Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations
Primary Purpose
Cardiac Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dexmedetomidine-remifentanil
midazolam-remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrhythmia focused on measuring cardiac ablation
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
dexmedetomidine-remifentanil
midazolam-remifentanil
Arm Description
intravenous infusion of 0.2-0.7 µg/kg/h of dexmedetomidine after a loading dose of 1 µg/kg over 10 min
remifentanil 3.6-7.2 mcg/kg/h midazolam 1-2mg
Outcomes
Primary Outcome Measures
change of sedation depth
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01652586
Brief Title
Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia
Keywords
cardiac ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine-remifentanil
Arm Type
Experimental
Arm Description
intravenous infusion of 0.2-0.7 µg/kg/h of dexmedetomidine after a loading dose of 1 µg/kg over 10 min
Arm Title
midazolam-remifentanil
Arm Type
Active Comparator
Arm Description
remifentanil 3.6-7.2 mcg/kg/h midazolam 1-2mg
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine-remifentanil
Intervention Type
Drug
Intervention Name(s)
midazolam-remifentanil
Primary Outcome Measure Information:
Title
change of sedation depth
Description
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
Time Frame
5 min after study drug adminstration, and every 10 min thereafter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Lan Kwak, MD, PhD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations
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