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

Condition(s) targeted: Laparoscopic Surgery; Hysteroscopic Surgery

Intervention: Propofol for maintenance (Drug); Sevoflurane (Drug); Sevoflurane+Propofol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Huazhong University of Science and Technology

Official(s) and/or principal investigator(s):
Wei Mei, M.D., Principal Investigator, Affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Yu Ke Tian, Prof. M.D., Study Chair, Affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Post operative pain determined by NRS at 0.5h after surgery

Secondary outcome:

Postoperative delirium

PONV

QOR

Post operative pain determined by NRS at 1h and 24h after surgery

Incidence of shivering in the first postoperative day.

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.

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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

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

Starting date: September 2009
Last updated: August 9, 2012