Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality

Официальное название

Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality in Elderly Patients Undergoing Hip Surgery:A Superiority Randomized Controlled Trail

Обзор

1. Eligible patients are randomly divided into experimental and control groups； 2. The experimental group is given esketamine combined with dexmedetomidine，while the control group is given normal saline； 3. The patients' sleep, pain, and cognition are followed up after surgery.

Подробное описание

One day before surgery, the investigators collect baseline data from patients at the bedside. Preoperative sleep quality is assessed using Pittsburgh sleep quality index(PSQI); Three-Minute Confusion Assessment Method(3D-CAM)is used to assess the incidence of delirium; cognitive function is assessed using Montreal Cognitive Assessment(MoCA); The Hospital Anxiety and Depression Scale (HADS) is used to assess patients' mood; Wong-Baker faces pain scale revision(FPS-R) and Numeric Rating Scale(NRS) are used to assess the patient's pain score at rest and during activity, and laboratory tests (Hb, Alb, K, NA, Cr, Alb, e-GFR) are recorded.

On the day of surgery, after successful neuraxial anesthesia, in the experimental group ，0.125mg/kg esketamine and 0.3ug/kg dexmedetomidine are diluted into 30ml of normal saline and continuously pumped for 20 minutes, followed by a micropump: 15ug/kg/h esketamine 0.02ug/kg/h dexmedetomidine to 96ml saline, continuous amount: 2ml/h, continuous pumping for 48h. Morphine 1 mg is given epidural at the beginning of surgery；while in the control group, same amount of normal saline is given. The patients are followed up for sleep quality, pain and delirium incidence after surgery. Long-term telephone follow-up of patients are focused on their cognitive function and recovery quality.

Вмешательства

• Препарат Esketamine combined with dexmedetomidine
  After successful neuraxial anesthesia, 0.125mg/kg esketamine and 0.3ug/kg dexmedetomidine are diluted into 30ml of normal saline and continuously pumped for 20 minutes, then connected to a micropump: 15ug/kg/h esketamine 0.02ug/kg/h dexmedetomidine to 96ml saline, continuous amount: 2ml/h, continuous pumping for 48h.
• Препарат Normal saline
  After successful neuraxial anesthesia, 30ml of normal saline was continuously pumped for 20 minutes, followed by a micropump: 96ml of saline, continuous amount: 2ml/h for 48h.

Первичные конечные точки

• sleep quality [Срок оценки: the first postoperative night]

Вторичные конечные точки (9)

• sleep quality [Срок оценки: the second postoperative night, third postoperative night]
• Incidence of delirium [Срок оценки: from the first to the fifth postoperative day]
• pain score(FPS-R) [Срок оценки: from the first day to the fifth postoperative day]
• pain (NRS) [Срок оценки: from the first day to the fifth postoperative day]
• drugs [Срок оценки: from the first day to the fifth postoperative day]
• complications [Срок оценки: perioperatively]
• Cognitive function [Срок оценки: one month after surgery]
• Mortality rate [Срок оценки: one month after surgery]
• outcomes [Срок оценки: one month after surgery]

Критерии участия

Критерии включения

• Age≥ 65 years old;
• Hip fracture surgery under neuraxial anesthesia;
• Signed informed consent.

Критерии исключения

• ASA classification≥ Class V;
• Presence of neuraxial anesthesia contraindications: coagulation dysfunction, thrombocytopenia, neuraxial mass, puncture site infection, etc.;
• Patients with contraindications to esketamine (such as allergies, intracranial aneurysms, hyperthyroidism and glaucoma);
• Patients with contraindications to dexmedetomidine (allergies);
• Patients with severe cardiovascular diseases such as sick sinus syndrome, severe sinus bradycardia (heart rate < 50 beats/min), atrioventricular block grade II or above without pacemaker, unstable angina, severe valvular heart disease, severe arrhythmia, severe macrovascular disease with New York Heart Association class III patients, etc.;
• Obstructive sleep apnea syndrome (STOP-BANG score > 3 points);
• Patients with severe hepatic and renal insufficiency (such as Child-Pugh score III, creatinine clearance < 35 mL/min, preoperative dialysis);
• Those who have delirium, dementia, moderate to severe cognitive dysfunction and psychiatric disorders before the start of the trial and are unable to communicate and cooperate with the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Shenzhen Hospital — Шэньчжэнь

Публикации

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• Chen H, Fang Z, Wu YY, Zhao CH, Wang YJ, Zhu XH, Cheng XQ. Association between perioperative self-reported sleep disturbances and delirium risk in elderly patients following total joint arthroplasty: a cohort study. J Sleep Res. 2024 Oct;33(5):e14168. doi: 10.1111/jsr.14168. Epub 2024 Feb 21. PMID 38380761
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Идентификаторы

NCT: NCT07002723 · 2025-045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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