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

NCT04473846 | Unknown

• 1 other identifier: 67/2020/524
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Anesthesia; Endoscopy; Colonoscopy

Outcome Measures

Primary Outcomes (3)

• Transient decrease in oxygen saturation

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

  1 hour

• Blood pressure stability

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

  1 hour

• Recovery time

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

  2 hours

Study Arms (2)

PF group

EXPERIMENTAL

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

Drug: PK general anesthesia

PFK group

EXPERIMENTAL

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

Interventions

PK general anesthesia DRUG

Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).

PF group

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.

PFK group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, 13046, Jordan

Location

Central Study Contacts

Abdelkarim S AlOweidi

CONTACT

+962795712121; akaloweidi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

JO (1)