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

PONV Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840254
• Other study ID #: 4-2012-0490
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: February 5, 2014
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• PONV

Intervention

Drug:
• dexmedetomidine

• normal saline

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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