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

Cardiac Arrhythmia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652586
• Other study ID #: 1-2011-0008
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: July 27, 2012
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Drug:
• dexmedetomidine-remifentanil

• midazolam-remifentanil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 min after study drug adminstration, and every 10 min thereafter	No