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Sedation and Analgesia Using PFK Versus General Anesthesia in Urological Procedures

Primary Purpose

Anesthesia, Urologic Diseases

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
General anesthetia Fentanyl and Propofol
PFK
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring General anesthesia, Sedation, Propofol, Fentanyl, Ketamine, Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Jordan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

General Anesthesia

PFK group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood pressure stability
the investigators recorded the changes in blood pressure after induction of anesthesia

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2020
Last Updated
February 29, 2020
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT04285528
Brief Title
Sedation and Analgesia Using PFK Versus General Anesthesia in Urological Procedures
Official Title
Intravenous Sedation and Analgesia Using Propofol, Fentanyl and Ketamine (PFK) Versus General Anesthesia in Minor Urological Procedures.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Urologic Diseases
Keywords
General anesthesia, Sedation, Propofol, Fentanyl, Ketamine, Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General Anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
PFK group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
General anesthetia Fentanyl and Propofol
Other Intervention Name(s)
GA
Intervention Description
Patients were anesthetized using Fentanyl (2 mcg per kg) and Propofol (1-2 mg per kg). Proper classic laryngeal mask airway was inserted afterwards.
Intervention Type
Combination Product
Intervention Name(s)
PFK
Other Intervention Name(s)
propofol-ketamine-fentanyl (PFK) mixture, the mixture of propofol, ketamine, fentanyl, with lidocaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure stability
Description
the investigators recorded the changes in blood pressure after induction of anesthesia
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Hypoxia
Description
the investigators recorded any episodes of transient reduction of oxygen saturation.
Time Frame
45 minutes
Title
nausea and vomiting
Description
The investigators recorded the occurrence of nausea and vomiting till the discharge of the patients from post anesthesia care unit (PACU).
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Jordan University Hospital
City
Amman
ZIP/Postal Code
13046
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No
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Sedation and Analgesia Using PFK Versus General Anesthesia in Urological Procedures

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