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The impact of low-dose esketamine combined with dexmedetomidine on the recovery quality of elderly patients undergoing lumbar spine surgery: A randomized, controlled study

The impact of low-dose esketamine combined with dexmedetomidine on the recovery quality of elderly patients undergoing lumbar spine surgery: A randomized, controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116297
Enrollment
Unknown
Registered
2026-01-08
Start date
2026-01-14
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients undergoing posterior approach lumbar surgery

Interventions

Dexmedetomidine (Group D):During induction, dexmedetomidine was administered intravenously at a dose of 0.5 µg/kg, and the maintenance dose was 0.2 µg/kg/h.
The esketamine group (Group E):Intravenously inject esketamine at a dose of 0.25mg/kg initially, and maintain the dosage at 0.125mg/kg/h.
The combined group of esketamine and dexmedetomidine (ED group):Induction with esketamine 0.25mg/kg + dexmedetomidine 0.5µg/kg, with maintenance doses of 0.125mg/kg/h and 0.2µg/kg/h, respectively.

Sponsors

Hefei First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients who undergo elective posterior approach lumbar surgery (such as spinal canal decompression surgery, lumbar fusion surgery, etc.); 2. Age >= 60 years old, gender not limited, ASA classification I-III level; 3. No history of severe heart, lung, liver or kidney dysfunction or mental illness; 4. Clearly describe the content of the clinical trial, and patients voluntarily join and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The patient was already in a state of fatigue before the operation (with an ICFS-10 score greater than 24 points); 2. Allergic to esketamine or dexmedetomidine or having contraindications for their use; 3. Patients who have been using sedative/pain-relieving drugs for a long time; 4. Preoperative cognitive dysfunction (MMSE score < 24); 5. Patients who have taken pain-relieving and sedative medications recently; 6. Those with psychological or mental abnormalities or mental illnesses; 7. Severe heart (NYHA IV grade), liver (Child-Pugh C grade), and kidney (on dialysis) dysfunction; 8. Patients who participated in other treatments in the past 6 months (at the time of obtaining consent); 9. Patients who are judged to lack the ability to consent; 10. Other patients who were judged by the clinical responsible doctor or the clinical supervisor doctor to be unsuitable.

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative fatigue;

Secondary

MeasureTime frame
The incidence of postoperative delirium;Anesthesia duration, operation time, recovery time, extubation time, intraoperative blood loss, intraoperative fluid infusion volume, urine output;QoR-15score;VAS pain grade;The time of the first postoperative ambulation and the length of hospital stay;Postoperative adverse reactions (such as nausea, vomiting, dizziness, double vision, nightmares, etc.);The RASS sedation score 30 minutes after the operation;Mean Arterial Pressure (MAP), Heart Rate, SpO2;

Countries

China

Contacts

Public ContactYang Heng

Hefei First People's Hospital

yangh999@yeah.net+86 13966695354

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026