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临床试验/NCT02651792
NCT02651792已完成2 期

Ketamine-propofol Versus Pethidine-propofol for Sedating Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
1
主要终点
endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)

研究概览

简要总结

The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction.

详细描述

The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to <90% , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation scores of all patients will be recorded perioperatively. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • both gender
  • age between 18-70

排除标准

  • pregnant patients.
  • morbid obesity.
  • chronic obstructive pulmonary disease.
  • complicated airway.
  • American society of anesthesia (ASA) physical classification IV-V.
  • history of allergy or contraindications to the drugs used in the study
  • emergency need for ERCP.
  • those whose informed consent could not be signed.
  • those with possible complex ERCP.

研究组 & 干预措施

ketamine- propofol

Active Comparator

IV Ketamine 1mg/kg + Propofol 1.2 mg/kg will be given for sedation.

干预措施: ketamine- propofol (Drug)

pethidine- propofol

Active Comparator

1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction

干预措施: pethidine- propofol (Drug)

结局指标

主要结局

endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)

时间窗: Immediately after procedure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

khaled salah mohamed

lecturer of anaesthesia and ICU

Assiut University

研究点 (1)

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