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

Official 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

Overview

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.

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
• 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

Primary outcome measures

• Montreal Cognitive Assessment (MoCA) Score on Postoperative Day 1 [Time frame: Day 1 after surgery]

Secondary outcome measures (7)

• Telephone-Montreal Cognitive Assessment (T-MoCA) Score at Postoperative Days 3, 7, and 15 [Time frame: Postoperative days 3, 7, and 15]
• Sleep Quality Assessed by Athens Insomnia Scale (AIS) at Postoperative Days 1 and 3 [Time frame: Postoperative days 1 and 3]
• Pain Intensity Measured by Visual Analog Scale (VAS) at Postoperative Hours 6, 12, and 24 [Time frame: Postoperative hours 6, 12, and 24]
• Emotional Status Assessed by Hospital Anxiety and Depression Scale (HADS) at Postoperative Days 1 and 3 [Time frame: Postoperative days 1 and 3]
• Incidence of Rescue Analgesia [Time frame: During the first 24 hours after surgery]
• serological indicators [Time frame: Baseline (1 day before surgery) and 24 hours after surgery]
• incidence of adverse reactions [Time frame: From study drug administration to 24 hours after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

China · 1 center

• The Third Affiliated Hospital of Air Force Medical University — Xi'an

Identifiers

NCT: NCT07665099 · KQ-YJ-2026-193 · 82271231

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗