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临床试验/NCT05466279
NCT05466279已完成不适用

Department of Anesthesiology, Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital), Research Center for Neuro-Oncology Interaction , Institute of Basic Medicine and Cancer, Chinese Academy of Sciences.

Fang Jun1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2021年1月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
131
试验地点
1
主要终点
Incidence of postoperative delirium

研究概览

简要总结

This study is a prospective, randomized, controlled trial.The selected patients were randomly divided into remazolam general anesthesia group and propofol + midazolam general anesthesia control group according to computer randomization method. There were 65 patients in each group. Remazolam general anesthesia group (R group): Remazolam 0.4 mg/kg for rapid induction of loss of consciousness for anesthesia induction and 1 mg/kg/h for maintenance. Propofol + midazolam general anesthesia control group (group P): propofol 1.5 mg/kg + midazolam 0.05 mg/kg slow intravenous push until the patient's consciousness disappeared, then propofol 4-8 mg/kg/h Anesthesia was maintained. Except for different sedative drugs, the analgesic and muscle relaxant medication regimens were the same between the two groups. In the study, the application of inhaled anesthetics, other benzodiazepines and anticholinergic drugs was restricted, and the mean arterial pressure during the operation was kept above 60 mmHg to avoid perioperative hypotension, hypoxemia, and hypercapnia. Warm measures were used to maintain the patient's intraoperative body temperature above 36.0 °C. POD assessment was performed on the day before surgery and on days 1-7 after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly patients with limited abdominal tumor surgery (age ≥65 years)
  • ASA classification I-III.

排除标准

  • Refusing to participate in the study
  • Patients with severe arrhythmia or cardiac dysfunction (EF<35%)
  • A clear history of neurological and psychiatric disorders before surgery or long-term use of sedatives or antidepressants
  • History of alcoholism or drug dependence
  • History of brain surgery or trauma
  • Severe vision or hearing impairment
  • Inability to cooperate with the completion of cognitive function tests

研究组 & 干预措施

Remazolam general anesthesia group (R group)

Experimental

干预措施: remazolam (Drug)

Propofol + midazolam general anesthesia control group (group P)

Active Comparator

干预措施: Propofol (Drug)

Propofol + midazolam general anesthesia control group (group P)

Active Comparator

干预措施: Midazolam (Drug)

结局指标

主要结局

Incidence of postoperative delirium

时间窗: Postoperative, 7 days

Proportion of patients with postoperative delirium among enrolled patients. The incidence of delirium during recovery was assessed by the Confusion Assessment Method-ICU (CAM-ICU). The assessment time points were: 10 minutes, 30 minutes after entering the anesthesia recovery room (or exiting the recovery room). The incidence of delirium within 7 days after surgery was assessed using 3D-CAM to assess whether patients had delirium.

次要结局

  • Intraoperative awareness rate(Postoperative, 24 hours)
  • Intraoperative hemodynamic stability(Intraoperative, 6 hours)
  • Richard-campbell Sleep Questionnaire Score(Postoperative, 3 days)
  • Perioperative nutritional status score table(PONS)(Baseline, 1 year)
  • Modified frailty rating scale(Baseline, 1 year)
  • Postoperative nausea and vomiting(Postoperative, 7 days)
  • Postoperative hospital stay(Postoperative, 3 months)

研究者

发起方
Fang Jun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fang Jun

Clinical Professor

Zhejiang Cancer Hospital

研究点 (1)

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