Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures.

Not Applicable

• Conditions: Anesthesia
• Interventions: Drug: PFK combination; Drug: PK general anesthesia

• Registration Number: NCT04473846
• Lead Sponsor: University of Jordan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-13
• Study First Posted: 2020-07-16
• Last Update Posted: 2020-07-16
• Study Start: 2020-08
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PFK group	PFK combination	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.
PF group	PK general anesthesia	The first group will undergo general anesthesia using Fentanyl and Propofol.

Primary Outcome Measures

Name	Time	Method
Recovery time	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	1 hour	the investigators will record any episodes of transient reduction of oxygen saturation.
Blood pressure stability	1 hour	the investigators will record changes in blood pressure after induction of anesthesia

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Jordan