NCT06165679

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

December 2, 2023

Last Update Submit

June 30, 2025

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

  • Hypotension

    Incidence of hypotension from local anesthetic injection

    Till 30 minutes after spinal anesthesia.

Secondary Outcomes (1)

  • Use of vasopressor drugs

    Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia

Other Outcomes (2)

  • Mean and systolic arterial blood pressure values

    Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia

  • Heart rate

    Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia

Study Arms (2)

Prilocaine group

ACTIVE COMPARATOR
Drug: Prilocaine

Bupivacaine GROUP

ACTIVE COMPARATOR
Drug: Bupivacaine

Interventions

PrilocaineDRUG

The patients will receive a single injection of spinal anesthesia using prilocaine plus fentanyl

Prilocaine group
BupivacaineDRUG

The patients will receive a single injection of spinal anesthesia using Bupivacaine plus fentanyl

Bupivacaine GROUP

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alaini hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

PrilocaineBupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anaesthesia

Study Record Dates

First Submitted

December 2, 2023

First Posted

December 11, 2023

Study Start

December 20, 2023

Primary Completion

June 1, 2025

Study Completion

June 30, 2025

Last Updated

July 2, 2025

Record last verified: 2025-06

Locations

EG(1)