Effect of Stellate Ganglion Block on Internal Mammary Artery Dynamics

NCT05952011 | Completed

• 1 other identifier: FMASU MD124/2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the effect of a stellate ganglion block on the flow and diameter of the internal mammary artery using the pulsatility index and transient time flowmetry(TTFM) in patients undergoing coronary artery bypass grafting.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Effect of left stellate ganglion block on the left internal mammary artery blood flow after 10 minutes

  LIMA blood flow will be measured using the pulsatility index

  10 minutes after the left Stellate Ganglion Block

Secondary Outcomes (4)

• Change in Left Internal Mammary Artery (LIMA) diameter after left Stellate Ganglion Block

  10 minutes after block

• Effect of left stellate ganglion block on the left internal mammary artery blood flow after cardiopulmonary bypass

  After cardiopulmonary bypass

• Effect of left stellate ganglion block on mean blood pressure (MBP)

  During surgery: baseline, after induction of anesthesia, at time after skin incision, after sternotomy, before and after cardiopulmonary bypass (CPB), after protamine and at the end of operation

• Effect of left stellate ganglion block on heart rate (HR))

  During surgery: baseline, after induction of anesthesia, at time after skin incision, after sternotomy, before and after cardiopulmonary bypass (CPB), after protamine and at the end of operation

Study Arms (2)

The first group (A) Stellate Ganglion Block Group

EXPERIMENTAL

Participants in this group will receive a left stellate ganglion block (LSGB) preoperatively. The IMA pulsatility index and diameter will be measured before and after the stellate ganglion block and during both the preoperative and the intraoperative periods. Transit-time flowmetry (TTFM) will be used intraoperatively to assess IMA flow.

Procedure: Left stellate ganglion block; Drug: Topical Nitroglycerine

The second Group (B) Control Group (No left stellate ganglion block LSGB)

ACTIVE COMPARATOR

Participants in this group will not receive a stellate ganglion block. The IMA pulsatility index and diameter will be measured before and after the stellate ganglion block and during both the preoperative and the intraoperative periods. Transit-time flowmetry (TTFM) will be used intraoperatively to assess IMA flow. Topical nitroglycerin will also be applied intraoperatively, similar to the SGB group.

Drug: Topical Nitroglycerine

Interventions

Left stellate ganglion block PROCEDURE

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.

The first group (A) Stellate Ganglion Block Group

Topical Nitroglycerine DRUG

Application of topical Nitroglycerin solution to the LIMA pedicle graft during dissection of the vessel in both study arms.

The first group (A) Stellate Ganglion Block Group; The second Group (B) Control Group (No left stellate ganglion block LSGB)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Allergy to nitroglycerin.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospitals

Cairo, 11588, Egypt

Location

MeSH Terms

Interventions

Nitroglycerin

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Diaaeldin DA Aboelnile, MD, Lecturer

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: August 8, 2023
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)