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

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084200
• Other study ID #: TJHMZK01004
• Status: Completed
• Phase: Phase 4
• First received: March 8, 2010
• Last updated: August 9, 2012
• Start date: September 2009
• Est. completion date: January 2010

Study information

• Verified date: August 2012
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hysteroscopic Surgery
• Laparoscopic Surgery

Intervention

Drug:
• Propofol for maintenance
Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
• Sevoflurane
Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
• Sevoflurane+Propofol
Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance

Locations

Country	Name	City	State
China	Tongji Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain determined by NRS at 0.5h after 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	Yes
Secondary	Postoperative delirium	Postoperative delirium determined by Nu-DESC every 8 hours.	24 hours postoperatively	Yes
Secondary	PONV	Incidence of postoperative nausea and vomiting was assessed at 24h after the surgery.	24 hours postoperatively	Yes
Secondary	QOR	Quality of recovery was determined by QOR40 at 24h after the surgery	24 hours post operatively	Yes
Secondary	Post operative pain determined by NRS 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	Yes
Secondary	Incidence of shivering in the first postoperative day.	Incidence of shivering was assessed at 24h after the surgery.	follow up at 24 h after the surgery	Yes