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

May 13, 2025 updated by: RenJi Hospital

Effects of Esketamine on the Incidence of Postoperative Delirium and Postoperative Sleep Disturbance in Elderly Patients After Major Non-cardiac Surgery: A Multi-Center Randomized Controlled Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: esketamine group
The esketamine group patients will be received esketamine perioperatively.
Drug: 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.
Placebo Comparator: Placebo group
The placebo group patients will be received 0.9% saline perioperatively.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative delirium
Time Frame: 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.
postoperative 7 day
The incidence of postoperative sleep disturbance
Time Frame: 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.
postoperative 3 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative cognitive dysfunction
Time Frame: 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.
7 days after surgery and 90 days after surgery
postoperative pain severity score
Time Frame: 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.
2 hours after surgery、postoperative 3 day and 90 days after surgery
The incidence of postoperative adverse reactions
Time Frame: 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.).
postoperative 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Shanghai Chest Hospital
Shanghai Xuhui Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 23, 2025

First Submitted That Met QC Criteria

March 23, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol and de-identified individual participant data could be shared after 1 year after publication with the permission of principle investigator for reasonable usage.

IPD Sharing Time Frame

The data could be shared after 1 year after publication with the permission of principle investigator. The duration of the data sharing will be determined by principle investigator after publication.

IPD Sharing Access Criteria

Study protocol and de-identified individual participant data could be shared after 1 year after publication with the permission of principle investigator. Please email principle investigator if researchers wish to have the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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