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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

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ClinicalTrials.gov Identifier: NCT01840254
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
PONV Drug: dexmedetomidine Drug: normal saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : September 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: dexmedetomidine
addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA)
 Drug: dexmedetomidine
Placebo Comparator: normal saline
normal saline as a placebo
 Drug: normal saline


Outcome Measures
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Primary Outcome Measures :
  1. total dose and bolus administration of opioid [ Time Frame: 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 :
  1. consequent postoperative nausea and vomiting [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840254


Locations
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Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01840254     History of Changes
Other Study ID Numbers: 4-2012-0490
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014
Keywords provided by Yonsei University:
PONV
IV PCA
dexmedetomidine
 Female
non-smoking
lumbar spine surgery
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action