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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01652586

Enrollment

Registered

2012-07-30

Start date

2011-04-30

Completion date

2011-12-31

Last updated

2012-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia

Keywords

cardiac ablation

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.

Interventions

DRUGdexmedetomidine-remifentanil

DRUGmidazolam-remifentanil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026