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

Phase 4

Completed

• Conditions: Laparoscopic Surgery; Hysteroscopic Surgery
• Interventions: Drug: Propofol for maintenance; Drug: Sevoflurane+Propofol; Drug: Sevoflurane

• Registration Number: NCT01084200
• Lead Sponsor: Huazhong University of Science and Technology

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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-09
• Last Update Posted: 2012-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol for maintenance	anesthesia maintenance with propofol and remifentanil
Sevoflurane+Propofol	Sevoflurane+Propofol	Sevoflurane+Propofol for anesthesia maintenance
Sevoflurane	Sevoflurane	Sevoflurane and Remifentanil for anesthesia maintenance

Primary Outcome Measures

Name	Time	Method
Post operative pain determined by NRS at 0.5h after surgery	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 Outcome Measures

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

Trial Locations

Locations (1)

Tongji Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China