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临床试验/NCT04399226
NCT04399226已完成不适用

Efficacy and Safety of Deksmedetomidine-propofol or Ketamine-propofol

Yuzuncu Yıl University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月18日最近更新:
适应症
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
60
试验地点
1
主要终点
Demographic data

研究概览

简要总结

Sedation with dexmedetomidine-propofol or ketamine-propofol was planned in patients with upper gastrointestinal endoscopy.

详细描述

Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II groups were included. Patients that had severe organ disease, allergies to study drugs, refused to participate in the study were excluded. Cases were randomized into the dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30). Cardiac monitoring, peripheral oxygen saturation, bispectral index (BIS) monitoring were performed. Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine). Patients were followed up with a Ramsay Sedation Scale (RSS) of≥4. Mean, standard deviation, mean, lowest-highest frequency and ratio values were used in descriptive statistics of the data, SPSS 22.0 program was used for the analyses.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-II group
  • 60 patients
  • between the ages of 18 and 60
  • planned to have upper gastrointestinal system (UGIS) endoscopy with sedation,

排除标准

  • severe heart, lung, liver disease
  • kidney failure,
  • bleeding diathesis
  • infection,
  • electrolyte disorder such as hypokalemia, hypocalcaemia, acid-base disorder, hypothermia, allergy to drugs to be used, and study those who refused to be included were excluded

结局指标

主要结局

Demographic data

时间窗: 2 minutes

no difference

次要结局

  • adverse events(2 minutes)

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arzu Esen Tekeli

Assistant Professor

Yuzuncu Yıl University

研究点 (1)

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