Skip to content

Effects of low-dose dexmedetomidine combined with esketamine infusion on sleep in non-mechanical ventilation patients with sepsis in ICU: a multicenter, randomized, double-blind, placebo-controlled study

Effects of low-dose dexmedetomidine combined with esketamine infusion on sleep in non-mechanical ventilation patients with sepsis in ICU: a multicenter, randomized, double-blind, placebo-controlled study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115440
Enrollment
Unknown
Registered
2025-12-26
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

Test group:The initial infusion rate is [0.025×kg]·ml/h (equivalent to 0.05 g/kg/h for dexmedetomidine and 0.025 mg/kg/h for esmolol). Depending on the patients condition, the infusion rate can be inc
Control group:The infusion rate of 0.9% normal saline was the same as that of the test drug.

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Age (>=18 years); 2.Non-mechanical ventilation patients receiving clinical treatment in the ICU at night (after 6pm) for an estimated duration of at least 12h; 3.Meet the diagnostic criteria for sepsis (Sepsis 3.0) (suspected or combined infection and SOFA score >=2);

Exclusion criteria

Exclusion criteria: 1.History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis; 2.Inability to communicate due to coma, delirium, severe dementia or language disorders; 3.Stroke, hypoxic encephalopathy, craniocerebral injury or neurosurgical surgery; 4.Patients with a history of hyperthyroidism and pheochromocytoma; 5.Regular (continuous for more than 1 week) use of sedative/bedtime medication, analgesic within the last month; 6.The current left ventricular ejection fraction (left ventricular ejection fraction, LVEF) is less than 30%, or sick sinoatrial node syndrome, severe sinus bradycardia (heart rate 30kg/m^2; 9.Allergy to dexmedetomidine and/or esketamine; 10.Patients who are not suitable for inclusion after the study doctor evaluates the basic condition; 11.Participate in other clinical studies.

Design outcomes

Primary

MeasureTime frame
N2 sleep percentage;

Secondary

MeasureTime frame
Join the group that eveninchanges in sleep structure, including total sleep time, sleep efficiency, sleep fragmentation index, and the duration and percentage of each sleep stage.;Subjective sleep score ;subjective pain scoring ;delirium occurrence ;SOFA score;arterial blood gas lactate levels, the use and dosage of vasoactive drugs, IL-6 and hs-CRP were measured once daily at 20:00.;Non-mechanical ventilation time, mechanical ventilation time (for intubated patients), and ICU stay time.;

Countries

China

Contacts

Public ContactLi Shuangling

The First Hospital of Peking University

lishuangling888@hotmail.com+86 136 6135 5069

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026