Comparison of Postoperative Pain of Sevoflurane, Propofol, and Sevoflurane Plus Propofol in Maintenance of Anaesthesia for Gynaecological Laparoscopic Surgery
Overview
- Phase
- Phase 4
- Intervention
- Propofol for maintenance
- Conditions
- Laparoscopic Surgery
- Sponsor
- Huazhong University of Science and Technology
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Post operative pain determined by NRS at 0.5h after surgery
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Wei Mei
Associate Professor
Huazhong University of Science and Technology
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
Arms & Interventions
Propofol
anesthesia maintenance with propofol and remifentanil
Intervention: Propofol for maintenance
Sevoflurane
Sevoflurane and Remifentanil for anesthesia maintenance
Intervention: Sevoflurane
Sevoflurane+Propofol
Sevoflurane+Propofol for anesthesia maintenance
Intervention: Sevoflurane+Propofol
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Postoperative delirium(24 hours postoperatively)
- PONV(24 hours postoperatively)
- QOR(24 hours post operatively)
- Post operative pain determined by NRS at 1h and 24h after surgery(at 1h and 24h after surgery)
- Incidence of shivering in the first postoperative day.(follow up at 24 h after the surgery)