Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery

NCT06859892 | Recruiting Phase 4

• 1 other identifier: 2024-729
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adults; Major Noncardiac Surgery; Dexmedetomidine; Esketamine; Postoperative Sleep Disturbances

Keywords

adults; major noncardiac surgery; dexmedetomidine; esketamine; postoperative sleep disturbances

Outcome Measures

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.

  Up to 3 days after surgery

Secondary Outcomes (5)

• Quality of recovery at 24 hours after surgery

  At 24 hours after surgery

• Subjective sleep quality in the first 3 nights after surgery.

  Up to 3 days after surgery.

• Pain intensity both at rest and with movement during the first 3 postoperative days

  Up to 3 days after surgery

• Anxiety and depression on the third day after surgery

  On the third day after surgery

• Subjective sleep quality on the 30th day after surgery

  On the 30th day after surgery

Other Outcomes (8)

• Time to extubation after surgery

  On the day of surgery

• Incidence of emergence agitation after surgery

  Up to 2 hours after extubation

• Cumulative opioid consumption within 48 hours after surgery

  Within 48 hours after surgery

Study Arms (2)

Dexmedetomidine-esketamine group

EXPERIMENTAL

Dexmedetomidine-esketamine combination is infused during general anesthesia and used as a supplement for patient-controlled intravenous analgesia after surgery.

Drug: Dexmedetomidine-esketamine combination

Placebo group

PLACEBO COMPARATOR

Placebo (normal saline) is infused during general anesthesia and used as a supplement for patient-controlled intravenous analgesia after surgery.

Drug: Placebo

Interventions

Dexmedetomidine-esketamine combination DRUG

Dexmedetomidine 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.

Dexmedetomidine-esketamine group

Placebo DRUG

Placebo (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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Inability to communicate due to coma, severe dementia, or speech disorders, endured hypoxic encephalopathy or traumatic brain injury, or after neurosurgery.
• Comorbid with hyperthyroidism and pheochromocytoma.
• Preoperative left ventricular ejection fraction \<30%, sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), atrioventricular block of degree II or higher without pacemaker implantation, or systolic blood pressure below 90 mmHg despite use of vasopressors.
• Diagnosed as sleep apnea, or judged to be at high risk of moderate-to-severe sleep apnea as assessed by STOP-Bang.
• Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (on dialysis), or ASA classification ≥IV.
• Hypersensitive to dexmedetomidine and/or esketamine.
• Other conditions that are deemed unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

RECRUITING

Related Publications (17)

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Study Officials

• Dong-Xin Wang

  Dong-Xin Wang, MD, PhD, Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

Mo Li, MD, PhD

CONTACT

+86 19801260665; 2361011139@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Department of Anesthesiology

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)