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临床试验/NCT04473846
NCT04473846Unknown不适用

The Use of Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures: a Prospective Study

University of Jordan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Recovery time

研究概览

简要总结

Conscious sedation provides adequate control of pain and anxiety for the majority of routine endoscopic procedures as well as adequate amnesia. Sedation practices vary widely, with some colonoscopists advocating sedation only for the most difficult cases of colonoscopy, while others prefer using deep sedation or general anaesthesia for colonoscopy. However, many physicians are still using moderate sedation for the majority of patients.

The use of propofol, a short acting anesthetic agent, for conscious sedation provides a considerably more rapid onset of action and shorter recovery time, for which it is believed to be a safe drug of choice for patients undergoing endoscopic procedures. Although propofol cannot be used as a single agent for moderate sedation, it can be effectively titrated to moderate sedation after administration of small doses of narcotics and sedatives.

The aim of this study is to compare between general anesthesia and deep sedation using propofol-fentanyl-ketamine (PFK) preparation in terms of perioperative vital signs, intraoperative awareness, post-operative pain scores, and the use of analgesia postoperatively.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • patients who were admitted for endoscopic and colonoscopic procedures.
  • ASA (American Society of Anaesthesiologists physical status) score from 1 to 3.

排除标准

  • patient refusal.
  • urgent and emergency cases, which were not elective procedures.
  • Surgeries that were expected to take a long duration (more than 1.5 hour).

研究组 & 干预措施

PF group

Experimental

The first group will undergo general anesthesia using Fentanyl and Propofol.

干预措施: PK general anesthesia (Drug)

PFK group

Experimental

The second group will receive a mixture that consists of Fentanyl, Propofol, and Ketamine. In addition, Lidocaine will be added to reduce the pain on injection caused by Propofol.

干预措施: PFK combination (Drug)

结局指标

主要结局

Recovery time

时间窗: 2 hours

the investigators will document recovery time in the post anesthesia care unit (PACU) until recovery of full consciousness.

Transient decrease in oxygen saturation

时间窗: 1 hour

the investigators will record any episodes of transient reduction of oxygen saturation.

Blood pressure stability

时间窗: 1 hour

the investigators will record changes in blood pressure after induction of anesthesia

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

Abdelkarim Saleh AlOweidi

Principal Investigator

University of Jordan

研究点 (1)

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