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临床试验/NCT03607110
NCT03607110已完成不适用

Comparison of Ketamine-propofol Sedation Protocols With Fentanyl-propofol Administered by Endoscopist or Anesthesiologist at Colonoscopy

Selda KAYAALTI1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年3月1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
120
试验地点
1
主要终点
pain level - VAS SCALE

研究概览

简要总结

In sedation applications performed by an endoscopist or anesthetist during colonoscopy, it was investigated whether there were differences in pain levels evaluated by VAS (Visuel analog scale), patient satisfaction, duration of procedure and side effects

详细描述

Gastrointestinal endoscopes are an invasive and unpleasant procedure that is increasingly being performed worldwide (1). Colonoscopy; is one of the endoscopic procedures that can be used to diagnose and treat large intestine and cause pain and excessive discomfort in the patient (2). For this reason, intravenous (iv) sedative agents are used in endoscopy centers where endoscopy will be performed. However, side effects such as hypoxia and hypotension, which are usually dose-dependent, caused by these sedative agents, play an important role among risk factors associated with colonoscopy (3). For this reason, the use of propofol as an anesthetic is prohibited in some countries, which is a commonly used agent for sedation. However, the presence of an anesthetist during each endoscopy procedure is difficult because there are not enough anesthetists. This application is also more costly. For this reason, studies have been carried out during the gastrointestinal endoscopy when sedation is delivered by someone other than the anesthetist (4). For this purpose, several studies comparing patient-controlled sedation or sedation applied by an endoscopist to sedation performed by anesthesiologist were performed (4, 5). Investigators aimed to investigate whether there is any difference between the two groups in terms of pain levels assessed by VAS (Visuel analog scale) and patient satisfaction by comparing sedation protocols applied by endoscopist or anesthesist during colonoscopy in this study.

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

  • Patients who accept the method and will undergo elective colonoscopy
  • ASA I-II group
  • Patients with the ability to perform VAS scoring

排除标准

  • Patients who do not accept the method
  • ASA III-IV-V group of patients with uncontrolled chronic disease (such as uncontrolled hypertension, uncontrolled diabetes mellitus)
  • Patients with severe respiratory failure and cardiovascular disease
  • Patients with liver and kidney failure
  • Patients with long-term analgesic, opioid, sedative use history - Patients who are known to be hypersensitive to study medications, eggs,
  • Those who are of pregnancy or pregnancy and those who are in breastfeeding period
  • Those with antipsychotic or antidepressant medication usage

研究组 & 干预措施

ketamine

ketamine used

干预措施: Ketamine (Drug)

ketamine

ketamine used

干预措施: patient control analgesia (Device)

fentanyl

fentanyl used

干预措施: fentanyl (Drug)

fentanyl

fentanyl used

干预措施: patient control analgesia (Device)

结局指标

主要结局

pain level - VAS SCALE

时间窗: during the operation

Pain level assessed by VAS

patient satisfaction - Patient satisfaction Scale

时间窗: during the operation

patient satisfaction assessed by with satisfaction score of 4 points-scale (1 very good, 2 good, 3 not bad, 4 bad)

次要结局

  • operation time(during the operation)
  • side effects questionnaire(during the operation)

研究者

发起方
Selda KAYAALTI
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Selda KAYAALTI

Anesthesia and Reanimation Specialist

Develi Devlet Hastanesi

研究点 (1)

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