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

NCT ID: NCT01084200

Last Updated: 2012-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Laparoscopic Surgery Hysteroscopic Surgery

Keywords

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Postoperative pain Sevoflurane Propofol Female Elective gynaecological surgery Laparoscopic and hysteroscopic surgery Female patients Undergoing elective laparoscopic and hysteroscopic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Propofol

anesthesia maintenance with propofol and remifentanil

Group Type EXPERIMENTAL

Propofol for maintenance

Intervention Type DRUG

Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance

Sevoflurane

Sevoflurane and Remifentanil for anesthesia maintenance

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance

Sevoflurane+Propofol

Sevoflurane+Propofol for anesthesia maintenance

Group Type EXPERIMENTAL

Sevoflurane+Propofol

Intervention Type DRUG

Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance

Interventions

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Propofol for maintenance

Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance

Intervention Type DRUG

Sevoflurane

Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance

Intervention Type DRUG

Sevoflurane+Propofol

Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance

Intervention Type DRUG

Other Intervention Names

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Propofol Sevoflurane and Propofol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Wei Mei

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Mei, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Yu Ke Tian, Prof. M.D.

Role: STUDY_CHAIR

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Locations

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Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 22192060 (View on PubMed)

Other Identifiers

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TJHMZK01004

Identifier Type: -

Identifier Source: org_study_id