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

Not Applicable

Withdrawn

• Conditions: Postoperative Delirium (POD); Postoperative Sleep Disturbance
• Interventions: Drug: Esketamine; Drug: 0.9 % saline

• Registration Number: NCT06900205
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-23
• Study First Submitted QC: 2025-03-23
• Study First Posted: 2025-03-28
• Study Start: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-03-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 644

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esketamine group	Esketamine	The esketamine group patients will be received esketamine perioperatively.
Placebo group	0.9 % saline	The placebo group patients will be received 0.9% saline perioperatively.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative delirium	postoperative 7 day	Postoperative delirium is assessed by the 3-minute diagnostic interview for CAM (3D-CAM) or the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) as applicable.
The incidence of postoperative sleep disturbance	postoperative 3 day	Postoperative sleep disturbance is evaluated by the Athens Insomnia Scale (AIS).; The AIS is a self-rated psychometric questionnaire to quantify sleep difficulties according to the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision criteria.; The AIS consists of 8 items: waking up at night, sleep induction, final awakening, total sleep duration, sleep quality, well-being, functional ability, and daytime sleepiness.; The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.

Secondary Outcome Measures

Name	Time	Method
The incidence of postoperative cognitive dysfunction	7 days after surgery and 90 days after surgery	Postoperative delirium is assessed by the Montreal Cognitive Assessment (MoCA).; MoCA scale was widely identified in the detection of mild cognitive impairment. MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.; The total possible score is 30 points; a score of 26 or above is considered normal.
postoperative pain severity score	2 hours after surgery、postoperative 3 day and 90 days after surgery	The degree of surgical incision pain will be assessed at rest and on movement by Visual Analogue Scale (VAS). VAS ranges from 0 to 10, with the highest score indicating the worst pain.
The incidence of postoperative adverse reactions	postoperative 90 days	Postoperative adverse reactions within 90 days were defined as postoperative adverse reactions that are new, have an adverse effect on the patient, and require medical intervention (including psychiatric system symptoms, 30-day all-cause mortality etc.).

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China