Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients

June 30, 2025 updated by: AbdElKhalik Mahmoud Shaban, Cairo University

Comparison Between the Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients Undergoing Endoscopic Urological Surgeries: A Randomized Controlled Trial

Data comparing prilocaine vs bupivacaine in equipotent doses in the elderly are lacking; therefore, the study will compare the effect of prilocaine vs bupivacaine on hemodynamics in spinal anesthesia for geriatric patients undergoing endoscopic urological surgeries

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 3

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

  • Egypt
      • Cairo, Egypt
        • Kasr Alaini 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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 65 years old and above.
  • Both genders.
  • Patients scheduled to undergo endoscopic urological surgeries.
  • ASA I and II class.

Exclusion Criteria:

  • Patient refusal.
  • Known local anesthetic (LA) allergy.
  • Bleeding disorders.
  • Skin lesions or infections at site of needle insertion.
  • Hypertensive patients.
  • Patients candidate for transurethral resection of the prostate
  • ASA III and VI class

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prilocaine group
Drug: Prilocaine
The patients will receive a single injection of spinal anesthesia using prilocaine plus fentanyl
Active Comparator: Bupivacaine GROUP
Drug: Bupivacaine
The patients will receive a single injection of spinal anesthesia using Bupivacaine plus fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypotension
Time Frame: Till 30 minutes after spinal anesthesia.
Incidence of hypotension from local anesthetic injection
Till 30 minutes after spinal anesthesia.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of vasopressor drugs
Time Frame: Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia
Total doses of vasopressor drugs used for hypotension treatment
Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean and systolic arterial blood pressure values
Time Frame: Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia
Mean and systolic arterial blood pressure values after spinal anesthesia
Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia
Heart rate
Time Frame: Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia
Heart rate after spinal anesthesia
Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia

Collaborators and Investigators

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

Sponsor

Cairo University

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)

December 20, 2023

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-439-2023

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.

No

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.

Clinical Trials on Hemodynamic Instability

Clinical Trials on Prilocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe