Selective Spinal Anaesthesia With Hyperbaric Prilocain With 2%Provides Better Perioperative Hemodynamic Stability for Patients With Peripheral Vascular Disease and Cardiac Dysfunction in Lower Limb Surgery
Selective Spinal Anesthesia Using Hyperbaric Prilocaine 2% Provides Better Perioperative Hemodynamic Stability for Patients With Peripheral Vascular Disease and Cardiac Dysfunction Undergoing Lower Limb Vascular Surgery
1 other identifier
interventional
80
1 country
1
Brief Summary
to compare the safety and efficacy of spinal anesthesia using Hyperbaric Prilocaine 2% versus Hyperbaric Bupivacaine 0.5% for patients with peripheral vascular disease and cardiac dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2023
CompletedFirst Posted
Study publicly available on registry
May 26, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMay 26, 2023
March 1, 2023
1 year
February 23, 2023
May 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Monitoring blood pressure both systole and diastole
When, how the chang in the baseline
75 minutes
Study Arms (2)
Group M
EXPERIMENTALGroup p
EXPERIMENTALInterventions
Patient will be received the drug intrathecal
Patient will be received the drug intrathecal
Eligibility Criteria
You may qualify if:
- Adult patients of aged \>18 years old. Both sexes, males and females.
- The time of surgery does not exceed 75 min.
- Compensated cardiac dysfunction
- ASA physical status: II- IV
You may not qualify if:
- refusal
- Allergy to the studied drugs.
- Patients with contraindications to spinal anesthesia.
- Patients with advanced decompensated cardiac, renal, hepatic disease
- Coagulopathy or thrombocytopenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assuit university
Asyut, Assuit, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ekram Abdullah, Professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 23, 2023
First Posted
May 26, 2023
Study Start
October 1, 2023
Primary Completion
October 1, 2024
Study Completion
December 1, 2024
Last Updated
May 26, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share