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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
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrhythmia focused on measuring cardiac ablation

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 23, 2012
    Last Updated
    July 27, 2012
    Sponsor
    Yonsei University
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    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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