Clinical trial NCT01020201: Risk Factors for Post Operative Nausea and Vomiting(PONV) in Patients Underwent Gynecological Operation Under General Anesthesia
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Elective Gynecological Operation
Chinese Female Patient
Adult
Keywords: Anesthesia, General
Elective Gynecological Operation
Chinese female patient
Adult
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 774
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients underwent gynecological operation under general anesthesia between 2009.02 and 2009.05.

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.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Chinese female patient

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: within 24 postoperative hours
Secondary outcomes:
measure: Incidence of postoperative shivering
timeFrame: within 24 postoperative hours
measure: Postoperative pain score with Numerical Rating Scale (NRS-11)
timeFrame: within 24 postoperative hours
measure: Time to full recovery of intestinal function
timeFrame: within 24 postoperative hours
measure: Preoperative and postoperative fasting time
timeFrame: within 24 postoperative hours
measure: Length of postoperative hospital stay and Length of hospital stay
timeFrame: before discharge
measure: Total health care costs
timeFrame: before discharge
measure: Postoperative delirium in recovery room
timeFrame: within PACU stay
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Yuke Tian, M.D., PhD.
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Wei Mei, M.D.
role: STUDY_DIRECTOR
References: