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

July 13, 2020 updated by: Abdelkarim Saleh AlOweidi, University of Jordan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PF group
The first group will undergo general anesthesia using Fentanyl and Propofol.
Drug: PK general anesthesia
Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).
EXPERIMENTAL: 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.
Drug: PFK combination
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transient decrease in oxygen saturation
Time Frame: 1 hour
the investigators will record any episodes of transient reduction of oxygen saturation.
1 hour
Blood pressure stability
Time Frame: 1 hour
the investigators will record changes in blood pressure after induction of anesthesia
1 hour
Recovery time
Time Frame: 2 hours
the investigators will document recovery time in the post anesthesia care unit (PACU) until recovery of full consciousness.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (ACTUAL)

July 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67/2020/524

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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