PONV Clinical Trial
Verified date | February 2014 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
The aim of this study is to test the hypothesis that addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of fentanyl bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing lumbar spine surgery.
Status | Completed |
Enrollment | 108 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. female, non-smoking patient who are 20-65 of age scheduled for elective lumbar spine surgery Exclusion Criteria: 1. Bradycardia on EKG (45bpm) 2. Atrioventricular conduction disorder 3. Uncontrolled hypertension 4. angina history 5. obesity (BMI = 30 kg/m2) 6. Preoperative administration of opioid 7. Preoperative administration of antiemetics 8. Gastrointestinal disorder history 9. Hepatic or renal disease 10. Pregnant 11. Foreigner |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | total dose and bolus administration of opioid | After induction of anesthesia, peak velocity of carotid artery blood flow is measured by the pulsed wave Doppler signal obtained from the left common carotid artery. Respirophasic variation of the peak velocity is defined as the difference between the maximum and the minimum values of peak velocity divided by the mean of the two values during one respiratory cycle. Fluid responder is defined as a patient whose stroke volume index is increased =15% after volume expansion. The receiver operating characteristic curve analysis to discriminiate fludi responder is performed. | an expected average of 48 hrs for requirements of total dose and number of bolus administration of PCA | No |
Secondary | consequent postoperative nausea and vomiting | After induction of anesthesia, peak velocity of carotid artery blood flow is measured by the pulsed wave Doppler signal obtained from the left common carotid artery. Respirophasic variation of the peak velocity is defined as the difference between the maximum and the minimum values of peak velocity divided by the mean of the two values during one respiratory cycle. Fluid responder is defined as a patient whose stroke volume index is increased =15% after volume expansion. The receiver operating characteristic curve analysis to discriminate fluid responder is performed. | an expected average of 48 hrs for assessing of the 11-points verbal numerical rating scales | No |
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