search
Back to results

Effect of Stellate Ganglion Block on Internal Mammary Artery Dynamics

Primary Purpose

Anesthesia

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Left stellate ganglion block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18 to 65 years. Patients who will be slated to undergo elective coronary artery bypass graft surgery under Cardiopulmonary bypass in the Department of Cardiothoracic Surgery. Exclusion Criteria: Patient not willing to participate in the study. Age more than 65 years. Ejection fraction < 45%. History of strokes / Transient ischaemic attacks and vertebro basilar insufficiency History of Glaucoma. History of allergy to local anaesthetic drugs. Emergency coronary artery bypass graft or reoperations. Pre-existing contralateral phrenic nerve palsy. Patients with existing coagulopathy.

Sites / Locations

  • Ain shams university hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

The first group (A)(Left internal mammary artery diameter before left stellate ganglion block ).

The second Group (B)(Left internal mammary artery diameter after left stellate ganglion block )

Arm Description

control group

same group but after intervention

Outcomes

Primary Outcome Measures

Change of Left internal mammary artery internal diameter
diameter will be measured before, 10 min, and 20 min after the block at the level of 2nd, 3rd, 4th and 5th rib by the ultrasound.

Secondary Outcome Measures

Systolic blood pressure (SBP)
Effect of the block on hemodynamics
diastolic blood pressure (DBP)
Effect of the block on hemodynamics
mean blood pressure (MBP)
Effect of the block on hemodynamics
heart rate (HR))
Effect of the block on hemodynamics

Full Information

First Posted
July 11, 2023
Last Updated
August 8, 2023
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT05952011
Brief Title
Effect of Stellate Ganglion Block on Internal Mammary Artery Dynamics
Official Title
Effect of Stellate Ganglion Block on Internal Mammary Artery Dynamics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams 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
The aim of this study is to compare the diameter of Left internal mammary artery and its blood flow by using the pulsatility index before and after the left stellate ganglion block in patients undergoing coronary artery bypass grafting.
Detailed Description
The internal mammary artery (IMA) is the preferred graft for myocardial revascularization because of its superiority over venous grafts owing to long term patency, lower mortality rates and improved post-operative outcomes. However, conduit spasm is a recognized complication of coronary artery bypass surgery mainly affecting the arterial conduits, a major concern that can lead to acute myocardial ischemia and may contribute to reduce graft patency. Topical application or systemic administration of many pharmacological agents has been shown to reverse or prevent graft spasm, but side effects are reported with the use of these agents. Various vasodilators that have been tried included various organic nitrates, calcium channel blockers, sodium nitroprusside (SNP) and papaverine. Over the last few years, there were some studies, which investigated the effect of regional anesthesia techniques such as thoracic epidural anesthesia (TEA) and stellate ganglion block (SGB) for sympatholysis and studied its effects on internal mammary artery diameter . The stellate ganglion block with local anesthetics have been widely used to provide pain relief to treat vascular spastic disorders of upper limbs, chronic pain conditions and treatment of refractory angina. The stellate ganglion block has also been used for increasing radial artery (RA) blood flow and preventing RA spasm by sympathetic blockade in coronary artery bypass surgery. In our study, two groups will be compared regarding the internal mammary artery diameter and its blood flow using the pulsatility index before and after stellate ganglion block.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The first group (A)(Left internal mammary artery diameter before left stellate ganglion block ).
Arm Type
Active Comparator
Arm Description
control group
Arm Title
The second Group (B)(Left internal mammary artery diameter after left stellate ganglion block )
Arm Type
Active Comparator
Arm Description
same group but after intervention
Intervention Type
Procedure
Intervention Name(s)
Left stellate ganglion block
Intervention Description
patients will be positioned with head in midline position and mild extension of the neck. Cricoid cartilage will be identified by midline palpation of the neck and a 12 mega hertz ultrasound probe will be used. The airway will be identified by the shadow of the cricoid cartilage at the level of C6 vertebrae. The probe will be moved laterally to identify internal jugular vein, carotid artery and thyroid. Depth of ultrasound field will be adjusted to include the transverse process of the C6 vertebra. Following complete aseptic precautions, an echogenic insulated needle 5 cm long will be inserted under ultrasound guidance and directed toward the transverse process of the C6 vertebra. After the needle tip will make contact with the transverse process, it will be withdrawn 2 mm and 8 ml of 0.25% bupivacaine will be injected.
Primary Outcome Measure Information:
Title
Change of Left internal mammary artery internal diameter
Description
diameter will be measured before, 10 min, and 20 min after the block at the level of 2nd, 3rd, 4th and 5th rib by the ultrasound.
Time Frame
(diameter after block - diameter before the block) at 10 min, and 20 min after block.
Secondary Outcome Measure Information:
Title
Systolic blood pressure (SBP)
Description
Effect of the block on hemodynamics
Time Frame
Baseline, every 5 minutes after the block for 20 minutes, immediately before measuring internal mammary artery blood flow, at 10 minutes post aortic cross clamp, during rewarming, and at every 10-minute till ICU transferal up to 1 day
Title
diastolic blood pressure (DBP)
Description
Effect of the block on hemodynamics
Time Frame
Baseline, every 5 minutes after the block for 20 minutes, immediately before measuring internal mammary artery blood flow, at 10 minutes post aortic cross clamp, during rewarming, and at every 10-minute till ICU transferal up to 1 day
Title
mean blood pressure (MBP)
Description
Effect of the block on hemodynamics
Time Frame
Baseline, every 5 minutes after the block for 20 minutes, immediately before measuring internal mammary artery blood flow, at 10 minutes post aortic cross clamp, during rewarming, and at every 10-minute till ICU transferal up to 1 day
Title
heart rate (HR))
Description
Effect of the block on hemodynamics
Time Frame
Baseline, every 5 minutes after the block for 20 minutes, immediately before measuring internal mammary artery blood flow, at 10 minutes post aortic cross clamp, during rewarming, and at every 10-minute till ICU transferal up to 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18 to 65 years. Patients who will be slated to undergo elective coronary artery bypass graft surgery under Cardiopulmonary bypass in the Department of Cardiothoracic Surgery. Exclusion Criteria: Patient not willing to participate in the study. Age more than 65 years. Ejection fraction < 45%. History of strokes / Transient ischaemic attacks and vertebro basilar insufficiency History of Glaucoma. History of allergy to local anaesthetic drugs. Emergency coronary artery bypass graft or reoperations. Pre-existing contralateral phrenic nerve palsy. Patients with existing coagulopathy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diaaeldin DA Aboelnile, MD, Lecturer
Phone
201018380033
Email
diaabadr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amira AH Hawas, Ass.Lecturer
Phone
201006217802
Email
amirayousry508@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diaaeldin DA Aboelnile, MD, Lecturer
Organizational Affiliation
Faculty of Medicine, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain shams university hospitals
City
Cairo
ZIP/Postal Code
11588
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diaaeldin BM Aboelnile, MD
Phone
2001018380033
Email
diaabadr@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Stellate Ganglion Block on Internal Mammary Artery Dynamics

We'll reach out to this number within 24 hrs