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

Sponsor

University of Jordan (Other)

Overall Status

Unknown status

CT.gov ID

NCT04473846

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: PK general anesthesia Drug: PFK combination	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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
Recovery time [2 hours]
the investigators will document recovery time in the post anesthesia care unit (PACU) until recovery of full consciousness.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jordan University Hospital	Amman		Jordan	13046

Sponsors and Collaborators

University of Jordan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdelkarim Saleh AlOweidi, Principal Investigator, University of Jordan

ClinicalTrials.gov Identifier:

NCT04473846

Other Study ID Numbers:

67/2020/524

First Posted:

Jul 16, 2020

Last Update Posted:

Jul 16, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Abdelkarim Saleh AlOweidi, Principal Investigator, University of Jordan

Anesthesia

Endoscopy

Colonoscopy

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Jul 16, 2020