Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

18 juni 2026 uppdaterad av: Zhang Haopeng, Xijing Hospital

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

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

98

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Kina
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710032
        • The Third Affiliated Hospital of Air Force Medical University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Esketamine Group
Participants in this arm will receive an intravenous bolus of esketamine 0.3 mg/kg (administered over 1 minute) after anesthesia induction, followed by a continuous infusion of 0.3 mg/kg/h, which will be discontinued 30 minutes before the end of surgery. The drug will be prepared in normal saline to a total volume of 10 mL and administered in a double-blind manner
Läkemedel: 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
Placebo-jämförare: Normal Saline Group
Participants in this arm will receive an equal volume of normal saline at the same time points as the experimental group: a bolus after anesthesia induction followed by a continuous infusion, which will be discontinued 30 minutes before the end of surgery. The placebo will be prepared in identical syringes to maintain blinding
Läkemedel: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Montreal Cognitive Assessment (MoCA) Score on Postoperative Day 1
Tidsram: Day 1 after surgery
Montreal Cognitive Assessment (MoCA) Score on Postoperative Day 1
Day 1 after surgery

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Xijing Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

15 januari 2027

Avslutad studie (Beräknad)

31 januari 2027

Studieregistreringsdatum

Först inskickad

18 juni 2026

Först inskickad som uppfyllde QC-kriterierna

18 juni 2026

Första postat (Faktisk)

24 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KQ-YJ-2026-193
  • 82271231 (Annat bidrag/finansieringsnummer: National Natural Science Foundation of China)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera