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

Hemodynamic Instability Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06165679
• Other study ID #: N-439-2023
• Status: Recruiting
• Phase: Phase 3
• Start date: December 20, 2023
• Est. completion date: July 15, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: July 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Drug:
• Prilocaine
The patients will receive a single injection of spinal anesthesia using prilocaine plus fentanyl
• Bupivacaine
The patients will receive a single injection of spinal anesthesia using Bupivacaine plus fentanyl

Locations

Country	Name	City	State
Egypt	Kasr Alaini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean and systolic arterial blood pressure values	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
Other	Heart rate	Heart rate after spinal anesthesia	Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia
Primary	Hypotension	Incidence of hypotension from local anesthetic injection	Till 30 minutes after spinal anesthesia.
Secondary	Use of vasopressor drugs	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