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NCT Number: NCT07002723

Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location status: Recruiting

Location contact

Tao Luo, MD,PhD

CONTACT

[email protected]

13510820779

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. sleep quality

    Time frame: 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 outcomes

  1. sleep quality

    Time frame: 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.

  2. Incidence of delirium

    Time frame: from the first to the fifth postoperative day

    Incidence of delirium

  3. pain score(FPS-R)

    Time frame: 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.

  4. pain (NRS)

    Time frame: 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.

  5. drugs

    Time frame: from the first day to the fifth postoperative day

    Additional consumption of analgesic drugs

  6. complications

    Time frame: perioperatively

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

  7. Cognitive function

    Time frame: 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.

  8. Mortality rate

    Time frame: one month after surgery

    Mortality rate

  9. outcomes

    Time frame: one month after surgery

    complications

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Luo, MD,PhD

CONTACT

[email protected]

13510820779

Sponsors and collaborators

Lead sponsor

Peking University Shenzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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