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

University of Jordan

Status: Unknown

Conditions: Anesthesia

Treatments: Drug: PK general anesthesia; Drug: PFK combination

Study type: Interventional

Funder types: Other

Identifiers

NCT04473846

67/2020/524

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

PF group

Experimental group

Description:

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

Treatment:

Drug: PK general anesthesia

PFK group

Experimental group

Description:

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.

Treatment:

Drug: PFK combination