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
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Haopeng Zhang
- Número de telefone: +86 17791305967
- E-mail: haopeng.zhang@foxmail.com
Estude backup de contato
- Nome: Guanghui Hao
- Número de telefone: +8615291285018
- E-mail: 15291285018@163.com
Locais de estudo
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- The Third Affiliated Hospital of Air Force Medical University
-
Contato:
- Guanghui Hao, Master's Candidate
- Número de telefone: +86 15291285018
- E-mail: 15291285018@163.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
|
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
|
|
Comparador de Placebo: 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
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) Score on Postoperative Day 1
Prazo: Day 1 after surgery
|
Montreal Cognitive Assessment (MoCA) Score on Postoperative Day 1
|
Day 1 after surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Telephone-Montreal Cognitive Assessment (T-MoCA) Score at Postoperative Days 3, 7, and 15
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KQ-YJ-2026-193
- 82271231 (Número de outro subsídio/financiamento: National Natural Science Foundation of China)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .