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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

Primary Purpose

Hemodynamic Stability

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine 0.5% Injectable Solution
Prilocaine Hydrochloride 2% Injection
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemodynamic Stability

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: refusal Allergy to the studied drugs. Patients with contraindications to spinal anesthesia. Patients with advanced decompensated cardiac, renal, hepatic disease Coagulopathy or thrombocytopenia

Sites / Locations

  • Assuit universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group M

Group p

Arm Description

Outcomes

Primary Outcome Measures

Monitoring blood pressure both systole and diastole
When, how the chang in the baseline

Secondary Outcome Measures

Full Information

First Posted
February 23, 2023
Last Updated
May 17, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05877690
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Spinal anesthesia has become increasingly popular for inpatient surgery, but, until recently, its use has been limited in ambulatory surgery due to the lack of a safe and licensed short-acting local anesthetic agent. An ideal intrathecal agent for ambulatory surgery should have a rapid onset of motor and sensory blockade, predictable regression within an acceptable time frame, and a low incidence of adverse effects. Hyperbaric Bupivacaine is a long-acting local anesthetic from the amide group and has a low incidence of transient neurological symptoms (TNS). Because of its pharmacological profile, the recovery of motor and sensory blocks is delayed compared to short-acting local anesthetics. The incidence of postoperative urinary retention with long-acting local anesthetics like bupivacaine is higher than with short-acting local anesthetics . Successful spinal anesthesia with low doses of bupivacaine between 5 and 10 mg without additives has been described for outpatients. The incidence of urinary retention was still 3.7-16%. Furthermore, with these low doses, block height becomes unpredictable, and the risk of block failure is high . Prilocaine is an amide local anesthetic with an intermediate duration of action after spinal administration. Recently, the old local anesthetics prilocaine was reintroduced in the market. It is available in the hyperbaric form and provides anesthesia for 75-90 min after spinal administration . Hyperbaric prilocaine 2% is increasingly used for spinal anesthesia in the ambulatory setting , as it has the advantage of faster recovery times than hyperbaric bupivacaine . We aimed to compare spinal anesthesia using hyperbaric prilocaine 2% and hyperbaric bupivacaine 0.5% for day case surgery in terms of sensory block, and motor block resolution times. The time for first spontaneous voiding and duration of stay in the PACU and time to home readiness. Vascular disease and cardiac dysfunction are linked in many ways. They share common risk factors and comorbidities, and patients with systemic vascular disease often have concomitant heart disease, because the blood vessels of the heart are not spared. In patients presenting for surgery, the presence of vascular disease puts the patient at increased risk for perioperative cardiac complications, and vascular surgery poses the highest surgical risk for perioperative cardiac events. In addition, the diseased vessels supplying critical organs depend on the perfusion pressure supplied by the heart, so any cardiac dysfunction thus amplifies the effect of poor perfusion. Patients presenting with both vascular disease and cardiac dysfunction pose a particular challenge to the anesthesiologist; although treatment goals are similar small physiologic disturbances can quickly lead to large, serious changes in clinical status. Selective spinal anesthesia performed with a short-term hyperbaric local anesthetic could be a perfect solution, because it guarantees rapid sensory and motor block, predictable duration, and low incidence of side effects. It is usually well accepted by both patients and surgeons due to its high reliability, as it provides effective analgesia, with minimal side effects, rapid changeover times, and low costs .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamic Stability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group M
Arm Type
Experimental
Arm Title
Group p
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5% Injectable Solution
Other Intervention Name(s)
Marcaine
Intervention Description
Patient will be received the drug intrathecal
Intervention Type
Drug
Intervention Name(s)
Prilocaine Hydrochloride 2% Injection
Other Intervention Name(s)
Takipril
Intervention Description
Patient will be received the drug intrathecal
Primary Outcome Measure Information:
Title
Monitoring blood pressure both systole and diastole
Description
When, how the chang in the baseline
Time Frame
75 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: refusal Allergy to the studied drugs. Patients with contraindications to spinal anesthesia. Patients with advanced decompensated cardiac, renal, hepatic disease Coagulopathy or thrombocytopenia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zahwa Yehya, Master
Phone
+0201007968687
Email
drzahwa1996@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Saeid Metwally
Phone
+0201030072161
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekram Abdullah, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Assuit university
City
Assiut
State/Province
Assuit
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assuit university
Phone
+209922080150
Email
Vp_grad@aun.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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