Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality

Official title

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

Overview

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.

Interventions

• Drug 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.
• Drug 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

• sleep quality [Time frame: the first postoperative night]

Secondary outcome measures (9)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Peking University Shenzhen Hospital — Shenzhen

Publications

• Butris N, Tang E, Pivetta B, He D, Saripella A, Yan E, Englesakis M, Boulos MI, Nagappa M, Chung F. The prevalence and risk factors of sleep disturbances in surgical patients: A systematic review and meta-analysis. Sleep Med Rev. 2023 Jun;69:101786. doi: 10.1016/j.smrv.2023.101786. Epub 2023 Apr 19. PMID 37121133
• Qiu D, Wang XM, Yang JJ, Chen S, Yue CB, Hashimoto K, Yang JJ. Effect of Intraoperative Esketamine Infusion on Postoperative Sleep Disturbance After Gynecological Laparoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244514. doi: 10.1001/jamanetworkopen.2022.44514. PMID 36454569
• Su X, Wang DX. Improve postoperative sleep: what can we do? Curr Opin Anaesthesiol. 2018 Feb;31(1):83-88. doi: 10.1097/ACO.0000000000000538. PMID 29120927
• Myoji Y, Fujita K, Mawatari M, Tabuchi Y. Changes in sleep-wake rhythms, subjective sleep quality and pain among patients undergoing total hip arthroplasty. Int J Nurs Pract. 2015 Dec;21(6):764-70. doi: 10.1111/ijn.12345. Epub 2014 Apr 30. PMID 24779591
• Driesman AS, Montgomery WC, Kleeman-Forsthuber LT, Johnson RM, Dennis DA, Jennings JM. Perioperative Sleep Quality Disturbances in Total Joint Arthroplasty is Multifactorial. J Arthroplasty. 2024 Jun;39(6):1474-1479. doi: 10.1016/j.arth.2023.12.009. Epub 2023 Dec 8. PMID 38072098
• 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
• Pettit RJ, Gregory B, Stahl S, Buller LT, Deans C. Total Joint Arthroplasty and Sleep: The State of the Evidence. Arthroplast Today. 2024 Apr 24;27:101383. doi: 10.1016/j.artd.2024.101383. eCollection 2024 Jun. PMID 39071825
• Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-46 PMID 29870457

Identifiers

NCT: NCT07002723 · 2025-045

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗