The Use of Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures: a Prospective Study
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
- 是
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
The first group will undergo general anesthesia using Fentanyl and Propofol.
干预措施: PK general anesthesia (Drug)
PFK group
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
Abdelkarim Saleh AlOweidi
Principal Investigator
University of Jordan
