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Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations

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ClinicalTrials.gov Identifier: NCT01652586
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:
Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are associated with respiratory depression and hypotension. The aim of this study was to compare the effect of remifentanil and dexmedetomidine, which exerts sedative and analgesic effect without serious respiratory depression, with conventional midazolam/remifentanil combination on sedative and analgesic levels in patients undergoing endocardial ablation.

Condition or disease Intervention/treatment Phase
Cardiac Arrhythmia Drug: dexmedetomidine-remifentanil Drug: midazolam-remifentanil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: dexmedetomidine-remifentanil
intravenous infusion of 0.2-0.7 µg/kg/h of dexmedetomidine after a loading dose of 1 µg/kg over 10 min
 Drug: dexmedetomidine-remifentanil
Active Comparator: midazolam-remifentanil
remifentanil 3.6-7.2 mcg/kg/h midazolam 1-2mg
 Drug: midazolam-remifentanil


Outcome Measures
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Primary Outcome Measures :
  1. change of sedation depth [ Time Frame: 5 min after study drug adminstration, and every 10 min thereafter ]
    1. Ramsay sedation score (1 = anxious and agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responsive to verbal commands, drowsy; 4 = asleep, responsive to light stimulation; 5 = asleep, slow response to stimulation; 6 = no response to stimulation)
    2. the bispectral index


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for elective cardiac ablation for atrial fibrillation

Exclusion Criteria:

  • ASA physical status class ≥ 3,
  • respiratory disease,
  • end stage renal disease,
  • illiterate
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): NCT01652586


Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Young Lan Kwak, MD, PhD Severance Hospital
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01652586     History of Changes
Other Study ID Numbers: 1-2011-0008
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by Yonsei University:
cardiac ablation

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dexmedetomidine
Midazolam
Remifentanil
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
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Analgesics, Opioid