Clinical trial NCT01084200: Comparison of Sevoflurane, Propofol, and Sevoflurane Plus Propofol for Maintenance of Anaesthesia
Official title: Comparison of Postoperative Pain of Sevoflurane, Propofol, and Sevoflurane Plus Propofol in Maintenance of Anaesthesia for Gynaecological Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Surgery
Hysteroscopic Surgery
Keywords: Postoperative pain
Sevoflurane
Propofol
Female
Elective gynaecological surgery
Laparoscopic and hysteroscopic surgery
Female patients
Undergoing elective laparoscopic and hysteroscopic surgery
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Post operative pain determined by NRS at 0.5h after surgery
timeFrame: at 0.5h after the surgery
Secondary outcomes:
measure: Postoperative delirium
timeFrame: 24 hours postoperatively
measure: PONV
timeFrame: 24 hours postoperatively
measure: QOR
timeFrame: 24 hours post operatively
measure: Post operative pain determined by NRS at 1h and 24h after surgery
timeFrame: at 1h and 24h after surgery
measure: Incidence of shivering in the first postoperative day.
timeFrame: follow up at 24 h after the surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Wei Mei, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Yu Ke Tian, Prof. M.D.
role: STUDY_CHAIR
References:
citation: Li M, Mei W, Wang P, Yu Y, Qian W, Zhang ZG, Tian YK. Propofol reduces early post-operative pain after gynecological laparoscopy. Acta Anaesthesiol Scand. 2012 Mar;56(3):368-75. doi: 10.1111/j.1399-6576.2011.02603.x. Epub 2011 Dec 23.