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临床试验/NCT06719960
NCT06719960已完成不适用

How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Endoscopic Retrograde Cholangiopancreatography Patients?

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2023年7月20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
入组人数
184
试验地点
1
主要终点
Assesment of cognitive function

研究概览

简要总结

The investigators wanted to observe the change in the level of consciousness of patients undergoing ERCP after anesthesia. For this, the investigators evaluated the patients with the mini mental state examination test and the frail scale.

详细描述

Background and Aim: For patients, endoscopic retrograde cholangiopancreatography (ERCP) is a painful procedure and requires deeper sedation and less body movement than routine gastrointestinal endoscopy. Different sedation methods can be used during the ERCP procedure, which is increasingly used in elderly patients, but their effects on cognitive functions are not clearly known. The main aim of our study was to observe the effect of different sedation methods routinely used in geriatric ERCP patients on cognitive functions.

Methods: Our observational prospective study included 184 inpatients aged 65 years and older who received propofol or propofol + dexmedetomidine for sedation during ERCP. To evaluate cognitive function, Mini Mental State Examination (MMSE) was administered 3 times before the procedure and 2 hours and 24 hours after the procedure. Frailty level of the patient was determined using the frail frailty questionnaire. Each patient received 0.5µg/kg fentanyl (iv). In the propofol group, propofol loading dose: 0.2-0.5mg/kg, maintenance infusion dose: 0.5-4mg/kg/h was continued. In the dexmedetomidine group, in addition to propofol infusion at the same doses, dexmedetomidine 0.5 μg/kg-1 loading dose was administered within 10 minutes and then continued as infusion at a dose of 0.2-0.7 μg/kg/h. Ramsey score was kept at 3-4. ERCP procedure time, total amount of propofol and dexmedetomidine used, atropine and ephedrine administered additionally were recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Patients aged 65 years older and who underwent ERCP and were hospitalized were included in the study.

排除标准

  • Patients with 2nd and 3rd degree Atrioventricular Block,
  • Recent history of stroke
  • Severe hypotensive
  • Cardiorespiratory instability
  • Substance abuse
  • Psychotic illness
  • Severe dementia

研究组 & 干预措施

Propofol

aged 65 years and older who received propofol

干预措施: Propofol group (Drug)

Dexmedetomidine

aged 65 years and older who received propofol + dexmedetomidine

干预措施: Dexmedetomidine group (Drug)

结局指标

主要结局

Assesment of cognitive function

时间窗: Maximum 1 day (Mini Mental State Examination scores can be between 0-30. Less than 10 is considered severe impairment, 10-19 is considered moderate dementia, 19-24 is considered early dementia and 25 and above is considered normal)

Evaluating patients with Mini Mental State Examination (MMSE). Cognitive disfunctions are recorded

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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