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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01652586
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : July 30, 2012
Information provided by (Responsible Party):
Yonsei University

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 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

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

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

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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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01652586

Sponsors and Collaborators
Yonsei University
Principal Investigator: Young Lan Kwak, MD, PhD Severance Hospital

Responsible Party: Yonsei University 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
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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
GABA Modulators
GABA Agents
Analgesics, Opioid