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

Yonsei University

Status: Completed

Conditions: Cardiac Arrhythmia

Treatments: Drug: midazolam-remifentanil; Drug: dexmedetomidine-remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01652586

1-2011-0008

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

dexmedetomidine-remifentanil

Experimental group

Description:

intravenous infusion of 0.2-0.7 µg/kg/h of dexmedetomidine after a loading dose of 1 µg/kg over 10 min

Treatment:

Drug: dexmedetomidine-remifentanil

midazolam-remifentanil

Active Comparator group

Description:

remifentanil 3.6-7.2 mcg/kg/h midazolam 1-2mg

Treatment:

Drug: midazolam-remifentanil