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

H

Huazhong University of Science and Technology

Status and phase

Completed
Phase 4

Conditions

Laparoscopic Surgery
Hysteroscopic Surgery

Treatments

Drug: Sevoflurane+Propofol
Drug: Sevoflurane
Drug: Propofol for maintenance

Study type

Interventional

Funder types

Other

Identifiers

NCT01084200
TJHMZK01004

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 3 patient groups

Propofol
Experimental group
Description:
anesthesia maintenance with propofol and remifentanil
Treatment:
Drug: Propofol for maintenance
Sevoflurane
Experimental group
Description:
Sevoflurane and Remifentanil for anesthesia maintenance
Treatment:
Drug: Sevoflurane
Sevoflurane+Propofol
Experimental group
Description:
Sevoflurane+Propofol for anesthesia maintenance
Treatment:
Drug: Sevoflurane+Propofol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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