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Not yet recruitingPhase 4

Impact of Esketamine on Delayed Neurocognitive Recovery in Older Patients

Key facts

Who runs it
Peking University First Hospital
Where
China2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
Phase
Phase 4
People taking part
120 people, planned
Started
Apr 2026
Expected to end
Dec 2026
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Esketamine 1
  • Esketamine 2
  • Esketamine 3
  • Normal saline
Record updated
14 April 2026

Who can take part

Age
65 years to 90 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Severe hepatic dysfunction (Child-Pugh Class C), severe renal dysfunction (receiving dialysis preoperatively), or American Society of Anesthesiologists physical status classification >= Ⅳ
  • Expected admission to the Intensive Care Unit with endotracheal intubation after surgery
  • 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
  • Participation in other clinical studies, or any other conditions that are considered unsuitable to be involved in the study
  • Traumatic brain injury or neurosurgery
  • Anaphylaxis to esketamine

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 65 and 90 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Esketamine dose 1Treatment being tested

    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.

    Treatment: Esketamine 1

  • Esketamine dose 2Treatment being tested

    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.

    Treatment: Esketamine 2

  • Esketamine dose 3Treatment being tested

    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.

    Treatment: Esketamine 3

  • PlaceboPlacebo, for comparison

    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.

    Treatment: Normal saline

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact of Esketamine on Delayed Neurocognitive Recovery in Older Patients Undergoing Non-cardiac Surgery: a Two-center, Dose-exploring Pilot Trial
Fit questions
Built from NCT07523334, who can take part
Record updated
14 April 2026