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NCT Number: NCT05718024

Night-time Dexmedetomidine-esketamine Infusion and Sleep Quality in ICU Patients

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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Key information

Conditions

Intensive Care Unit Dexmedetomidine Dyssomnias Esketamine Mechanical Ventilation Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Dexmedetomidine-esketamine

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.

Routine sedation and analgesia

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).

Primary outcomes

  1. Percentage of non-rapid eye movement sleep stage 2

    Time frame: From 21:00 pm to next 6:00 am during the first night after recruitment

    Polysomnographic monitoring is performed during the first night after recruitment with an EEG/PSG Recording System (SOMNO screen plus, SOMNO medics GmbH, Randersacker, Germany). The monitored sleep architecture is divided into wakefulness, non-rapid eye movement (stages N1, N2, and N3) sleep, and rapid eye movement (REM) sleep. The percentages of each sleep stage are calculated as the durations of each sleep stage divided by the total sleep time.

Secondary outcomes

  1. Total sleep time

    Time frame: From 21:00 pm to next 6:00 am during the first night after enrollment

    Polysomnographic monitoring is performed during the first night after recruitment with an EEG/PSG Recording System (SOMNO screen plus, SOMNO medics GmbH, Randersacker, Germany). Total sleep time is defined as the summary of time spent in any sleep stage during the monitoring period.

  2. Sleep efficiency

    Time frame: From 21:00 pm to next 6:00 am during the first night after enrollment

    Polysomnographic monitoring is performed during the first night after recruitment with an EEG/PSG Recording System (SOMNO screen plus, SOMNO medics GmbH, Randersacker, Germany). Sleep efficiency is calculated as the summary of time spent in each sleep stage divided by total sleep monitoring time.

  3. Sleep fragmentation index

    Time frame: From 21:00 pm to next 6:00 am during the first night after enrollment

    Polysomnographic monitoring is performed during the first night after recruitment with an EEG/PSG Recording System (SOMNO screen plus, SOMNO medics GmbH, Randersacker, Germany). Sleep fragmentation index is calculated as the total number of awakenings and sleep-stage shifts divided by total sleep time.

  4. Time of sleep in each stage

    Time frame: From 21:00 pm to next 6:00 am during the first night after enrollment

    Polysomnographic monitoring is performed during the first night after recruitment with an EEG/PSG Recording System (SOMNO screen plus, SOMNO medics GmbH, Randersacker, Germany). The monitored sleep architecture is divided into wakefulness, non-rapid eye movement (stages N1, N2, and N3) sleep, and rapid eye movement (REM) sleep.

  5. Percentage of sleep in each stage (except percentage of non-rapid eye movement sleep stage 2)

    Time frame: From 21:00 pm to next 6:00 am during the first night after enrollment

    Polysomnographic monitoring is performed during the first night after recruitment with an EEG/PSG Recording System (SOMNO screen plus, SOMNO medics GmbH, Randersacker, Germany). The monitored sleep architecture is divided into wakefulness, non-rapid eye movement (stages N1, N2, and N3) sleep, and rapid eye movement (REM) sleep. The percentages of each sleep stage are calculated as the durations of each sleep stage divided by the total sleep time.

  6. Pain intensity

    Time frame: During the first 5 days after enrollment

    Pain intensity is assessed twice daily (8:00 am to 10:00 am and 6:00 pm to 8:00 pm) with the numeric rating scale where 0=no pain and 10=the worst pain.

  7. Subjective sleep quality

    Time frame: During the first 5 days after enrollment

    Subjective sleep quality is assessed daily (8:00 am to 10:00 am) with the numeric rating scale where 0=the best sleep and 10=the worst sleep.

  8. Sedation-agitation level

    Time frame: During the first 5 days after enrollment

    Sedation-agitation level is assessed twice daily (8:00 am to 10:00 am and 6:00 pm to 8:00 pm) with the Richmond Agitation Sedation Scale; score ranges from -5 (unarousable) to +4 (combative) and 0 indicates alert and calm.

  9. Delirium occurrence

    Time frame: During the first 5 days after enrollment

    Delirium is assessed twice daily (8:00 am to 10:00 am and 6:00 pm to 8:00 pm) with the Confusion Assessment Method for the ICU.

  10. Duration of mechanical ventilation

    Time frame: Up to 30 days after enrollment

    Mechanical ventilation during ICU stay.

  11. Length of ICU stay

    Time frame: Up to 30 days after enrollment

    Length of ICU stay.

Other outcomes

  1. Length of hospital stay

    Time frame: Up to 30 days after enrollment

    Length of hospital stay.

  2. Incidence of complications within 30 days

    Time frame: Up to 30 days after enrollment

    Complications are defined as new-onset medical conditions other than delirium that were deemed harmful and required therapeutic intervention, i.e., grade II or higher on the Clavien-Dindo classification.

  3. All-cause mortality within 30 days

    Time frame: Up to 30 days after enrollment

    All-cause mortality within 30 days

  4. Subjective sleep quality at 30 days

    Time frame: At 30 days after enrollment

    Subjective sleep quality is assessed with the Pittsburgh sleep quality index (PSQI). The PSQI consists of 19 self-rated and 5 other-rated items used to assess sleep quality over a month.

  5. Quality of life at 30 days in physical domain

    Time frame: At 30 days after enrollment

    Quality of life is assessed with the World Health Organization Quality of Life-brief version (WHOQOL-BREF; a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, and social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function).

  6. Quality of life at 30 days in psychological domain

    Time frame: At 30 days after enrollment

    Quality of life is assessed with the World Health Organization Quality of Life-brief version (WHOQOL-BREF; a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, and social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function).

  7. Quality of life at 30 days in social relationship domain

    Time frame: At 30 days after enrollment

    Quality of life is assessed with the World Health Organization Quality of Life-brief version (WHOQOL-BREF; a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, and social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function).

  8. Quality of life at 30 days in environmental domain

    Time frame: At 30 days after enrollment

    Quality of life is assessed with the World Health Organization Quality of Life-brief version (WHOQOL-BREF; a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, and social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function).

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Impact of Night-time Dexmedetomidine-esketamine Infusion on Sleep Quality of Patients With Mechanical Ventilation or High-flow Nasal Cannula Oxygen Therapy in ICU: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2023
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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