Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years but ≤80 years;
Preoperative diagnosis of OSA, or judged to be at moderate-to-high risk of OSA according to the STOP-Bang Questionnaire;
Scheduled to undergo thoracoscopic or laparoscopic surgery under general anesthesia, with an expected surgical duration of ≥1 hours, and required patient-controlled intravenous analgesia (PCIA) after surgery.
Disqualifiers
Diagnosed as central sleep apnea syndrome;
Previous history of schizophrenia, epilepsy, Parkinson disease, or myasthenia gravis.
History of schizophrenia, or having antipsychotic drugs (including antidepressants or anxiolytics);
Inability to communicate in the preoperative period because of coma, profound dementia, or deafness;
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine-esketamine combination
DrugPatient-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
DrugPatient-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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine-esketamine combinationExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During the first night after surgery.Secondary outcomes
1
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.
Time frame
During the first night after surgery2
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.
Time frame
During the first three nights after surgery.3
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.
Time frame
During the first three nights after surgery.4
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.
Time frame
Up to 3 days after surgery.Other outcomes
1
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.
Time frame
Up to 3 days after surgery.2
Length of stay in hospital after surgery.
Length of stay in hospital after surgery.
Time frame
Up to 30 days after surgery.3
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.
Time frame
At 30 days after surgery.4
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.
Time frame
Up to 30 days after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov