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The Effect of Esketamine on Postoperative Cognitive Function in Elderly Patients Undergoing Oral and Maxillofacial Surgery

NCT07665099 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-06-24

No results posted yet for this study

Summary

Esketamine is a common anesthetic adjuvant. Previous studies have shown that it may have protective effects on the brain. This study aims to investigate whether esketamine can improve cognitive function recovery in elderly patients (aged 60 years and older) undergoing oral and maxillofacial surgery.

Participants will be randomly assigned to receive either esketamine or a placebo (normal saline) during anesthesia. Neither the participants nor the researchers will know which treatment is given.

Cognitive function will be assessed using standardized tests before surgery and at 1, 3, 7, and 15 days after surgery. Sleep quality, pain scores, emotional status, and adverse events will also be recorded. Blood samples will be collected to explore potential mechanisms.

The study is expected to enroll approximately 98 participants at the Third Affiliated Hospital of Air Force Medical University in Xi'an, China. Participation will last about 16 days from the day before surgery to the final follow-up on day 15 after surgery.

Conditions

  • Perioperative Neurocognitive Disorders

Interventions

DRUG

esketamine

Esketamine is administered as an intravenous bolus of 0.3 mg/kg (over 1 minute) after anesthesia induction, followed by a continuous intravenous infusion of 0.3 mg/kg/h until 30 minutes before the end of surgery. The drug is diluted with normal saline to a total volume of 10 mL and prepared in identical syringes to ensure blinding. This intervention is used as the experimental treatment to assess its effect on postoperative cognitive recovery in elderly patients undergoing oral and maxillofacial surgery

DRUG

Normal Saline

Normal saline is used as the placebo control. It is administered as an intravenous bolus of equal volume after anesthesia induction, followed by a continuous intravenous infusion at an equal rate until 30 minutes before the end of surgery. The saline is prepared in identical syringes to the experimental drug to maintain double-blind conditions. This intervention serves as the comparator to evaluate the specific effect of esketamine on postoperative cognitive recovery

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-01-15
Completion
2027-01-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07665099 on ClinicalTrials.gov