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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01020201
First received: November 24, 2009
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
Anesthesia, General
Elective Gynecological Operation
Chinese Female Patient
Adult

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Observational Cohort Study to Identify Risk Factors for Post Operative Nausea and Vomiting Following General Anesthesia in Female Patient Underwent Gynecological Operation

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Incidence of postoperative nausea and vomiting [ Time Frame: within 24 postoperative hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of postoperative shivering [ Time Frame: within 24 postoperative hours ] [ Designated as safety issue: No ]
  • Postoperative pain score with Numerical Rating Scale (NRS-11) [ Time Frame: within 24 postoperative hours ] [ Designated as safety issue: No ]
  • Time to full recovery of intestinal function [ Time Frame: within 24 postoperative hours ] [ Designated as safety issue: No ]
  • Preoperative and postoperative fasting time [ Time Frame: within 24 postoperative hours ] [ Designated as safety issue: No ]
  • Length of postoperative hospital stay and Length of hospital stay [ Time Frame: before discharge ] [ Designated as safety issue: No ]
  • Total health care costs [ Time Frame: before discharge ] [ Designated as safety issue: No ]
  • Postoperative delirium in recovery room [ Time Frame: within PACU stay ] [ Designated as safety issue: No ]

Enrollment: 774
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
PONV group
patients with postoperative nausea and vomiting
Control group
patients without postoperative nausea and vomiting

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • >18 years old
  • Chinese female patient

Exclusion Criteria:

  • Unstable vital sign
  • Patients under mechanical ventilation
  • Patients under sedition (RASS=<-2)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020201

Locations
China, Hubei
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Wei Mei, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01020201     History of Changes
Other Study ID Numbers: TJHMZK01003
Study First Received: November 24, 2009
Last Updated: July 30, 2012
Health Authority: China: Health Department of Hubei Province

Keywords provided by Huazhong University of Science and Technology:
Anesthesia, General
Elective Gynecological Operation
Chinese female patient
Adult

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Vomiting
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013