CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
General anesthetia Fentanyl and Propofol +1 moredrug
Likely dose
General anesthetia Fentanyl and Propofol 2 mcgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04285528
NCT04285528N/ACompleted

Intravenous Sedation and Analgesia Using Propofol, Fentanyl and Ketamine (PFK) Versus General Anesthesia in Minor Urological Procedures.

University of Jordan·interventional·Posted Feb 26, 2020·Updated Mar 3, 2020

In Brief

A clinical study evaluating General anesthetia Fentanyl and Propofol and PFK for Anesthesia and Urologic Diseases. Completed, enrolled 200 participants across 1 site.

Detailed Summary

Anesthesia in urological surgeries might constitute a great challenge to anesthesiologists. Especially that a great proportion of these patients are elderly with a lot of comorbidities. This put these patients at the risk of developing medical adverse events after being anesthetized by general anesthesia. The aim of this study is to compare between intravenous sedation with analgesia versus general anesthesia in patients undergoing urological surgical procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJordan
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 26, 2020
Enrollment StartApr 17, 2019
Primary CompletionDec 1, 2019
Study CompletionFeb 1, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.4 years ago

Interventions

General anesthetia Fentanyl and Propofoldrug

Patients were anesthetized using Fentanyl (2 mcg per kg) and Propofol (1-2 mg per kg). Proper classic laryngeal mask airway was inserted afterwards.

PFKcombination

A mixture of 5 mcg/ml of Fentanyl, 5 mg/ml of Propofol, and 5 mg/ml of Ketamine was used. Each patient received an initial dose of 0.5 mg/kg from the solution, then after waiting for 60 seconds, another 0.5 mg/kg were given. Maintenance was given as boluses of 0.2- 0.33 mg/kg every three to five minutes. No Laryngeal mask airway nor endotracheal tube were inserted, and the patients were breathing spontaneously through a simple face mask on a support of 3 L/min O2.