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The Effect of Subanesthetic Doses of Esketamine on Perioperative Neurocognitive Disorders in Patients with Metabolic Syndrome Undergoing Major Abdominal Surgery

The Effect of Subanesthetic Doses of Esketamine on Perioperative Neurocognitive Disorders in Patients with Metabolic Syndrome Undergoing Major Abdominal Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104082
Enrollment
Unknown
Registered
2025-06-10
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Neurocognitive Dysfunction

Interventions

Esketamine group:During induction, administer a bolus of esketamine at 0.25 mg/kg, followed by a continuous infusion of esketamine at 0.125 mg/kg/h until 1 hour before the end of the surgery.
Control group:Administer an equal dose of saline solution at the same time point.

Sponsors

Yantai Yuhuangding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Persons aged 35-80 years who meet the diagnostic criteria for metabolic syndrome, ASA grade I-III., patients undergoing major abdominal surgery, operation time > 2h, and informed consent of patients. International Diabetes Federation (IDF) criteria need to be met: The IDF criteria emphasize the centrality of abdominal obesity and need to meet at least three of the following five criteria: (1) Abdominal obesity (i.e., central obesity): waist circumference >=90 cm for men and 80 cm >= for women. A BMI of >30 can be used instead. (2) Hyperglycemia: fasting blood glucose = 6.1 mmol/L or blood glucose >= 7.8mmol/L 2 h after glucose load and/or those who have been diagnosed with diabetes mellitus and treated. (3) Hypertension: blood pressure >= 130/85 mmHg (1 mmHg=0.133 kPa) and/or those who have been confirmed to be hypertension and treated. (4) Fasting triglycerides (TG) >= 1.70mmol/L. (5) Fasting HDL C<1.04mmol/L.

Exclusion criteria

Exclusion criteria: 1.Patients with central nervous system diseases, mental disorders or psychological disorders before surgery had a Mini-Mental State Examination (MMSE) score of <24 points and a Delirium Observation Scale (DOS) score of =3 points. 2.Patients with known intolerance to esketamine, lack of cooperation, or impaired communication abilities (e.g., language barriers, autism, aphasia, coma, terminal illness, or drug/alcohol abuse). 3.Patients with severe liver or kidney dysfunction; 4.Patients with secondary factors affecting metabolism, such as hyperthyroidism. 5.Patients with severe hypertension and cardiovascular or cerebrovascular diseases. 6.Patients with hearing or visual impairments that hinder normal communication. 7.Patients with unsatisfactory surgical outcomes who require immediate secondary surgery.

Design outcomes

Secondary

MeasureTime frame
MAP;HR;BIS;Major Adverse Cardiovascular Events;Surgical time;Duration of anesthesia;Volume of blood loss;Propofol and remifentanil consumption;Total volume of crystalloids and colloids;Vasoactive drug administration;Sufentanil rescue analgesia;The QoR-15 score;

Primary

MeasureTime frame
Incidence rate of DNR;Mini-Mental State Examination Score;Postoperative delirium incidence;

Countries

China

Contacts

Public ContactMa Jiahai

Yantai Yuhuangding Hospital

mjh-214@163.com+86 136 5645 6186

Outcome results

None listed

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