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A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.

NCT05726968 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-10-16

No results posted yet for this study

Summary

To compare the effects of using different doses of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg in patients scheduled for a day-case lower abdominal and urologic surgery in the geriatric patient population.

Conditions

  • Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl

Interventions

DRUG

Pilocaine 2% (1.5 ml) and 25 ug fentany

Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows: * Group P1 (N 15): patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml). * Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). * Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).

Sponsors & Collaborators

  • Norhan Abdel Aleem Ali

    collaborator UNKNOWN

  • Hagar Hassanein Refaee

    collaborator UNKNOWN

  • Ahmed Abdullah Fathi Mohamed Almadawi

    collaborator UNKNOWN

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2023-06-16
Completion
2023-12-05

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726968 on ClinicalTrials.gov