Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA
- Conditions
- Obstructive Sleep ApneaSurgeryDexmedetomidineEsketaminePostoperative Sleep Quality
- Interventions
- Drug: Dexmedetomidine-esketamine combinationDrug: Placebo
- Registration Number
- NCT06566482
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
Patients with obstructive sleep apnea (OSA) are at increased risk of developing sleep disturbances after surgery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, analgesic, and anxiolytic effects. Ketamine is a noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist. Esketamine is the S-enantiomer of racemic ketamine and twice as potent as racemic ketamine for analgesia. A recent trial showed that mini-dose esketamine-dexmedetomidine in combination with opioids improved analgesia and subjective sleep quality after scoliosis correction surgery. This trial is designed to test the hypothesis that mini-dose dexmedetomidine-esketamine supplemented analgesia may improve postoperative sleep quality in patients at high-risk of OSA.
- Detailed Description
Obstructive sleep apnea (OSA) is characterized by repetitive narrowing or obstruction of the upper airway during sleep, resulting in recurrent hypoxemia and hypercapnia and disordered sleep. During the postoperative period, the residual effects of anesthetics, sedatives, analgesics, and muscle relaxants suppress the activation of airway muscles; surgical stress, pain, and environmental interference further deteriorate sleep quality. All these factors aggravate the pathophysiological changes in OSA patients and may lead to worse perioperative outcomes, including increased respiratory and cardiac events, intensive care unit (ICU) admission and delirium, as well as prolonged length of hospital stay.
Opioids are commonly used for postoperative analgesia. Patients with OSA have significantly increased sensitivity to the side effects of opioids, such as central respiratory depression (reduced central respiratory drive) and peripheral respiratory depression (airway collapse). Opioids themselves can also cause sleep disturbances, as manifested by sleep fragmentation, decreased rapid-eye-movement sleep, and frequent nightmares. On the other hand, sleep deprivations can also lead to increased pain sensitivity and thus opioid consumption. Therefore, it is important to explore better postoperative analgesia to improve postoperative sleep quality of patients at high-risk of OSA.
Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, analgesic, and anxiolytic effects. It produces sedation by activating the endogenous sleep-promoting pathway and produces a state resembling nonrapid eye movement sleep. Ketamine is a noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist. When given in sub-anaesthetic doses, ketamine produces analgesic and anti-hyperalgesic effects and is recommended as a component of multimodal analgesia. Esketamine is the S-enantiomer of racemic ketamine and approximately twice as potent as racemic ketamine for analgesia.
A recent trial showed that mini-dose esketamine-dexmedetomidine in combination with opioids improved analgesia and subjective sleep quality after scoliosis correction surgery. This trial is designed to test the hypothesis that mini-dose dexmedetomidine-esketamine supplemented analgesia may improve sleep quality in patients at high-risk of OSA after thoracic or abdominal surgery.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexmedetomidine-esketamine combination Dexmedetomidine-esketamine combination Patient-controlled analgesia is established with dexmedetomidine (1 μg/ml), esketamine (1 mg/ml), and sufentanil (1 μg/ml) in a total volume of 100 ml. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h. Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours after surgery. Placebo Placebo Patient-controlled analgesia is established with sufentanil (1 μg/ml) in a total volume of 100 ml. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h. Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours after surgery.
- Primary Outcome Measures
Name Time Method Subjective sleep quality during the first night after surgery. During the first night after surgery. Subjective sleep quality is assessed with the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a self-reported measure of subjective sleep quality with 5 items, including sleep depth, sleep latency, awakening, return to sleep, and overall sleep quality; the score of each item ranges from 0 to 100, with a higher score indicating better sleep.
- Secondary Outcome Measures
Name Time Method Sleep structure parameters during the first night after surgery. During the first night after surgery Sleep structure is monitored with a polysomnograph from 9:00 pm on the night of surgery to 6:00 am the next morning. Sleep stages and respiratory events are scored according to the American Academy of Sleep Medicine (AASM) manual by qualified sleep physicians.
Cumulative subjective sleep quality score after surgery During the first three nights after surgery. Subjective sleep quality is assessed with the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a self-reported measure of subjective sleep quality with 5 items, including sleep depth, sleep latency, awakening, return to sleep, and overall sleep quality; the score of each item ranges from 0 to 100, with a higher score indicating better sleep.
Proportion of patients with poor sleep quality after surgery. During the first three nights after surgery. Subjective sleep quality is assessed with the Richards-Campbell Sleep Questionnaire (RCSQ). Poor sleep quality is defined as overall RCSQ\<50 on any night after surgery.
Area under curve of pain intensity score within 3 days after surgery. Up to 3 days after surgery. Pain intensity is assessed twice daily (8-10 am and 18-20 pm) with the numeric rating scale (NRS), an 11-point scale where 0=no pain and 10=the worst pain.
Subjective sleep quality at 30 days after surgery. At 30 days after surgery. Subjective sleep quality is assessed with the Pittsburgh Sleep Quality Index (PSQI; score ranges from 0 to 21, with higher score indicating worse sleep quality).
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China