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临床试验/NCT06389045
NCT06389045已完成不适用

Effect of Propofol Infusion-Based Sedation on Anesthesia-Related Adverse Events in Endoscopic Ultrasonography: A Prospective Observational Study

Samsun University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Anesthesia related advers events

研究概览

简要总结

Endoscopic ultrasonography (EUS) is an endoscopic procedure performed to investigate conditions affecting the stomach, liver, and bile ducts, as well as for therapeutic interventions. The complexity of EUS can vary significantly, with increased complexity affecting procedure duration, technical success, and the occurrence of adverse events. For the comfort of patients and the success of the procedure, these interventions are typically performed under anesthesia with procedural sedation. To enhance the success rate of the procedure, reduce the risk of side effects, and maximize patient comfort, EUS is generally performed under sedation according to the recommendations of the American Society of Anesthesiologists (ASA). During sedation, the aim is for the patient to be more relaxed and comfortable while maintaining spontaneous respiratory function. Preserving spontaneous respiratory parameters is crucial for procedural safety.

详细描述

Within the scope of this study, patients undergoing endoscopic ultrasonography (EUS) under anesthesia in the endoscopy unit will be examined. We administered propofol infusion for procedural sedation for patients undergoing therapeutic EUS in our hospital's endoscopy unit. We aimed to evaluate the impact of this sedation method on anesthesia-related adverse events. The primary outcome of this study was to evaluate the anesthesia-related adverse events, which were defined as arrhythmia, hypotension, desaturation, vomiting, undesirable patient movement, coughing, and hiccups during EUS probe insertion. The secondary outcome was defined as the patient's recovery time from anesthesia. In addition, bolus/infusion drug doses used for anesthesia induction and maintenance, demographic data, EUS indications in patients, and comorbidities of patients were recorded.

Vital parameters will be recorded during the procedure and in the recovery unit. Data for the study will be obtained from nurse observation forms and anesthesia records found in patient files. It is an observational study of file scanning nature, which includes information contained in the files.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Endoscopic ultrasonography (EUS) patients for procedural sedation

排除标准

  • Patients who do not sign the consent form.
  • Under the age of
  • Pregnancy.

结局指标

主要结局

Anesthesia related advers events

时间窗: during the procedure

arrhythmia, hypotension, desaturation, vomiting, patient movement, cough during EUS probe insertion, hiccups

次要结局

  • recovery time(1 hour)

研究者

发起方
Samsun University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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