Effect of Combination Dexmedetomidine Added to Fentanyl-based Intravenous Patient-controlled Analgesia on Nausea Vomiting in Highly Susceptible Patients Undergoing Lumbar Spinal Surgery: Prospective Double Blinded Randomized Controlled Trial

Not Applicable

Completed

• Conditions: PONV
• Interventions: Drug: dexmedetomidine; Drug: normal saline

• Registration Number: NCT01840254
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	dexmedetomidine	addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA)
normal saline	normal saline	normal saline as a placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of