Effect of Sedation With Dexmedetomidine-esketamine Combination on Delirium in Postoperative ICU Patients: a Randomized Controlled Pilot Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Patients in the intensive care unit (ICU) often develop anxiety and agitation, sleep disturbances, and delirium. Delirium occurrence is associated with worse early and long-term outcomes. Dexmedetomidine and ketamine are recommended for sedation and analgesia in postoperative ICU patients, but each may induce side effects. The sedative effects of dexmedetomidine can help mitigate the neuropsychiatric side effects of esketamine. Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing side effects. This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in postoperative ICU patients may reduce delirium.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Aged 60 years or older;

• Admitted to the intensive care unit (ICU) after surgery;

• Expected to stay in the ICU for at least one night.

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Dong-Xin Wang, MD, PhD
wangdongxin@hotmail.com
8610 83572784
Backup
Li Mo, MD, PhD
mzlm@pku.edu.cn
8610 83575138
Time Frame
Start Date: 2025-10-21
Estimated Completion Date: 2026-10
Participants
Target number of participants: 100
Treatments
Active_comparator: Dexmedetomidine
Sedation is provided with dexmedetomidine (4 μg/ml dexmedetomidine) for up to 7 days or until discharge from the ICU.
Experimental: Dexmedetomidine-esketamine combination
Sedation is provided with dexmedetomidine-esketamine combination (2 μg/ml dexmedetomidine and 1 mg/ml esketamine) combination for up to 7 days or until discharge from the ICU.
Related Therapeutic Areas
Sponsors
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov