Sedation With Dexmedetomidine-esketamine Combination and Delirium in ICU Patients

NCT07151716 | Recruiting Phase 4

• 1 other identifier: 2025R069
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Older Patients; Postoperative Care; Intensive Care Unit; Dexmedetomidine; Esketamine; Delirium

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium within 7 days

  Delirium will be assessed twice daily (8:00-10:00, 18:00-20:00) for 7 days or until hospital discharge. Patients with endotracheal intubation will be assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Patients without endotracheal intubation will be assessed with the 3-Minute Diagnostic Assessment for Delirium using the Confusion Assessment Method (3D-CAM). Positive result of delirium assessments at any timepoint is defined as occurrence of delirium.

  Up to 7 days after surgery

Secondary Outcomes (4)

• Total sleep time (TST) on the first postoperative night

  From 20:00 on the night of surgery to 06:00 the next morning

• Postoperative pain score within 7 days

  Up to 7 days after surgery

• Postoperative subjective sleep quality within 7 days

  Up to 7 days after surgery

• Length of stay in the ICU

  Up to 30 days after surgery

Other Outcomes (12)

• Length of stay in hospital after surgery

  Up to 30 days after surgery

• Incidence of major complications within 30 days

  Up to 30 days after surgery

• Incidence of cognitive dysfunction at 30 days

  At 30 days after surgery

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Sedation is provided with dexmedetomidine (4 μg/ml dexmedetomidine) for up to 7 days or until discharge from the ICU.

Drug: Dexmedetomidine

Dexmedetomidine-esketamine combination

EXPERIMENTAL

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.

Drug: Dexmedetomidine-esketamine combination

Interventions

Dexmedetomidine DRUG

For patients with endotracheal intubation, nighttime (20:00-06:00) sedation is initiated with 0.2 μg/kg/h dexmedetomidine and increased/decreased by 0.1 μg/kg/h dexmedetomidine every 15 min, until the Richmond Agitation-Sedation Scale (RASS) reaches -2 to -1, maximal infusion rate reaches 0.7 μg/kg/h dexmedetomidine, or adverse reactions occur. Daytime (06:00-20:00) sedation is provided as above when considered necessary, with a target RASS score of -2 to +1. For patients without endotracheal intubation, nighttime (20:00-06:00) sedation is initiated with 0.10 μg/kg/h dexmedetomidine and increased/decreased by 0.05 μg/kg/h dexmedetomidine every 15 min, until the RASS reaches -1, maximal infusion rate reaches 0.2 μg/kg/h dexmedetomidine, or adverse reactions occur. Daytime (06:00-20:00) sedation is typically not provided.

Also known as: Sedation with dexmedetomidine

Dexmedetomidine

Dexmedetomidine-esketamine combination DRUG

For patients with endotracheal intubation, nighttime (20:00-06:00) sedation is initiated with 0.1 μg/kg/h dexmedetomidine and 0.05 mg/kg/h esketamine, increased/decreased by 0.05 μg/kg/h dexmedetomidine and 0.025 mg/kg/h esketamine every 15 min, until the RASS reaches -2 to -1, maximal infusion rate reaches 0.35 μg/kg/h dexmedetomidine and 0.175 mg/kg/h esketamine, or adverse reactions occur. Daytime (06:00-20:00) sedation is provided as above when considered necessary, with a target RASS score of -2 to +1. For patients without endotracheal intubation, nighttime (20:00-06:00) sedation is initiated with 0.05 μg/kg/h dexmedetomidine and 0.025 mg/kg/h esketamine, and increased/decreased by 0.025 μg/kg/h dexmedetomidine and 0.0125 mg/kg/h esketamine every 15 min, until the RASS reaches -1, maximal infusion rate reaches 0.1 μg/kg/h dexmedetomidine and 0.05 mg/kg/h esketamine, or adverse reactions occur. Daytime (06:00-20:00) sedation is typically not provided.

Also known as: Sedation with dexmedetomidine-esketamine combination

Dexmedetomidine-esketamine combination

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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, 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;
• 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;
• Comorbid with hyperthyroidism or pheochromocytoma;
• Severe liver dysfunction (Child-Pugh Class C), severe renal dysfunction (requiring dialysis), or expected survival ≤24 hours;
• After traumatic brain injury or neurosurgery;
• Allergy to dexmedetomidine and/or esketamine;
• Other conditions that are considered unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

8610 83572784; wangdongxin@hotmail.com

Li Mo, MD, PhD

CONTACT

8610 83575138; mzlm@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)