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

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ClinicalTrials.gov Identifier: NCT01020201
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : July 31, 2012
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Anesthesia, General Elective Gynecological Operation Chinese Female Patient Adult

Study Design
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Study Type : Observational
Actual Enrollment : 774 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

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Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of postoperative nausea and vomiting [ Time Frame: within 24 postoperative hours ]

Secondary Outcome Measures :
  1. Incidence of postoperative shivering [ Time Frame: within 24 postoperative hours ]
  2. Postoperative pain score with Numerical Rating Scale (NRS-11) [ Time Frame: within 24 postoperative hours ]
  3. Time to full recovery of intestinal function [ Time Frame: within 24 postoperative hours ]
  4. Preoperative and postoperative fasting time [ Time Frame: within 24 postoperative hours ]
  5. Length of postoperative hospital stay and Length of hospital stay [ Time Frame: before discharge ]
  6. Total health care costs [ Time Frame: before discharge ]
  7. Postoperative delirium in recovery room [ Time Frame: within PACU stay ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Wei Mei, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01020201     History of Changes
Other Study ID Numbers: TJHMZK01003
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

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

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