Effect of Remimazolam Versus Dexmedetomidine on the Incidence of Delirium After Elective Cardiac Surgery with Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

January 10, 2025

Primary Completion Date

November 1, 2026

Study Completion Date

November 1, 2027

Conditions
Delirium - Postoperative
Interventions
DRUG

Propofol Group 1

"Postoperative Use:~Bolus: 10-20 mg intravenously as needed for sedation initiation. Continuous infusion: 0.3-0.5 mg/kg/hour to maintain light sedation adjusted based on clinical response."

DRUG

Remimazolam Intervention

"Postoperative Use:~Initial bolus: 5 mg intravenously upon ICU arrival. Continuous infusion: 0.2-0.3 mg/kg/hour to maintain light sedation with a maximum dose of 0.8 mg/kg/hour.~Rescue sedation with propofol or midazolam will be allowed if patients become agitated or if Remimazolam is ineffective in maintaining target sedation."

DRUG

Dexmedetomidine Intervention

"Postoperative Use:~Loading dose: 0.5-1 μg/kg over 10-20 minutes after ICU arrival. Continuous infusion: 0.2-0.7 μg/kg/hour for sedation maintenance, adjusted as needed to maintain light sedation.~Rescue sedation with propofol or midazolam will be administered if Dexmedetomidine fails to maintain adequate sedation or if patients become agitated."

Trial Locations (1)

Unknown

Assiut University, Asyut

All Listed Sponsors
lead

Assiut University

OTHER