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

NCT ID: NCT01840254

Last Updated: 2014-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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PONV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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dexmedetomidine

addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA)

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

normal saline

normal saline as a placebo

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Interventions

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dexmedetomidine

Intervention Type DRUG

normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University College of Medicine

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Song Y, Shim JK, Song JW, Kim EK, Kwak YL. Dexmedetomidine added to an opioid-based analgesic regimen for the prevention of postoperative nausea and vomiting in highly susceptible patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Feb;33(2):75-83. doi: 10.1097/EJA.0000000000000327.

Reference Type DERIVED
PMID: 26258655 (View on PubMed)

Other Identifiers

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4-2012-0490

Identifier Type: -

Identifier Source: org_study_id

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