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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

ClinicalTrials.gov processed this record on July 21, 2016