Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA
NCT Number: NCT06566482
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Obstructive Sleep Apnea|Surgery|Dexmedetomidine|Esketamine|Postoperative Sleep Quality
Interventions: DRUG: Dexmedetomidine-esketamine combination|DRUG: Placebo
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2025-12
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

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.

Primary Outcome Measures: Subjective sleep quality 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., During the first night after surgery.
Secondary Outcome Measures: Sleep structure parameters 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., During the first night after surgery|Cumulative subjective sleep quality score 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., During the first three nights after surgery.|Proportion of patients with poor sleep quality 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., During the first three nights after surgery.|Area under curve of pain intensity score within 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., Up to 3 days after surgery.|Subjective sleep quality 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)., At 30 days after surgery.
Other Outcome Measures: Sedation level within 3 days after surgery., Sedation level is assessed at 2 hours and twice daily (8-10 am and 18-20 pm) after surgery with the Richmond Agitation Sedation Scale (RASS), with scores ranging from -5(unarousable) to +4 (combative) and 0 indicates alert and calm., Up to 3 days after surgery.|Length of stay in hospital after surgery., Length of stay in hospital after surgery., Up to 30 days after surgery.|Incidence of delayed neurocognitive recovery., Cognitive function is assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) before surgery and at 30 days after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined the occurrence of delayed neurocognitive recovery., At 30 days after surgery.|Incidence of major complications after surgery., Major complications are defined as new-onset medical events that are deemed harmful and require therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification., Up to 30 days after surgery.|All-cause 30-day mortality., All-cause 30-day mortality., Up to 30 days after surgery.