Comparison of the Effects of Remifentanil and Dexmedetomidine
Conditions
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.
Interventions
DRUGDexmedetomidine
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.
DRUGRemifentanil
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.
Sponsors
Baskent University Ankara Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-ASA 1-3
Exclusion criteria
* Neurological disease, * Psychiatric disease, * Coronary artery disease, * Long-term sedative drug use, * Pregnant patients, * Known allergy to planned drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patient comfort | 30 minutes after ERCP ends | It will be evaluated by nausea-vomiting and survey. |
| Rapid recovery | 30 minutes after ERCP ends | It will be evaluated with a Modified Aldrete Score. |
| Minimize drug dose | 5, 10, 15, 25, 35. minutes | Amounts of medication administered throughout the procedure period will be collected. |
Countries
Turkey (Türkiye)
Outcome results
None listed