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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yonsei University

ClinicalTrials.gov Identifier:

NCT01652586

First received: July 23, 2012

Last updated: July 27, 2012

Last verified: July 2012

History of Changes

Purpose

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	Intervention
Cardiac Arrhythmia	Drug: dexmedetomidine-remifentanil Drug: midazolam-remifentanil


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Midazolam maleate Midazolam hydrochloride Dexmedetomidine Remifentanil hydrochloride Dexmedetomidine hydrochloride

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

change of sedation depth [ Time Frame: 5 min after study drug adminstration, and every 10 min thereafter ] [ Designated as safety issue: No ]
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


Enrollment:	90
Study Start Date:	April 2011
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01652586

Sponsors and Collaborators

Yonsei University

Investigators


Principal Investigator:	Young Lan Kwak, MD, PhD	Severance Hospital

More Information


Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT01652586 History of Changes
Other Study ID Numbers:	1-2011-0008
Study First Received:	July 23, 2012
Last Updated:	July 27, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:


cardiac ablation

Additional relevant MeSH terms:


Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Remifentanil Midazolam Dexmedetomidine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives	Anesthetics, Intravenous Anesthetics, General Anesthetics Adjuvants, Anesthesia Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Non-Narcotic Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists

ClinicalTrials.gov processed this record on September 30, 2016

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