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Effect of nocturnal S-ketamine for prevention of postoperative delirium in elderly patients after major surgery: a randomized controlled trial

Effect of nocturnal S-ketamine for prevention of postoperative delirium in elderly patients after major surgery: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061996
Enrollment
Unknown
Registered
2022-07-16
Start date
2022-07-11
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

elderly patients undergoing major surgery

Interventions

Experimental group:Esketamine was given as a continuous infusion at a rate of 2 ug/kg/min from 20:00 on the night of the operation to 6:00 the next day.
Control group:Saline was given as a continuous infusion at the same rate for the same time.

Sponsors

The Second Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 65 years or older who underwent elective non-cardiac surgery under general anaesthesia; 2. Gender is not limited; 3. Patients who voluntarily join and sign informed consent after fully explaining the content of the clinical trial.

Exclusion criteria

Exclusion criteria: 1. Allergic to drugs used in the study; 2. Preoperative history of schizophrenia, epilepsy, Parkinson's disease, and delirium; 3. Patients taking antipsychotic drugs; 4. Individuals for whom a significant elevation of blood pressure would constitute a serious hazard (eg, phaeochromocytoma or aortic dissection); 5. Patients with increased intracranial pressure or intraocular pressure; 6. Inability to communicate in the preoperative period (coma, profound dementia, or language barrier); 7. Brain injury or neurosurgery; 8. Cardiac insufficiency and known preoperative left ventricular ejection fraction less than 40%; 9. Serious hepatic dysfunction (Child-Pugh class C); 10. Serious renal dysfunction (undergoing dialysis before surgery); 11. Low likelihood of survival for more than 24 h.

Design outcomes

Primary

MeasureTime frame
the incidence of delirium in the first 3 postoperative days;

Secondary

MeasureTime frame
type of surgery;anesthesia method;duration of surgery;duration of anesthesia;time to extubation;duration of AICU stay;length of stay in hospital after surgery;Intraoperative blood loss and urine volume;infusion time of S-ketamine;whether to adjust the use of S-ketamine;adverse events;the frequency of PCIA;sleep quality score;time to first onset of delirium;delirium type;

Countries

China

Contacts

Public ContactYun Wu

The Second Affiliated Hospital of Anhui Medical University

wuyunanyi@163.com+86 13865958254

Outcome results

None listed

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