Risk Factors for Post Operative Nausea and Vomiting(PONV) in Patients Underwent Gynecological Operation Under General Anesthesia
This study has been completed.
Sponsor:
Huazhong University of Science and Technology
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
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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:
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 (Adult, Senior) |
| 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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01020201
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
| 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:
|
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 |
ClinicalTrials.gov processed this record on September 30, 2016