Risk Factors for Post Operative Nausea and Vomiting(PONV) in Patients Underwent Gynecological Operation Under General Anesthesia

July 30, 2012 updated by: Wei Mei, Huazhong University of Science and Technology

A Observational Cohort Study to Identify Risk Factors for Post Operative Nausea and Vomiting Following General Anesthesia in Female Patient Underwent Gynecological Operation

Risk factors for postoperative nausea and vomiting(PONV) such as past history of PONV and/or motion sickness, non-smoking status, female gender, planned opiate use for post-operative analgesia were identified in white people. Whereas, risk factors for PONV in female patient with mongolian race were not clear. As a different life style and genetic background, new risk factors may associate with PONV in this population. The present study is a prospective cohort study to identify risk factors for PONV within 24 postoperative hours in chinese female patients underwent gynecology operative under general anesthesia.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

774

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients underwent gynecological operation under general anesthesia between 2009.02 and 2009.05.

Description

Inclusion Criteria:

  • >18 years old
  • Chinese female patient

Exclusion Criteria:

  • Unstable vital sign
  • Patients under mechanical ventilation
  • Patients under sedition (RASS=<-2)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PONV group
patients with postoperative nausea and vomiting
Control group
patients without postoperative nausea and vomiting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative nausea and vomiting
Time Frame: within 24 postoperative hours
within 24 postoperative hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative shivering
Time Frame: within 24 postoperative hours
within 24 postoperative hours
Postoperative pain score with Numerical Rating Scale (NRS-11)
Time Frame: within 24 postoperative hours
within 24 postoperative hours
Time to full recovery of intestinal function
Time Frame: within 24 postoperative hours
within 24 postoperative hours
Preoperative and postoperative fasting time
Time Frame: within 24 postoperative hours
within 24 postoperative hours
Length of postoperative hospital stay and Length of hospital stay
Time Frame: before discharge
before discharge
Total health care costs
Time Frame: before discharge
before discharge
Postoperative delirium in recovery room
Time Frame: within PACU stay
within PACU stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Investigators

  • Study Chair: Yuke Tian, M.D., PhD., Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Study Director: Wei Mei, M.D., Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJHMZK01003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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