NCT Number: NCT01652586
Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations
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.
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Notify MeKey information
Conditions
Age range
20 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
midazolam-remifentanil
DrugPrimary outcomes
-
change of sedation depth
Time frame: 5 min after study drug adminstration, and every 10 min thereafter
- 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
Sponsors and collaborators
Lead sponsor
Yonsei University
Other
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Jul 30, 2012
- Registry last updated
- Jul 30, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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