Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery. The purpose of this trial is to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years.
Scheduled for major noncardiac surgery (≥60 minutes) under general anesthesia with an expected end of surgery no later than 18:00 pm.
Required patient-controlled intravenous analgesia after surgery.
Disqualifiers
Emergency surgery, transurethral surgery, organ transplantation.
Pregnant or lactating women.
Patients who need hypnotics for sleep disturbance or antidepressants for depression prior to surgery.
History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine-esketamine combination
DrugDexmedetomidine 0.4 μg/kg and esketamine 0.2 mg/kg is infused over 10 minutes before anesthesia induction. Dexmedetomidine 0.20 μg/kg/h and esketamine 0.10 mg/kg/h is then infused until 60 minutes before the expected end of surgery. Patient-controlled intravenous analgesia is established with 100 μg dexmedetomidine, 50 mg esketamine, and 100 μg sufentanil, diluted to 100 mL with normal saline, and programmed to deliver 2-mL boluses with a lock-out interval of 8 minutes and background infusion rate at 1 mL/h for up to 72 hours after surgery.
Placebo
DrugPlacebo (normal saline) is administered in the same rate and volume as that in the dexmedetomidine-esketamine group. Patient-controlled intravenous analgesia is established with 100 μg sufentanil, diluted to 100 mL with normal saline, and programmed to deliver 2-mL boluses with a lock-out interval of 8 minutes and background infusion rate at 1 mL/h for up to 72 hours after surgery.
Treatment groups
476 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine-esketamine groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of sleep disturbances within 3 days after surgery
Sleep disturbances are defined as Richards-Campbell Sleep Questionnaire (RCSQ) score below 50, based on assessments conducted daily between 8:00 am and 10:00 am during postoperative days 1 to 3.
Time frame
Up to 3 days after surgerySecondary outcomes
1
Quality of recovery at 24 hours after surgery
Quality of recovery is assessed using the Quality of Recovery-15 (QoR-15) scale at 24 hours after surgery. The total QoR-15 scores are evaluated based on physical comfort (five items), emotional state (four items), psychological support (two items), physical independence (two items), and pain (two items) for QoR-15 questionnaire. Each item is scored from 0 to 10, and the possible total score ranges from 0 to 150, with higher scores representing better recovery quality after operation.
Time frame
At 24 hours after surgery2
Subjective sleep quality in the first 3 nights after surgery.
Subjective sleep quality is assessed daily (8:00 am to 10:00 am) using the Richards-Campbell Sleep Questionnaire (RCSQ) during the first 3 postoperative days. Richards-Campbell Sleep Questionnaire (RCSQ) comprises five items: sleep depth, sleep latency, awakenings, returning to sleep, and sleep quality. Each item is assessed with a 100-mm visual analog scale. The scores range from 0, indicating the worst possible sleep, to 100, indicating the best possible sleep. The total RCSQ sleep score is derived by summing up the individual scores on the five sleep items and dividing it by 5.
Time frame
Up to 3 days after surgery.3
Pain intensity both at rest and with movement during the first 3 postoperative days
Pain intensity is assessed with the numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) twice daily (8:00 am to 10:00 am, and 18:00 pm to 20:00 pm) both at rest and with movement during the first 3 postoperative days.
Time frame
Up to 3 days after surgery4
Anxiety and depression on the third day after surgery
Postoperative anxiety and depression are assessed using the Hospital Anxiety and Depression Scale (HADS), with scores categorized as follows: 0-7 (negative), 8-10 (mild), 11-14 (moderate), and 15-21 (severe).
Time frame
On the third day after surgeryOther outcomes
1
Time to extubation after surgery
Time interval from end of surgery to extubation.
Time frame
On the day of surgery2
Incidence of emergence agitation after surgery
Emergence agitation was defined as a Richmond Agitation-Sedation Scale (RASS) score ≥ +2 at any time point from tracheal extubation to discharge from the post-anesthesia care unit (PACU)
Time frame
Up to 2 hours after extubation3
Cumulative opioid consumption within 48 hours after surgery
Cumulative opioid consumption from end of surgery to 48 hours after surgery.
Time frame
Within 48 hours after surgery4
Proportion of patients requiring rescue analgesia within 48 hours after surgery
Rescue analgesia indicates any analgesics in addition to patient-controlled intravenous analgesia.
Time frame
Within 48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov