Effects of Esketamine on the Incidence of Postoperative Delirium and Postoperative Sleep Disturbance in Elderly Patients After Major Non-cardiac Surgery (EPISODE)

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Postoperative Delirium (POD); Postoperative Sleep Disturbance

Treatments: Drug: 0.9 % saline; Drug: Esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06900205

2025-026

Details and patient eligibility

About

Postoperative delirium (POD) is a common surgical complication.It is associated with a range of negative outcomes such as delayed postoperative recovery,prolonged hospitalization,additional medical expenditures and higher mortality.

Meanwhile,sleep disorders are not only an important predisposing factor for delirium,but also one of the main symptoms of delirium.Systemic inflammatory responses caused by sleep disorders may be an important mechanism for POD.

Many studies have shown that esketamie may inhibit inflammatory factors and enhance neuroplasticity.

In summary,we felt the need to further explore the therapeutic potential of esketamine in the area of POD as well as postoperative sleep disorders.

Enrollment: 644 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≧ 65 years;
2. ASA Ⅰ-Ⅲ;
3. Elective major non-cardiac surgery;
4. Voluntary signed informed consent.

Exclusion criteria

1. People with mental illness;
2. Suffering from serious central nervous system disorders such as arkinson's disease, Alzheimer's disease, etc;
3. Elevated intracranial pressure;
4. Emergency or trauma surgery;
5. Prior history of postoperative delirium or postoperative cognitive decline;
6. The patient has impaired hearing or impaired vision;
7. Suffering from severe systemic underlying diseases (e.g. cardiac insufficiency, malignant arrhythmia, malignant hypertension, hepatic failure, renal failure, etc.);
8. The patient is in chronic pain;
9. The patient is severely malnourished;
10. Patients with stage 3 or 4 malignant tumors, pancreatic cancer, allbladder cancer, cholangiocarcinoma and other tumors with high malignancy and poor prognosis.
11. history of allergy to or contraindication to esketamine;
12. inability or unwillingness to complete questionnaires or clinical testing;
13. Unable or unwilling to use a postoperative intravenous analgesic pump.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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644 participants in 2 patient groups, including a placebo group

esketamine group

Experimental group

Description:

The esketamine group patients will be received esketamine perioperatively.

Treatment:

Drug: Esketamine

Placebo group

Placebo Comparator group

Description:

The placebo group patients will be received 0.9% saline perioperatively.

Treatment:

Drug: 0.9 % saline