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Trial Title:
Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery
NCT ID:
NCT06300658
Condition:
Stellate Ganglion Block
Arteriovenous Fistula
Hemodialysis
Major Lower Limb Orthopedic Surgery
Conditions: Official terms:
Ganglion Cysts
Synovial Cyst
Arteriovenous Fistula
Fistula
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Stellate ganglion block
Description:
Patient will receive preemptive stellate ganglion block (SGB) just before spinal
anesthesia.
Arm group label:
Stellate ganglion blockade
Summary:
The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for
preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb
orthopedic surgery.
Detailed description:
The best way for dialysis in chronic renal failure (CRF) patients with consideration of
feasibility, rate of infection, and patency is hemodialysis by using native access by
using arteriovenous fistula (AVF).
Altered calcium and phosphor metabolism in CRF patients would also increase vascular
reactivity. Stellate ganglion blockade (SGB) has been used for several years for both
diagnosis and treatment of circulatory problems in upper extremity. Recently preemptive
SGB has been used in prevention of radial artery spasm in coronary artery patients.
SGB increases blood flow and decrease vascular resistance in the arm. SGB prevents or
ameliorates the reactivity of the muscular layer of the RA in response to both surgical
manipulation during harvesting the artery and to the potent vasoconstrictor mediators
released during surgery
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 21 to 75 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status III.
- Chronic renal failure (CRF) patients.
- Undergoing major lower limb orthopedic surgery.
Exclusion Criteria:
- Psychiatric disorders.
- History of substance abuse.
- Ipsilateral brachial and radial artery stenosis.
- Allergy to local anesthetics.
- Cardiovascular and respiratory disorders.
- Coagulopathy.
- Use of vasoactive medications.
- Obesity (body mass index >30 kg/m2).
- Smoking.
Gender:
All
Minimum age:
21 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Aswan University
Address:
City:
Aswan
Zip:
81528
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Ayman M Eldemrdash, MD
Phone:
00201001296116
Email:
ayman.mohamady@aswu.edu.eg
Investigator:
Last name:
Soudy S Hammad, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tarek S Hemaida, MD
Email:
Sub-Investigator
Investigator:
Last name:
Taha T Dardeer, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ahmed A Mohsen, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ahmed K Fathy, MD
Email:
Sub-Investigator
Investigator:
Last name:
Gamal H Shams, MD
Email:
Sub-Investigator
Start date:
March 9, 2024
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Aswan University
Agency class:
Other
Source:
Aswan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06300658
