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NCT Number: NCT07665099

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

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.

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Key information

Conditions

Perioperative Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location contact

Guanghui Hao, Master's Candidate

CONTACT

[email protected]

+86 15291285018

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 60 years, either sex; Scheduled for elective oral and maxillofacial surgery under general anesthesia (including oral and maxillofacial tumor surgery, orthognathic surgery, and maxillofacial trauma repair surgery); American Society of Anesthesiologists (ASA) physical status I-III; Expected duration of anesthesia ≥ 2 hours; Willing and able to provide written informed consent.

Exclusion criteria

Pre-existing behavioral disorders or psychiatric diseases (e.g., Alzheimer's disease, Parkinson's disease), or current use of antipsychotic medications (e.g., clozapine, risperidone, olanzapine, haloperidol, chlorpromazine); Pre-existing severe organ dysfunction including: severe cardiovascular disease (life-threatening arrhythmias, severe uncontrolled hypertension, coronary artery disease, heart failure), severe respiratory disease (respiratory failure, severe chronic obstructive pulmonary disease), severe hepatic insufficiency (Child-Pugh Class C), or severe renal insufficiency (glomerular filtration rate < 30 mL/min or creatinine > 2.5 mg/dL); Known contraindications to esketamine including: hypersensitivity to the active substance or any excipients; severe risk of elevated blood pressure or intracranial pressure; uncontrolled or untreated hypertension (resting systolic/diastolic blood pressure > 180/100 mmHg); preeclampsia or eclampsia; untreated or inadequately treated hyperthyroidism; conditions requiring uterine relaxation (e.g., uterine rupture, umbilical cord prolapse); use as the sole anesthetic in patients with significant ischemic heart disease; Surgical approach that would interfere with postoperative MoCA assessment; Concurrent participation in another clinical trial; Pre-existing cognitive impairment or Mini-Mental State Examination (MMSE) score < 24, unable to complete questionnaire-based assessments.

Treatment and study plan

Esketamine

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA) Score on Postoperative Day 1

    Time frame: Day 1 after surgery

    Montreal Cognitive Assessment (MoCA) Score on Postoperative Day 1

Secondary outcomes

  1. Telephone-Montreal Cognitive Assessment (T-MoCA) Score at Postoperative Days 3, 7, and 15

    Time frame: Postoperative days 3, 7, and 15

    The Telephone-Montreal Cognitive Assessment (T-MoCA) is an adapted version of the MoCA designed for telephone administration, removing visual-dependent items. Total scores range from 0 to 22, with higher scores indicating better cognitive function. It will be administered by trained assessors blinded to group allocation at postoperative days 3, 7, and 15 to track cognitive recovery trajectory

  2. Sleep Quality Assessed by Athens Insomnia Scale (AIS) at Postoperative Days 1 and 3

    Time frame: Postoperative days 1 and 3

    The Athens Insomnia Scale (AIS) is an 8-item self-report questionnaire assessing sleep quality over the past 24 hours. Total scores range from 0 to 24, with higher scores indicating worse sleep quality: 0-3 = no insomnia; 4-6 = mild insomnia; 7-10 = moderate insomnia; ≥11 = severe insomnia.

  3. Pain Intensity Measured by Visual Analog Scale (VAS) at Postoperative Hours 6, 12, and 24

    Time frame: Postoperative hours 6, 12, and 24

    The Visual Analog Scale (VAS) is a 10-cm horizontal line anchored by "no pain" at 0 and "worst imaginable pain" at 10. Patients mark their current pain level, and the distance from 0 is measured in millimeters. Scores range from 0 to 10, with higher scores indicating more severe pain.

  4. Emotional Status Assessed by Hospital Anxiety and Depression Scale (HADS) at Postoperative Days 1 and 3

    Time frame: Postoperative days 1 and 3

    The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire with two subscales: anxiety (7 items) and depression (7 items). Each item is scored 0-3, with subscale scores ranging from 0 to 21. Higher scores indicate worse mood disturbance. Scores ≥11 on either subscale indicate clinically significant symptoms.

  5. Incidence of Rescue Analgesia

    Time frame: During the first 24 hours after surgery

    Rescue analgesia is defined as the administration of patient-controlled analgesia (PCA) pump when postoperative VAS score reaches ≥4. The incidence will be recorded and compared between groups

  6. serological indicators

    Time frame: Baseline (1 day before surgery) and 24 hours after surgery

    Peripheral venous blood samples (3 mL) will be collected at baseline (1 day before surgery) and at 24 hours after surgery. Serum levels of inflammatory cytokine interleukin-6 (IL-6), neuronal injury marker S100β protein, brain-derived neurotrophic factor (BDNF), and neurofilament light chain (NfL) will be measured using enzyme-linked immunosorbent assay (ELISA). Correlations between biomarker changes and cognitive outcomes will be explored.

  7. incidence of adverse reactions

    Time frame: From study drug administration to 24 hours after surgery

    Adverse events will be monitored from drug administration to 24 hours post-surgery, including: blood pressure fluctuations (MAP change >20% from baseline), heart rate changes (HR >100 bpm or <50 bpm), psychiatric symptoms (hallucinations, dizziness, somnolence), and gastrointestinal reactions (nausea, vomiting with PONV impact scale ≥1). All adverse events will be recorded and compared between groups

Study contacts

Contact information is provided by the study sponsor or research team.

Guanghui Hao

CONTACT

[email protected]

+8615291285018

Haopeng Zhang

CONTACT

[email protected]

+86 17791305967

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Effect of Esketamine on Postoperative Cognitive Function in Elderly Patients Undergoing Oral and Maxillofacial Surgery: A Prospective, Randomized, Double-Blind, Placebo-Controlled Parallel Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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