NCT04285528

Sedation and Analgesia Using PFK Versus General Anesthesia in Urological Procedures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Jordan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The first group which underwent general anesthesia, was anesthetized using Fentanyl (2 mcg per kg) and Propofol (1-2 mg per kg). Laryngeal mask airway was then inserted. The second group underwent intravenous sedation and analgesia by using a mixture of Fentanyl, Propofol and Ketamine (PFK mixture). The mixture consists of 100 mcg Fentanyl, 100 mg Propofol, 100 mg of Ketamine. In addition, 40 mg of Lidocaine were added, this aimed to reduce the pain on injection caused by Propofol. Moreover, 4 ml of water of injection were added to the mixture. This resulted in a mixture of 5 mcg/ml of Fentanyl, 5 mg/ml of Propofol, and 5 mg/ml of Ketamine. By this, each ml of the mixture contained 10 mg (ketamine and propofol) + 5 mcg fentanyl. 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 support of 3 L/min O2.

Conditions

• Anesthesia
• Urologic Diseases

Interventions

Type	Name	Description
DRUG	General anesthetia Fentanyl and Propofol	Patients were anesthetized using Fentanyl (2 mcg per kg) and Propofol (1-2 mg per kg). Proper classic laryngeal mask airway was inserted afterwards.
COMBINATION_PRODUCT	PFK	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.

Timeline

• Start date: 2019-04-17
• Primary completion: 2019-12-01
• Completion: 2020-02-01
• First posted: 2020-02-26
• Last updated: 2020-03-03

Locations

1 site across 1 country: Jordan