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A randomized controlled trial on effect of esketamine on postoperative neurocognitive function in elderly patients under general anesthesia

A randomized controlled trial on effect of esketamine on postoperative neurocognitive function in elderly patients under general anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050307
Enrollment
Unknown
Registered
2021-08-26
Start date
2021-08-22
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

perioperative neurocognitive impairment

Interventions

Experimental group:After induction of conventional anesthesia protocol, 0.2mg/kg/h esmketamine was injected intravenously

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Willing to participate and able to provide informed consent; 2.The duration of operation was more than 2 hours in patients undergoing non-cardiac, non-neurosurgical, and non-gastrointestinal open surgery under general anesthesia in our hospital; 3.Aged >= 60, ASA I~III, BMI 18-30 kg / m^2; 4.There was no clinical trial of other drugs in 3 months before screening.

Exclusion criteria

Exclusion criteria: 1.Patients who are allergic to active ingredients or all excipients of esketamine; 2.Unable to complete neuropsychological test (including severe visual or hearing impairment) or MMSE 180/100mmhg); 5.Combined with other important organ dysfunction: including severe liver and kidney dysfunction; brain organic lesions, such as tumor vascular disease or arteriovenous malformation, stroke, dementia, and other histories; Cardiac insufficiency (NYHA >= grade III); 6.Emergency, cardiac or intracranial surgery patients; 7.The patients were hospitalized within 3 months; 8.Patients with a history of alcohol, drug dependence, or abuse; 9.Patients with a history of mental illness such as bipolar disorder, severe depression, schizophrenia, or dementia; 10.Patients with difficult follow-up or poor compliance.

Design outcomes

Primary

MeasureTime frame
delirium;cognitive function;subjective sleep quality;

Secondary

MeasureTime frame
postoperative cognitive dysfunction;postoperative extubation time;monitor the treatment room stay time after postoperative anesthesia;inflammatory cytokines level ;faecal microbiota composition;the amount of anesthetic drugs used during the operation;intraoperative vasoactive drug dosage;postoperative pain during hospitalization;depression;anxiety;

Countries

China

Contacts

Public ContactLi Yalan

The First Affiliated Hospital of Ji'nan University

tyalan@jnu.edu.cn+86 13500013993

Outcome results

None listed

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