Actively Recruiting

Phase 4
Age: 60Years +
All Genders
NCT07151716

Sedation With Dexmedetomidine-esketamine Combination and Delirium in ICU Patients

Led by Peking University First Hospital · Updated on 2025-11-25

100

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sedation With Dexmedetomidine-esketamine Combination and Delirium in ICU Patients

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
  • Presence of preoperative delirium, or inability to communicate due to coma, severe dementia, or language barrier
  • Previously diagnosed obstructive sleep apnea, high risk of moderate-to-severe obstructive sleep apnea by STOP-Bang questionnaire, or body mass index over 30 kg/m��
  • Preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (heart rate less than 50 bpm), second-degree or higher atrioventricular block without pacemaker, or systolic blood pressure less than 90 mmHg despite vasopressors
  • Comorbid hyperthyroidism or pheochromocytoma
  • Severe liver dysfunction (Child-Pugh Class C), severe renal dysfunction requiring dialysis, or expected survival 24 hours or less
  • After traumatic brain injury or neurosurgery
  • Allergy to dexmedetomidine and/or esketamine
  • Other conditions considered unsuitable for participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

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Research Team

D

Dong-Xin Wang, MD, PhD

CONTACT

L

Li Mo, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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