevoflurane+Propofol for anesthesia maintenance
Drug: Sevoflurane+Propofol
Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance
Other Names:
  • Sevoflurane and Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain determined by NRS at 0.5h after surgery
Time Frame: at 0.5h after the surgery
The level of postoperative pain was assessed by Numerical Analogue Scale (NAS) at rest at 0.5 hour after the surgery.
at 0.5h after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative delirium
Time Frame: 24 hours postoperatively
Postoperative delirium determined by Nu-DESC every 8 hours.
24 hours postoperatively
PONV
Time Frame: 24 hours postoperatively
Incidence of postoperative nausea and vomiting was assessed at 24h after the surgery.
24 hours postoperatively
QOR
Time Frame: 24 hours post operatively
Quality of recovery was determined by QOR40 at 24h after the surgery
24 hours post operatively
Post operative pain determined by NRS at 1h and 24h after surgery
Time Frame: at 1h and 24h after surgery
Post operative pain determined by NRS at 1h and 24h after surgery respectively.
at 1h and 24h after surgery
Incidence of shivering in the first postoperative day.
Time Frame: follow up at 24 h after the surgery
Incidence of shivering was assessed at 24h after the surgery.
follow up at 24 h after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Investigators

  • Principal Investigator: Wei Mei, M.D., Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Study Chair: Yu Ke Tian, Prof. M.D., Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

August 10, 2012

Last Update Submitted That Met QC Criteria

August 9, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJHMZK01004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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