Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery

PHASE4RecruitingINTERVENTIONAL
Enrollment

476

Participants

Timeline

Start Date

March 18, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

December 31, 2026

Conditions
AdultsMajor Noncardiac SurgeryDexmedetomidineEsketaminePostoperative Sleep Disturbances
Interventions
DRUG

Dexmedetomidine-esketamine combination

Dexmedetomidine 0.4 μg/kg and esketamine 0.2 mg/kg is infused over 10 minutes before anesthesia induction. Dexmedetomidine 0.20 μg/kg/h and esketamine 0.10 mg/kg/h is then infused until 60 minutes before the expected end of surgery. Patient-controlled intravenous analgesia is established with 100 μg dexmedetomidine, 50 mg esketamine, and 100 μg sufentanil, diluted to 100 mL with normal saline, and programmed to deliver 2-mL boluses with a lock-out interval of 8 minutes and background infusion rate at 1 mL/h for up to 72 hours after surgery.

DRUG

Placebo

Placebo (normal saline) is administered in the same rate and volume as that in the dexmedetomidine-esketamine group. Patient-controlled intravenous analgesia is established with 100 μg sufentanil, diluted to 100 mL with normal saline, and programmed to deliver 2-mL boluses with a lock-out interval of 8 minutes and background infusion rate at 1 mL/h for up to 72 hours after surgery.

Trial Locations (1)

100034

RECRUITING

Peking University First Hospital, Beijing

All Listed Sponsors
lead

Peking University First Hospital

OTHER