Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations

Not Applicable

Completed

• Conditions: Cardiac Arrhythmia
• Interventions: Drug: dexmedetomidine-remifentanil; Drug: midazolam-remifentanil

• Registration Number: NCT01652586
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-07
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-27
• Last Update Submitted: 2012-07-27
• Study First Posted: 2012-07-30
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine-remifentanil	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
midazolam-remifentanil	midazolam-remifentanil	remifentanil 3.6-7.2 mcg/kg/h midazolam 1-2mg

Primary Outcome Measures

Name	Time	Method
change of sedation depth	5 min after study drug adminstration, and every 10 min thereafter	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