NCT01084200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

March 8, 2010

Last Update Submit

August 9, 2012

Conditions

Laparoscopic SurgeryHysteroscopic Surgery

Keywords

Postoperative painSevofluranePropofolFemaleElective gynaecological surgeryLaparoscopic and hysteroscopic surgeryFemale patientsUndergoing elective laparoscopic and hysteroscopic surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Postoperative delirium

    24 hours postoperatively

  • PONV

    24 hours postoperatively

  • QOR

    24 hours post operatively

  • Post operative pain determined by NRS at 1h and 24h after surgery

    at 1h and 24h after surgery

  • Incidence of shivering in the first postoperative day.

    follow up at 24 h after the surgery

Study Arms (3)

Propofol

EXPERIMENTAL

anesthesia maintenance with propofol and remifentanil

Drug: Propofol for maintenance

Sevoflurane

EXPERIMENTAL

Sevoflurane and Remifentanil for anesthesia maintenance

Drug: Sevoflurane

Sevoflurane+Propofol

EXPERIMENTAL

Sevoflurane+Propofol for anesthesia maintenance

Drug: Sevoflurane+Propofol

Interventions

Propofol for maintenanceDRUG

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

Also known as: Propofol
Propofol
SevofluraneDRUG

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

Sevoflurane
Sevoflurane+PropofolDRUG

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

Also known as: Sevoflurane and Propofol
Sevoflurane+Propofol

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status class 1 or 2
  • Aged \>=18 years and =\<40 years old
  • Suffering from infertilities
  • Under elective gynaecological laparoscopic and hysteroscopic surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Related 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.

    PMID: 22192060RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

PropofolMaintenanceSevoflurane

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsHealth Care Facilities Workforce and ServicesMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Wei Mei, M.D.

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

    PRINCIPAL INVESTIGATOR

  • Yu Ke Tian, Prof. M.D.

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 10, 2010

Study Start

September 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 10, 2012

Record last verified: 2012-08

Locations

CN(1)