Dexmedetomidine and Remifentanil in NORA

Baskent University Ankara Hospital

Status and phase: Completed; Phase 4

Conditions: Comparison of the Effects of Remifentanil and Dexmedetomidine

Treatments: Drug: Dexmedetomidine; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT06403670

NORADEX

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Group Dex

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Group Remi

Active Comparator group

Description:

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.

Treatment:

Drug: Remifentanil