NCT06403670

Dexmedetomidine and Remifentanil in NORA

The Effects of Dexmedetomidine and Remifentanil on Sedation and Comfort in Non-Operating Room Anesthesia: A Randomized, Double-blind, Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Baskent University Ankara Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) procedure is frequently encountered in non-operating room anesthesia applications (NORA). It is a procedure that requires deep sedation and analgesia in terms of gastroenterologist and patient comfort. Dexmedetomidine, which is increasingly used in NORA applications, comes to the fore because it does not cause respiratory depression, reduces the stress response, and provides hemodynamic stability. This study aims to compare the effects of dexmedetomidine-propofol (DP) and remifentanil-propofol (RP) combinations on hemodynamic stability, rapid recovery, and patient comfort in patients who underwent ERCP.

Conditions

• Comparison of the Effects of Remifentanil and Dexmedetomidine

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Group DP received 0.5 mcg/kg of dexmedetomidine IV for 30 seconds, then dexmedetomidine infusion was started at 0.1-0.7 mcg/kg/h. Propofol 1 mg/kg was administered after waiting for 5 minutes for adequate sedation to develop due to dexmedetomidine's delayed onset of action.
DRUG	Remifentanil	Group RP received remifentanil 0.1 mcg/kg intravenously for 30 seconds, then remifentanil infusion was started at 0.01-0.1 mcg/kg/min. After waiting 2 minutes to develop a sufficient sedation level, 1 mg/kg of propofol was given.

Timeline

• Start date: 2022-12-17
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2024-05-08
• Last updated: 2024-05-08

Locations

1 site across 1 country: Turkey (Türkiye)