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

NCT ID: NCT04473846

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2021-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PF group

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

Group Type: EXPERIMENTAL

PK general anesthesia

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

PFK combination

Intervention Type: 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.

Interventions

PK general anesthesia

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Abdelkarim Saleh AlOweidi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jordan University Hospital

Amman, , Jordan

Countries

Jordan

Central Contacts

Abdelkarim S AlOweidi

Role: CONTACT

akaloweidi@hotmail.com

+962795712121

Facility Contacts

Shawqi Saleh

Role: primary

sssaleh@hotmail.com

+962795577922

Noor Rammadan

Role: backup

nm_rammadan@yahoo.com

+962796234137

Other Identifiers

67/2020/524

Identifier Type: -

Identifier Source: org_study_id