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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Delirium (POD) Postoperative Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Drug: Esketamine After anesthesia induction intubation and before surgery,0.25mg/kg esketamine will be diluted into a 10ml syringe and injected intravenously.

After surgery,a postoperative intravenous analgesia pump will be given with the following drugs and dosages:sufentanil 1.5ug/kg,esketaminge 1.0mg/kg and tolansetron 5mg, diluted into100ml at 2ml/h for 48h.

Drug: 0.9% saline After anesthesia induction intubation and before surgery,10ml of 0.9% saline will be injected intravenously.

After surgery,a postoperative intravenous analgesia pump will be given with the following drugs and dosages:sufentanil 1.5ug/kg and tolansetron 5mg, diluted into100ml at 2ml/h for 48h.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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esketamine group

The esketamine group patients will be received esketamine perioperatively.

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

loading dose:intravenous infusion of 0.25mg/kg esketamine after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail+1mg/kg esketamine diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h.

Placebo group

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

Group Type PLACEBO_COMPARATOR

0.9 % saline

Intervention Type DRUG

loading dose:intravenous infusion the same volume of 0.9% saline as the other group after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h.

Interventions

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Esketamine

loading dose:intravenous infusion of 0.25mg/kg esketamine after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail+1mg/kg esketamine diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h.

Intervention Type DRUG

0.9 % saline

loading dose:intravenous infusion the same volume of 0.9% saline as the other group after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No