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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Percentage of non-rapid eye movement sleep stage 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dexmedetomidine-esketamine (Drug)
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.
干预措施: Routine sedation and analgesia (Drug)
结局指标
主要结局
Percentage of non-rapid eye movement sleep stage 2
时间窗: 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.
次要结局
- Sleep efficiency(From 21:00 pm to next 6:00 am during the first night after enrollment)
- Sedation-agitation level(During the first 5 days after enrollment)
- Total sleep time(From 21:00 pm to next 6:00 am during the first night after enrollment)
- Sleep fragmentation index(From 21:00 pm to next 6:00 am during the first night after enrollment)
- Time of sleep in each stage(From 21:00 pm to next 6:00 am during the first night after enrollment)
- Percentage of sleep in each stage (except percentage of non-rapid eye movement sleep stage 2)(From 21:00 pm to next 6:00 am during the first night after enrollment)
- Pain intensity(During the first 5 days after enrollment)
- Subjective sleep quality(During the first 5 days after enrollment)
- Delirium occurrence(During the first 5 days after enrollment)
- Duration of mechanical ventilation(Up to 30 days after enrollment)
- Length of ICU stay(Up to 30 days after enrollment)
研究者
Dong-Xin Wang
Professor, Chief Physician
Peking University First Hospital