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

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.

Intervention / Treatment

  • PK general anesthesia (DRUG)
    Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).
  • PFK combination (DRUG)
    Each patient received an initial dose of 0.05 ml/kg from the solution, then after waiting for 60 seconds, another 0.05 ml/kg were given. Maintenance was given as boluses of 0.025 ml/kg every three to five minutes.

Condition or Disease

  • Anesthesia


  • Not Applicable
  • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 200 (ESTIMATED)
    Funded by: Other
    Allocation: Non-Randomized
    Primary Purpose: Prevention


    Clinical Trial Dates

    Start date: Aug 01, 2020 ESTIMATED
    Primary Completion: Dec 01, 2020 ESTIMATED
    Completion Date: Jun 01, 2021 ESTIMATED
    Study First Posted: Jul 16, 2020 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 13, 2020

    Sponsors / Collaborators

    Lead Sponsor: University of Jordan
    Responsible Party: N/A


    Participant Groups

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

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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).

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

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

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

    More Details

    NCT Number: NCT04473846
    Other IDs: 67/2020/524
    Study URL:
    Last updated: Sep 29, 2023