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

Anesthesia, General Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020201
• Other study ID #: TJHMZK01003
• Status: Completed
• Phase: N/A
• First received: November 24, 2009
• Last updated: July 30, 2012
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: July 2012
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health Department of Hubei Province
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 774
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old

• Chinese female patient

Exclusion Criteria:

• Unstable vital sign

• Patients under mechanical ventilation

• Patients under sedition (RASS=<-2)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adult
• Anesthesia, General
• Chinese Female Patient
• Elective Gynecological Operation
• Postoperative Nausea and Vomiting

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative nausea and vomiting		within 24 postoperative hours	Yes
Secondary	Incidence of postoperative shivering		within 24 postoperative hours	No
Secondary	Postoperative pain score with Numerical Rating Scale (NRS-11)		within 24 postoperative hours	No
Secondary	Time to full recovery of intestinal function		within 24 postoperative hours	No
Secondary	Preoperative and postoperative fasting time		within 24 postoperative hours	No
Secondary	Length of postoperative hospital stay and Length of hospital stay		before discharge	No
Secondary	Total health care costs		before discharge	No
Secondary	Postoperative delirium in recovery room		within PACU stay	No