Sedation and Analgesia Using PFK Versus General Anesthesia in Urological Procedures

Not Applicable

Completed

• Conditions: Anesthesia; Urologic Diseases
• Interventions: Drug: General anesthetia Fentanyl and Propofol; Combination Product: PFK

• Registration Number: NCT04285528
• Lead Sponsor: University of Jordan

Brief 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.

Study Timeline

• Study Start: 2019-04-17
• Primary Completion: 2019-12-01
• Status Verified: 2020-02
• Study Completion: 2020-02-01
• Study First Submitted: 2020-02-23
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-26
• Last Update Submitted: 2020-02-29
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• patients above the age of 30 years
• patients who were admitted for minor urological surgeries under the care of urology team. Minor urological procedures, included cystoscopy, trans-urethral resection of tumor (TURT), uretroscopy, double J insertion, and double J removal.

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anesthesia	General anesthetia Fentanyl and Propofol	The first group which will undergo general anesthesia, will be anesthetized using Fentanyl (2 mcg per kg) and Propofol (1-2 mg per kg). Laryngeal mask airway will be inserted afterwards.
PFK group	PFK	The second group will undergo 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 will be added, this aims to reduce the pain on injection caused by Propofol. Moreover, 4 ml of water for injection will be added to the mixture.

Primary Outcome Measures

Name	Time	Method
Blood pressure stability	45 minutes	the investigators recorded the changes in blood pressure after induction of anesthesia

Secondary Outcome Measures

Name	Time	Method
Hypoxia	45 minutes	the investigators recorded any episodes of transient reduction of oxygen saturation.
nausea and vomiting	2 hours	The investigators recorded the occurrence of nausea and vomiting till the discharge of the patients from post anesthesia care unit (PACU).

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Jordan