Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality
- Conditions
- Hip Fractures
- Interventions
- Drug: Normal saline
- Registration Number
- NCT07002723
- Lead Sponsor
- Peking University Shenzhen Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- Age≥ 65 years old;
- Hip fracture surgery under neuraxial anesthesia;
- Signed informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Esketamine combined with dexmedetomidine group Esketamine combined with dexmedetomidine After successful neuraxial anesthesia, 0.125mg/kg esketamine and 0.3ug/kg dexmedetomidine were 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. Normal saline group 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.
- Primary Outcome Measures
Name Time Method sleep quality the first postoperative night Richards-Campbell sleep questionnaire (RCSQ) score is used to assess the sleep quality, the total score is 100 point, the lowest score is 0 point, and the highest score is 100 point, with higher scores representing better sleep quality.
- Secondary Outcome Measures
Name Time Method sleep quality the second postoperative night, third postoperative night Richards-Campbell sleep questionnaire (RCSQ) score is used to assess the sleep quality, the total score is 100 point, the lowest score is 0 point, and the highest score is 100 point, with higher scores representing better sleep quality.
Incidence of delirium from the first to the fifth postoperative day Incidence of delirium
pain score(FPS-R) from the first day to the fifth postoperative day Wong-Baker facial expression pain scale revision (FPS-R) at rest and during activity, the lowest score is 0 point, and the highest score is 10 points, with higher scores indicating more severe pain.
pain (NRS) from the first day to the fifth postoperative day Numeric Rating Scale (NRS) at rest and during activity, the total score is 10 points, the lowest score is 0 point, and the highest score is 10 points, with higher scores indicating more severe pain.
drugs from the first day to the fifth postoperative day Additional consumption of analgesic drugs
complications perioperatively Postoperative complications during hospitalization: pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, hypotension, bradycardia, dizziness, nausea, vomiting, nightmares and other psychiatric symptoms
Cognitive function one month after surgery Cognitive function ： Montreal Cognitive Assessment (t-MoCA) score of the telephone version, the total score is 22 points, with a minimum of 0 point and a maximum of 22 points, with higher scores, the cognitive function is better.
Mortality rate one month after surgery Mortality rate
outcomes one month after surgery complications
Trial Locations
- Locations (1)
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China