Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality

NCT07002723 | Recruiting DMC

• 1 other identifier: 2025-045
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• sleep quality

  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.

  the first postoperative night

Secondary Outcomes (9)

• sleep quality

  the second postoperative night, third postoperative night

• Incidence of delirium

  from the first to the fifth postoperative day

• pain score(FPS-R)

  from the first day to the fifth postoperative day

• pain (NRS)

  from the first day to the fifth postoperative day

• drugs

  from the first day to the fifth postoperative day

Study Arms (2)

Esketamine combined with dexmedetomidine group

EXPERIMENTAL

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.

Drug: Esketamine combined with dexmedetomidine

Normal saline group

PLACEBO COMPARATOR

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.

Drug: Normal saline

Interventions

Esketamine combined with dexmedetomidine DRUG

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.

Esketamine combined with dexmedetomidine group

Normal saline DRUG

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.

Normal saline group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Shenzhen Hospital: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

Related Publications (25)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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):456-466. doi: 10.1097/AAP.0000000000000806.

  PMID: 29870457 BACKGROUND

• Song B, Zhu J. A Novel Application of Ketamine for Improving Perioperative Sleep Disturbances. Nat Sci Sleep. 2021 Dec 25;13:2251-2266. doi: 10.2147/NSS.S341161. eCollection 2021.

  PMID: 34992482 BACKGROUND

• Horacek J, Janda R, Gornerova N, Jajcay L, Andrashko V. Several reasons why ketamine as a neuroplastic agent may have failed to prevent postoperative delirium: Implications for future protocols. Neurosci Lett. 2023 Feb 28;798:137095. doi: 10.1016/j.neulet.2023.137095. Epub 2023 Jan 21.

  PMID: 36693556 BACKGROUND

• Soffin EM, Gibbons MM, Wick EC, Kates SL, Cannesson M, Scott MJ, Grant MC, Ko SS, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Hip Fracture Surgery. Anesth Analg. 2019 Jun;128(6):1107-1117. doi: 10.1213/ANE.0000000000003925.

  PMID: 31094775 BACKGROUND

• Zhu Y, Feng W, Kong Q, Sheng F, Li Z, Xu W, Li Q, Han Y, Wu X, Jia C, Guo J, Zhao Y. Evaluating the effects of S-ketamine on postoperative delirium in elderly patients following total hip or knee arthroplasty under intraspinal anesthesia: a single-center randomized, double-blind, placebo-controlled, pragmatic study protocol. Front Aging Neurosci. 2023 Nov 30;15:1298661. doi: 10.3389/fnagi.2023.1298661. eCollection 2023.

  PMID: 38099265 BACKGROUND

• Krenk L, Jennum P, Kehlet H. Sleep disturbances after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Nov;109(5):769-75. doi: 10.1093/bja/aes252. Epub 2012 Jul 24.

  PMID: 22831887 RESULT

• Shakya H, Wang D, Zhou K, Luo ZY, Dahal S, Zhou ZK. Prospective randomized controlled study on improving sleep quality and impact of zolpidem after total hip arthroplasty. J Orthop Surg Res. 2019 Sep 3;14(1):289. doi: 10.1186/s13018-019-1327-2.

  PMID: 31481074 RESULT

• Liu X, Hu X, Li R, Zhang Y. Combination of post-fascia iliaca compartment block and dexmedetomidine in pain and inflammation control after total hip arthroplasty for elder patients: a randomized control study. J Orthop Surg Res. 2020 Feb 10;15(1):42. doi: 10.1186/s13018-020-1562-6.

  PMID: 32041613 RESULT

• Shafiei SH, Siavashi B, Ghasemi M, Golbakhsh MR, Baghdadi S. Single High-Dose Systemic Methylprednisolone Administered Preoperatively Improves Pain Control and Sleep Quality After Total Hip Arthroplasty: A Double-Blind, Randomized Controlled Trial. Arthroplast Today. 2022 May 30;16:78-82. doi: 10.1016/j.artd.2022.03.006. eCollection 2022 Aug.

  PMID: 35662994 RESULT

• Bornemann-Cimenti H, Wejbora M, Michaeli K, Edler A, Sandner-Kiesling A. The effects of minimal-dose versus low-dose S-ketamine on opioid consumption, hyperalgesia, and postoperative delirium: a triple-blinded, randomized, active- and placebo-controlled clinical trial. Minerva Anestesiol. 2016 Oct;82(10):1069-1076. Epub 2016 Jun 21.

  PMID: 27327855 RESULT

• Chen Z, Tang R, Zhang R, Jiang Y, Liu Y. Effects of dexmedetomidine administered for postoperative analgesia on sleep quality in patients undergoing abdominal hysterectomy. J Clin Anesth. 2017 Feb;36:118-122. doi: 10.1016/j.jclinane.2016.10.022. Epub 2016 Dec 1.

  PMID: 28183547 RESULT

• Liu H, Wei H, Qian S, Liu J, Xu W, Luo X, Fang J, Liu Q, Cai F. Effects of dexmedetomidine on postoperative sleep quality: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2023 Mar 21;23(1):88. doi: 10.1186/s12871-023-02048-6.

  PMID: 36944937 RESULT

• Zhu S, Liu Y, Wang X, Wang L, Li J, Xue X, Li Z, Liu J, Liu X, Zhao S. Different Sedation Strategies in Older Patients Receiving Spinal Anesthesia for Hip Surgery on Postoperative Delirium: A Randomized Clinical Trial. Drug Des Devel Ther. 2023 Dec 29;17:3845-3854. doi: 10.2147/DDDT.S439543. eCollection 2023.

  PMID: 38169975 RESULT

• Ye Q, Hu Y, Xing Q, Wu Y, Zhang Y. The Effects of Opioid-Free Anesthesia with Dexmedetomidine and Esketamine on Postoperative Anesthetic-Related Complications for Hip Surgery in the Elderly. Int J Gen Med. 2024 Dec 17;17:6291-6302. doi: 10.2147/IJGM.S492771. eCollection 2024.

  PMID: 39712198 RESULT

• Zhang Y, Cui F, Ma JH, Wang DX. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Br J Anaesth. 2023 Aug;131(2):385-396. doi: 10.1016/j.bja.2023.05.001. Epub 2023 Jun 9.

  PMID: 37302963 RESULT

• Yang JR, Li YY, Ran TJ, Lin XY, Xu JY, Zhou SL, Huang PJ. Esketamine Combined with Dexmedetomidine to reduce Visceral Pain During elective Cesarean Section Under Combined Spinal-Epidural Anesthesia: A double-Blind Randomized Controlled Study. Drug Des Devel Ther. 2024 Jun 18;18:2381-2392. doi: 10.2147/DDDT.S460924. eCollection 2024.

  PMID: 38911034 RESULT

• Griffiths R, Babu S, Dixon P, Freeman N, Hurford D, Kelleher E, Moppett I, Ray D, Sahota O, Shields M, White S. Guideline for the management of hip fractures 2020: Guideline by the Association of Anaesthetists. Anaesthesia. 2021 Feb;76(2):225-237. doi: 10.1111/anae.15291. Epub 2020 Dec 2.

  PMID: 33289066 RESULT

• Song Y, Liu Y, Yuan Y, Jia X, Zhang W, Wang G, Jia Y, Wang X, Liu L, Li W, Li X, Cai N, Liu C, Li Y, Han Y, Zhou Y, Mi X, Shi C, Wang JQ, Vuylsteke A, Guo X, Li Z. Effects of general versus subarachnoid anaesthesia on circadian melatonin rhythm and postoperative delirium in elderly patients undergoing hip fracture surgery: A prospective cohort clinical trial. EBioMedicine. 2021 Aug;70:103490. doi: 10.1016/j.ebiom.2021.103490. Epub 2021 Jul 17.

  PMID: 34280784 RESULT

MeSH Terms

Conditions

Hip Fractures

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Tao Luo, MD,PhD

  Peking University Shenzhen Hospitai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Luo, MD,PhD

CONTACT

13510820779; luotao_wh@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: June 4, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)