Dexmedetomidine and Remifentanil in NORA
- Conditions
- Comparison of the Effects of Remifentanil and Dexmedetomidine
- Interventions
- Registration Number
- NCT06403670
- Lead Sponsor
- Baskent University Ankara Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
-ASA 1-3
- Neurological disease,
- Psychiatric disease,
- Coronary artery disease,
- Long-term sedative drug use,
- Pregnant patients,
- Known allergy to planned drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group Remi Remifentanil Group RP received remifentanil 0.1 mcg/kg intravenously for 2 minutes, 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. Group Dex Dexmedetomidine Group Dex received 0.5 mcg/kg of dexmedetomidine IV for 10 minutes, 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.
- Primary Outcome Measures
Name Time Method Agitation-Sedation 0 and 5 minutes after ERCP ends It will be evaluated with a Richmond Agitation-Sedation Scale.
Hemodynamic stability 5, 10, 15, 25, 35. minutes Mean arterial pressure with non-invasive blood pressure monitoring (mmHg)
- Secondary Outcome Measures
Name Time Method Minimize drug dose 5, 10, 15, 25, 35. minutes Amounts of medication administered throughout the procedure period will be collected.
Rapid recovery 30 minutes after ERCP ends It will be evaluated with a Modified Aldrete Score.
Patient comfort 30 minutes after ERCP ends It will be evaluated by nausea-vomiting and survey.
Trial Locations
- Locations (1)
Baskent University Ankara Hospital
🇹🇷Ankara, Cankaya, Turkey