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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01840254
Other study ID # 4-2012-0490
Secondary ID
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


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
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