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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01084200
First received: March 8, 2010
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Laparoscopic Surgery
Hysteroscopic Surgery
Drug: Propofol for maintenance
Drug: Sevoflurane
Drug: Sevoflurane+Propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Postoperative Pain of Sevoflurane, Propofol, and Sevoflurane Plus Propofol in Maintenance of Anaesthesia for Gynaecological Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Post operative pain determined by NRS at 0.5h after surgery [ Time Frame: at 0.5h after the surgery ] [ Designated as safety issue: Yes ]
    The level of postoperative pain was assessed by Numerical Analogue Scale (NAS) at rest at 0.5 hour after the surgery.


Secondary Outcome Measures:
  • Postoperative delirium [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: Yes ]
    Postoperative delirium determined by Nu-DESC every 8 hours.

  • PONV [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: Yes ]
    Incidence of postoperative nausea and vomiting was assessed at 24h after the surgery.

  • QOR [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: Yes ]
    Quality of recovery was determined by QOR40 at 24h after the surgery

  • Post operative pain determined by NRS at 1h and 24h after surgery [ Time Frame: at 1h and 24h after surgery ] [ Designated as safety issue: Yes ]
    Post operative pain determined by NRS at 1h and 24h after surgery respectively.

  • Incidence of shivering in the first postoperative day. [ Time Frame: follow up at 24 h after the surgery ] [ Designated as safety issue: Yes ]
    Incidence of shivering was assessed at 24h after the surgery.


Enrollment: 90
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propofol
anesthesia maintenance with propofol and remifentanil
Drug: Propofol for maintenance
Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
Other Name: Propofol
Experimental: Sevoflurane
Sevoflurane and Remifentanil for anesthesia maintenance
Drug: Sevoflurane
Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
Other Name: Sevoflurane
Experimental: Sevoflurane+Propofol
Sevoflurane+Propofol for anesthesia maintenance
Drug: Sevoflurane+Propofol
Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance
Other Name: Sevoflurane and 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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01084200

Locations
China, Hubei
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Principal Investigator: Wei Mei, M.D. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Study Chair: Yu Ke Tian, Prof. M.D. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  More Information

Publications:
Responsible Party: Wei Mei, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01084200     History of Changes
Other Study ID Numbers: TJHMZK01004
Study First Received: March 8, 2010
Last Updated: August 9, 2012
Health Authority: China: Ministry of Health

Keywords provided by Huazhong University of Science and Technology:
Postoperative pain
Sevoflurane
Propofol
Female
Elective gynaecological surgery
Laparoscopic and hysteroscopic surgery
Female patients
Undergoing elective laparoscopic and hysteroscopic surgery

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014