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Hip FracturesNCT07002723

Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality

A study testing Esketamine combined with dexmedetomidine and Normal saline in people with Hip Fractures, run by Peking University Shenzhen Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Hip Fractures
What is being tested?
Esketamine combined with dexmedetomidine and Normal saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteChina
Study dates
20 Jun 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tao Luo, MD,PhD contact

13510820779

luotao_wh@yahoo.com

China1 site, 1 recruiting
  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

    Tao Luo, MD,PhD, 13510820779, luotao_wh@yahoo.com

    Recruiting

Other trials in China

About this study

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

  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.
Read the 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.

Conditions
Hip Fractures
Being tested
Esketamine combined with dexmedetomidine, Normal saline
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Esketamine combined with dexmedetomidineDrug

    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.

  • Normal salineDrug

    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.

Study groups in NCT07002723
Study groupRoleWhat they receive
Esketamine combined with dexmedetomidine groupExperimentalAfter 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.
Receives: Drug: Esketamine combined with dexmedetomidine
Normal saline groupPlacebo comparatorAfter 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.
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: the first postoperative night

Secondary outcomes (9)
  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.

    Measured: the second postoperative night, third postoperative night

  2. Incidence of delirium

    Incidence of delirium

    Measured: from the first to the fifth postoperative day

  3. pain score(FPS-R)

    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.

    Measured: from the first day to the fifth postoperative day

  4. pain (NRS)

    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.

    Measured: from the first day to the fifth postoperative day

  5. drugs

    Additional consumption of analgesic drugs

    Measured: from the first day to the fifth postoperative day

  6. complications

    Postoperative complications during hospitalization: pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, hypotension, bradycardia, dizziness, nausea, vomiting, nightmares and other psychiatric symptoms

    Measured: perioperatively

  7. Cognitive function

    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.

    Measured: one month after surgery

  8. Mortality rate

    Mortality rate

    Measured: one month after surgery

  9. outcomes

    complications

    Measured: one month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study start20 Jun 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002723
Sponsor's protocol ID
2025-045
Status last verified
Apr 2025
First submitted
11 May 2025
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

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

    PubMed 29870457
  • 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.

    PubMed 34992482
  • 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.

    PubMed 36693556
  • 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.

    PubMed 31094775
  • 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.

    PubMed 38099265
  • 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.

    PubMed 22831887
  • 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.

    PubMed 31481074
  • 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.

    PubMed 32041613

Questions about this trial

What is this clinical trial studying?

A study testing Esketamine combined with dexmedetomidine and Normal saline in people with Hip Fractures, run by Peking University Shenzhen Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tao Luo, MD,PhD (13510820779, luotao_wh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sleep quality (time frame: the first postoperative night). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07002723, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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