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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127025
Enrollment
Unknown
Registered
2026-06-23
Start date
2026-06-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Neurocognitive Disorders

Interventions

Esketamine group:Anesthesia induction was followed by intravenous injection of esketamine 0.3 mg·kg-1 (injected over >1 min), which was maintained at 0.3 mg·kg-1·h-1 until 30 min before the end of sur
Control group:Intravenous injection of equal volume normal saline at the same time point with identical maintenance dosage

Sponsors

Department of Anesthesiology, The Third Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 60 or older, any gender; 2. Patient agrees to participate in this trial and signs the informed consent form; 3. Scheduled to undergo oral and maxillofacial surgery under general anesthesia (including oral and maxillofacial tumor surgery, orthognathic surgery, maxillofacial trauma repair surgery); 4. American Society of Anesthesiologists (ASA) classification I-III (excluding patients with serious underlying diseases to reduce medication risks); 5. Expected anesthesia duration of 2 hours or more

Exclusion criteria

Exclusion criteria: 1. Preoperative behavioral disorders or coexisting psychiatric conditions (Alzheimer's or Parkinson's), using psychiatric medications (clozapine, risperidone, olanzapine, haloperidol, chlorpromazine, etc.) 2. Preoperative coexisting major organ dysfunction: severe cardiovascular diseases (serious arrhythmias affecting circulation, severe and hard-to-control hypertension, coronary heart disease, heart failure), severe respiratory diseases (respiratory failure, severe chronic obstructive pulmonary disease), severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (glomerular filtration rate 2.5 mg/dL) 3. Contraindications for esketamine use: patients allergic to the active ingredient or any excipients; patients at high risk for severe hypertension or increased intracranial pressure; uncontrolled or untreated hypertension (arterial hypertension, resting systolic/diastolic >180/100 mmHg); preeclampsia and eclampsia; untreated or inadequately treated hyperthyroidism; situations requiring uterine muscle relaxation, such as uterine rupture or umbilical cord prolapse; used as the sole anesthetic in patients with significant ischemic heart disease 4. Surgical methods affect postoperative MoCA assessment 5. Participation in other clinical studies 6. Cognitive impairment or preoperative MMSE score <24, unable to cooperate with the questionnaire

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment (MoCA) score;

Secondary

MeasureTime frame
Telephone Montreal Cognitive Assessment (T-MoCA) score;Athens Insomnia Scale (AIS) score;Hospital Anxiety and Depression Scale (HADS) score;Visual Analogue Scale (VAS) score;serological indicators;incidence of rescue analgesia;incidence of adverse reactions;

Countries

China

Contacts

Public ContactZhang Haopeng

The Third Affiliated Hospital of Air Force Medical University

haopeng.zhang@foxmail.com+86 177 9130 5967

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026