Combining dexmedetomidine and esketamine for sedation after surgery in older ICU patients

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

This trial will see if giving dexmedetomidine together with esketamine for sedation reduces delirium in older patients recovering in the ICU after surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07151716 on ClinicalTrials.gov

What this trial studies

This interventional Phase 4 trial compares sedation with dexmedetomidine alone versus a dexmedetomidine-esketamine combination in postoperative ICU patients aged 60 and older. Participants will be monitored during their ICU stay for delirium, sleep quality, pain control, duration of mechanical ventilation, length of ICU and hospital stay, and adverse effects. Common exclusions include severe preexisting neurologic disease, significant cardiac instability, high risk of obstructive sleep apnea or BMI >30, and severe liver or renal dysfunction. The study is conducted at Peking University First Hospital in Beijing and aims to determine whether the combination lowers delirium without increasing harms.

Who should consider this trial

Good fit: Adults aged 60 or older admitted to the ICU after surgery who are expected to stay at least one night and do not meet the specified exclusion criteria.

Not a fit: Patients with preexisting severe neurologic disorders, high risk of obstructive sleep apnea or BMI >30, significant cardiac instability, severe liver or renal failure, or inability to communicate are excluded and would not be expected to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could reduce delirium and improve pain and sleep after surgery, possibly shortening mechanical ventilation time and ICU stay.

How similar studies have performed: Recent smaller studies reported improved analgesia and sleep quality with dexmedetomidine-esketamine combinations without increasing side effects, but direct evidence for reducing ICU delirium is still limited.

Eligibility criteria

Inclusion Criteria:

1. Aged 60 years or older;
2. Admitted to the intensive care unit (ICU) after surgery;
3. Expected to stay in the ICU for at least one night.

Exclusion Criteria:

1. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
2. Presence of preoperative delirium, or inability to communicate due to coma, severe dementia, or language barrier;
3. Previously diagnosed obstructive sleep apnea, judged to be at high risk of moderate-to-severe obstructive sleep apnea according to the STOP-Bang questionnaire, or have a body mass index \>30 kg/m²;
4. Preoperative left ventricular ejection fraction \<30%, sick sinus syndrome, severe sinus bradycardia (heart rate \<50 bpm), second-degree or higher atrioventricular block without a pacemaker, or systolic blood pressure \<90 mmHg despite use of vasopressors;
5. Comorbid with hyperthyroidism or pheochromocytoma;
6. Severe liver dysfunction (Child-Pugh Class C), severe renal dysfunction (requiring dialysis), or expected survival ≤24 hours;
7. After traumatic brain injury or neurosurgery;
8. Allergy to dexmedetomidine and/or esketamine;
9. Other conditions that are considered unsuitable for study participation.

Where this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Dong-Xin Wang, MD, PhD

Conditions Older Patients; Postoperative Care; Intensive Care Unit; Dexmedetomidine; Esketamine; Delirium; Older patients; Postoperative care