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NCT Number: NCT06165679

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

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

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Key information

Conditions

Hemodynamic Instability

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Alaini hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prilocaine

Drug

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

Bupivacaine

Drug

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

Primary outcomes

  1. Hypotension

    Time frame: Till 30 minutes after spinal anesthesia.

    Incidence of hypotension from local anesthetic injection

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2023
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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