PONV
Conditions
Keywords
PONV, IV PCA, dexmedetomidine, Female, non-smoking, lumbar spine surgery
Brief summary
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.
Interventions
DRUGdexmedetomidine
DRUGnormal saline
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total dose and bolus administration of opioid | an expected average of 48 hrs for requirements of total dose and number of bolus administration of PCA | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| consequent postoperative nausea and vomiting | an expected average of 48 hrs for assessing of the 11-points verbal numerical rating scales | 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. |
Countries
South Korea
Outcome results
None listed