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
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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
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Drug: midazolam-remifentanil |
- change of sedation depth [ Time Frame: 5 min after study drug adminstration, and every 10 min thereafter ]
- 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)
- the bispectral index

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Ages Eligible for Study: | 20 Years to 70 Years (Adult, Senior) |
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

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