NCT07523334

Brief Summary

Esketamine is frequently used during the perioperative period for supplemental analgesia. Small sample size trials showed that subanesthetic dose esketamine may decrease postoperative neurocognitive complications. However, conflicting results exist and optimal dose of esketamine remains to be determined. This dose-exploring pilot trial is designed to evaluate the safety and efficacy of three different perioperative esketamine dosing regimens in older patients undergoing major non-cardiac surgery. The primary purpose is to explore the optimal dosing strategy that produce maximal neurocognitive benefits with minimal adverse neuropsychiatric symptoms.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
5mo left

Started Apr 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Apr 2026Dec 2026

Study Start

First participant enrolled

April 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 4, 2026

Last Update Submit

April 9, 2026

Conditions

ElderlyNoncardiac SurgeryDelayed Neurocognitive RecoveryPostoperative DeliriumEsketamine

Keywords

Older patientsNoncardiac surgeryDelayed neurocognitive recoveryPostoperative deliriumEsketamine

Outcome Measures

Primary Outcomes (1)

  • Incidence of dissociative symptoms

    Dissociative symptoms will be assessed at 30 minutes after extubation and then twice daily (8:00-10:00, 18:00-20:00) during the first 4 days after surgery, using the 6-item Clinician Administered Dissociative State Scale (CADSS-6; scores range frrom 0 to 24 with higher scores indicating more severe dissociative symptoms; a score \>=3 indicates presence of dissociative symptoms).

    Up to 4 days after surgery

Secondary Outcomes (3)

  • Incidence of emergence delirium

    At 30 minutes after extubation

  • Incidence of postoperative delirium

    Up to 4 days after surgery

  • Incidence of delayed neurocognitive recovery

    Up to 5 days after surgery

Other Outcomes (8)

  • Area under curve of dissociative symptom severity at various timepoints after surgery

    Up to 4 days after surgery

  • Area under curve of pain intensity at various timeoints after surgery

    Up to 4 days after surgery

  • Scores of subjective sleep quality after surgery

    Up to 4 days after surgery

  • +5 more other outcomes

Study Arms (4)

Esketamine dose 1

EXPERIMENTAL

During anesthesia, a loading dose esketamine (0.5 mg/ml) 0.4 ml/kg will be infused over 30 minutes (0.1 mg/kg) after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h (0.05 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with esketamine (0.25 mg/ml) and sufentanil (1 ug/ml), programmed to deliver 2-ml bolus (0.5 mg esketamine) with a 8-10-minute lock-out time and a 1-ml/h (0.25 mg/h esketamine) background infusion, and used for up to 48 hours.

Drug: Esketamine 1

Esketamine dose 2

EXPERIMENTAL

During anesthesia, a loading dose esketamine (1 mg/ml) 0.4 ml/kg will be infused over 30 minutes (0.2 mg/kg) after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h (0.1 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with esketamine (0.5 mg/ml) and sufentanil (1 ug/ml), programmed to deliver 2-ml bolus (1 mg esketamine) with a 8-10-minute lock-out time and a 1-ml/h (0.5 mg/h esketamine) background infusion, and used for up to 48 hours.

Drug: Esketamine 2

Esketamine dose 3

EXPERIMENTAL

During anesthesia, a loading dose esketamine (1.5 mg/ml) 0.4 ml/kg will be infused over 30 minutes (0.3 mg/kg) after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h (0.15 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with esketamine (0.75 mg/ml) and sufentanil (1 ug/ml), programmed to deliver 2-ml bolus (1.5 mg esketamine) with a 8-10-minute lock-out time and a 1-ml/h (0.75 mg/h esketamine) background infusion, and used for up to 48 hours.

Drug: Esketamine 3

Placebo

PLACEBO COMPARATOR

During anesthesia, a loading dose placebo (normal saline) 0.4 ml/kg will be infused over 30 minutes after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with sufentanil (1 ug/ml), programmed to deliver 2-ml bolus with a 8-10-minute lock-out time and a 1-ml/h background infusion, and used for up to 48 hours.

Drug: Normal saline

Interventions

Normal salineDRUG

During anesthesia, a loading dose placebo (normal saline) 0.4 ml/kg will be infused over 30 minutes after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with sufentanil (1 ug/ml), programmed to deliver 2-ml bolus with a 8-10-minute lock-out time and a 1-ml/h background infusion, and used for up to 48 hours.

Also known as: Placebo
Placebo
Esketamine 1DRUG

During anesthesia, a loading dose esketamine (0.5 mg/ml) 0.4 ml/kg will be infused over 30 minutes (0.1 mg/kg) after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h (0.05 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with esketamine (0.25 mg/ml) and sufentanil (1 ug/ml), programmed to deliver 2-ml bolus (0.5 mg esketamine) with a 8-10-minute lock-out time and a 1-ml/h (0.25 mg/h esketamine) background infusion, and used for up to 48 hours.

Also known as: Esketamine dose 1
Esketamine dose 1
Esketamine 2DRUG

During anesthesia, a loading dose esketamine (1.0 mg/ml) 0.4 ml/kg will be infused over 30 minutes (0.2 mg/kg) after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h (0.1 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with esketamine (0.5 mg/ml) and sufentanil (1 ug/ml), programmed to deliver 2-ml bolus (1 mg esketamine) with a 8-10-minute lock-out time and a 1-ml/h (0.5 mg/h esketamine) background infusion, and used for up to 48 hours.

Also known as: Esketamine dose 2
Esketamine dose 2
Esketamine 3DRUG

During anesthesia, a loading dose esketamine (1.5 mg/ml) 0.4 ml/kg will be infused over 30 minutes (0.3 mg/kg) after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h (0.15 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with esketamine (0.75 mg/ml) and sufentanil (1 ug/ml), programmed to deliver 2-ml bolus (1.5 mg esketamine) with a 8-10-minute lock-out time and a 1-ml/h (0.75 mg/h esketamine) background infusion, and used for up to 48 hours.

Also known as: Esketamine dose 3
Esketamine dose 3

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged \>=65 but \<= 90 years;
  • Scheduled to undergo non-cardiac surgery with an expected duration of \>= 2 hours under general anesthesia;
  • Requiring patient-controlled intravenous analgesia (PCIA) after surgery.

You may not qualify if:

  • Unable to communicate preoperatively due to visual or auditory impairment, language barrier, or severe dementia;
  • Comorbid with schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
  • Traumatic brain injury or neurosurgery;
  • Severe hepatic dysfunction (Child-Pugh Class C), severe renal dysfunction (receiving dialysis preoperatively), or American Society of Anesthesiologists physical status classification \>= â…£;
  • Expected admission to the Intensive Care Unit with endotracheal intubation after surgery;
  • Anaphylaxis to esketamine;
  • Participation in other clinical studies, or any other conditions that are considered unsuitable to be involved in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Tianjin Medical University General Hospital

Tanjing, Tianjing, 300052, China

Location

Related Publications (38)

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MeSH Terms

Conditions

Emergence Delirium

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Dong-Xin Wang, MD, PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

+86 13910731903wangdongxin@hotmail.com

Jia-Hui Ma, PhD

CONTACT

mjh@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman, Department of Anaesthesiology

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)