Sedation and Analgesia Using PFK Versus General Anesthesia in Urological Procedures

February 29, 2020 updated by: Abdelkarim Saleh AlOweidi, University of Jordan

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 13046
        • Jordan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: General Anesthesia
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.
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.
Other Names:
  • GA
EXPERIMENTAL: PFK group
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.
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.
Other Names:
  • propofol-ketamine-fentanyl (PFK) mixture
  • the mixture of propofol, ketamine, fentanyl, with lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure stability
Time Frame: 45 minutes
the investigators recorded the changes in blood pressure after induction of anesthesia
45 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 17, 2019

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

February 23, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (ACTUAL)

February 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2020

Last Update Submitted That Met QC Criteria

February 29, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67/2019/1166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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