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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04473846
• Other study ID #: 67/2020/524
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: June 2021

Study information

• Verified date: July 2020
• Source: University of Jordan
• Contact: Abdelkarim S AlOweidi
• Phone: +962795712121
• Email: akaloweidi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• PK general anesthesia
Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).
• 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.

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

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