Sedation and Analgesia Using PFK Versus General Anesthesia in Urological Procedures

NCT04285528 | Completed

• 1 other identifier: 67/2019/1166
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Urologic Diseases

Keywords

General anesthesia; Sedation; Propofol; Fentanyl; Ketamine; Hypotension

Outcome Measures

Primary Outcomes (1)

• Blood pressure stability

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

  45 minutes

Secondary Outcomes (2)

• Hypoxia

  45 minutes

• nausea and vomiting

  2 hours

Study Arms (2)

General Anesthesia

EXPERIMENTAL

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

PFK group

EXPERIMENTAL

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

Interventions

General anesthetia Fentanyl and Propofol DRUG

Patients were anesthetized using Fentanyl (2 mcg per kg) and Propofol (1-2 mg per kg). Proper classic laryngeal mask airway was inserted afterwards.

Also known as: GA

General Anesthesia

PFK COMBINATION_PRODUCT

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.

Also known as: propofol-ketamine-fentanyl (PFK) mixture, the mixture of propofol, ketamine, fentanyl, with lidocaine

PFK group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, 13046, Jordan

Location

Related Publications (21)

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MeSH Terms

Conditions

Urologic Diseases; Hypotension

Interventions

Propofol; Ketamine; Fentanyl

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 26, 2020
• Study Start: April 17, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)