The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study

PHASE4RecruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

June 6, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

February 28, 2026

Conditions
Postoperative FatiguePostoperative Sleep DisturbancesSurgical Stress Response
Interventions
DRUG

Placebo

The comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention.

DRUG

Dexmedetomidine

Nocturnal administration of dexmedetomidine (0.2-1.0 mcg/kg/h) during the first night after surgery. Dexmedetomidine infusion, not preceded by a bolus administration, will be started at 0.4 mcg/kg/h in the intervention group at 8 p.m. the day of surgery. Dexmedetomidine infusion will be titrated every 30 minutes with 0.1 mcg/kg/h steps until a RASS of -1 to -3 (drowsy, light to moderate sedation) is reached. The infusion will be discontinued at 6 a.m. the next morning.

Trial Locations (1)

3600

RECRUITING

Ziekenhuis Oost-Limburg, Genk

All Listed Sponsors
lead

Ziekenhuis Oost-Limburg

OTHER