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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04285528
Enrollment
200
Registered
2020-02-26
Start date
2019-04-17
Completion date
2020-02-01
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Urologic Diseases

Keywords

General anesthesia, Sedation, Propofol, Fentanyl, Ketamine, Hypotension

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.

Interventions

DRUGGeneral 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_PRODUCTPFK

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.

Sponsors

University of Jordan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure stability45 minutesthe investigators recorded the changes in blood pressure after induction of anesthesia

Secondary

MeasureTime frameDescription
Hypoxia45 minutesthe investigators recorded any episodes of transient reduction of oxygen saturation.
nausea and vomiting2 hoursThe investigators recorded the occurrence of nausea and vomiting till the discharge of the patients from post anesthesia care unit (PACU).

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026