Night-time Dexmedetomidine-esketamine Infusion and Sleep Quality in ICU Patients
NCT ID: NCT05718024
Last Updated: 2025-12-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
174 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-11-01
Study Completion Date
2025-05-23
Brief Summary
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Dexmedetomidine and ketamine are both suggested for sedation and analgesia in ICU patients. Recent studies suggest that low-dose dexmedetomidine or ketamine/esketamine may improve sleep quality of ICU patients. The purpose of this trial is to observe whether night-time infusion of low-dose dexmedetomidine-esketamine combination can improve sleep structure of patients receiving mechanical ventilation or high-flow nasal cannula oxygen therapy in the ICU.
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Detailed Description
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Sleep disturbances are common in patients during intensive care unit (ICU) stay, especially those receiving mechanical ventilation. Persistent sleep disturbances are associated with negative outcomes, including increased sensitivity to pain, increased risk of delirium and cardiovascular events, and delayed weaning from mechanical ventilation.
Dexmedetomidine and ketamine are both suggested for sedation and analgesia in ICU patients. Previous studies showed that night-time dexmedetomidine infusion may improve sleep quality in ICU patients with mechanical ventilation, the effect is dose-dependent. However, sedative dose dexmedetomidine increases adverse events inculding bradycardia and hypotension. Recent studies suggest that ketamine/esketamine may also improve sleep quality. But even low-dose ketamine/esketamine increases adverse events including psychiatric and dissociative symptoms. We suppose that combined use of low-dose dexmedetomidine and esketamine may produce synergic effects in improving sleep quality in ICU patients with less adverse events.
The purpose of this trial is to observe whether night-time infusion of low-dose dexmedetomidine-esketamine combination can improve sleep structure of patients receiving mechanical ventilation or high-flow nasal cannula oxygen therapy in ICU patients and the safety of this regimen.
Dexmedetomidine and ketamine are both suggested for sedation and analgesia in ICU patients. Previous studies showed that night-time dexmedetomidine infusion may improve sleep quality in ICU patients with mechanical ventilation, the effect is dose-dependent. However, sedative dose dexmedetomidine increases adverse events inculding bradycardia and hypotension. Recent studies suggest that ketamine/esketamine may also improve sleep quality. But even low-dose ketamine/esketamine increases adverse events including psychiatric and dissociative symptoms. We suppose that combined use of low-dose dexmedetomidine and esketamine may produce synergic effects in improving sleep quality in ICU patients with less adverse events.
The purpose of this trial is to observe whether night-time infusion of low-dose dexmedetomidine-esketamine combination can improve sleep structure of patients receiving mechanical ventilation or high-flow nasal cannula oxygen therapy in ICU patients and the safety of this regimen.
Conditions
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Intensive Care Unit
Mechanical Ventilation
Dexmedetomidine
Esketamine
Sleep Quality
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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Dexmedetomidine-esketamine
Dexmedetomidine-esketamine combination will be infused during night-time (8 pm to 6:30 am) for ICU patients with mechanical ventilation or high-flow nasal cannula oxygen therapy, for a duration of up to 5 days.
Group Type
EXPERIMENTAL
Dexmedetomidine-esketamine
Intervention Type
DRUG
Dexmedetomidine-esketamine combination will be infused during night-time (8 pm to 6:30 am) for ICU patients with mechanical ventilation or high-flow nasal cannula oxygen therapy.
Control
Propofol and remifentanil will be infused during night-time (8 pm to 6:30 am) for ICU patients with mechanical ventilation or high-flow nasal cannula oxygen therapy (if necessary), for a duration of up to 5 days.
Group Type
ACTIVE_COMPARATOR
Routine sedation and analgesia
Intervention Type
DRUG
Propofol and remifentanil will be infused during night-time (8 pm to 6:30 am) for ICU patients with mechanical ventilation or high-flow nasal cannula oxygen therapy (if necessary).
Interventions
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Dexmedetomidine-esketamine
Dexmedetomidine-esketamine combination will be infused during night-time (8 pm to 6:30 am) for ICU patients with mechanical ventilation or high-flow nasal cannula oxygen therapy.
Intervention Type
DRUG
Routine sedation and analgesia
Propofol and remifentanil will be infused during night-time (8 pm to 6:30 am) for ICU patients with mechanical ventilation or high-flow nasal cannula oxygen therapy (if necessary).
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Aged 50 years or older;
* Admitted to the intensive care unit (ICU) after surgery;
* Receiving mechanical ventilation or high-flow nasal cannula oxygen therapy during night-time (after 6 pm), with an expected duration of ≥12 hours.
* Admitted to the intensive care unit (ICU) after surgery;
* Receiving mechanical ventilation or high-flow nasal cannula oxygen therapy during night-time (after 6 pm), with an expected duration of ≥12 hours.
Exclusion Criteria
* Duration of invasive/non-invasive ventilation ≥12 hours before enrollment;
* Planning to receive muscle relaxant treatment;
* History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
* Unable to communicate due to coma, delirium, severe dementia, or language barrier before receiving mechanical ventilation or high-flow nasal cannula oxygen therapy;
* Acute stroke or hypoxic encephalopathy, or after craniocerebral injury or neurosurgery;
* Comorbid with hyperthyroidism or pheochromocytoma;
* Taking sedative/hypnotic drugs or analgesics regularly (for more than 1 week) in the last month;
* LVEF\<30%; sick sinus syndrome, severe sinus bradycardia (heart rate\<50 beats/min), atrioventricular block of more than II degree and without pacemaker; or systolic blood pressure \<90 mmHg despite vasopressor infusion;
* Severe liver dysfunction (Child-Pugh C grade), severe renal dysfunction (dialysis), or estimated survival ≤24 hours;
* Diagnosed obstructive sleep apnea, or body mass index \>30 kg/m2;
* Allergies to dexmedetomidine and/or esketamine, or other conditions that are considered unsuitable for study participation;
* Enrolled in other clinical studies.
* Planning to receive muscle relaxant treatment;
* History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
* Unable to communicate due to coma, delirium, severe dementia, or language barrier before receiving mechanical ventilation or high-flow nasal cannula oxygen therapy;
* Acute stroke or hypoxic encephalopathy, or after craniocerebral injury or neurosurgery;
* Comorbid with hyperthyroidism or pheochromocytoma;
* Taking sedative/hypnotic drugs or analgesics regularly (for more than 1 week) in the last month;
* LVEF\<30%; sick sinus syndrome, severe sinus bradycardia (heart rate\<50 beats/min), atrioventricular block of more than II degree and without pacemaker; or systolic blood pressure \<90 mmHg despite vasopressor infusion;
* Severe liver dysfunction (Child-Pugh C grade), severe renal dysfunction (dialysis), or estimated survival ≤24 hours;
* Diagnosed obstructive sleep apnea, or body mass index \>30 kg/m2;
* Allergies to dexmedetomidine and/or esketamine, or other conditions that are considered unsuitable for study participation;
* Enrolled in other clinical studies.
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Peking University First Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Dong-Xin Wang
Professor, Chief Physician
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Site Status
Countries
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China
References
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Other Identifiers
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2023-006
Identifier Type: -
Identifier Source: org_study_id
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