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

July 23, 2012
July 27, 2012
April 2011
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01652586 on ClinicalTrials.gov Archive Site
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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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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cardiac Arrhythmia
  • Drug: dexmedetomidine-remifentanil
  • Drug: midazolam-remifentanil
  • 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
    Intervention: Drug: dexmedetomidine-remifentanil
  • Active Comparator: midazolam-remifentanil
    remifentanil 3.6-7.2 mcg/kg/h midazolam 1-2mg
    Intervention: Drug: midazolam-remifentanil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01652586
1-2011-0008
No
Yonsei University
Yonsei University
Not Provided
Principal Investigator: Young Lan Kwak, MD, PhD Severance Hospital
Yonsei University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP