Stellate Ganglion Block in Beating Heart Surgery

NCT03450226 | Unknown

• 1 other identifier: SGB in beating heart surgery
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

studies suggest that off-pump coronary artery bypass surgery is associated with improved outcomes when compared to on-pump coronary artery bypass. many studies have shown that off-pump coronary bypass surgery reduces patient morbidity and mortality. manipulation of the coronary arteries during cardiac surgery can stimulate the adjacent post-ganglionic sympathetic fibers and mimic stellate ganglion stimulation ,stellate ganglion block (SGB) can interrupt this reflex by decreasing the efferent cervical sympathetic outflows.

Conditions

Cardiac Arrythmias

Outcome Measures

Primary Outcomes (1)

• postoperative electrocardiogram changes

  absence of new onset postoperative cardiac arrhythmia and myocardial infarction after off-pump coronary artery bypass surgery

  up to 7 days

Study Arms (2)

treatment

EXPERIMENTAL

patients will receive a stellate ganglion block with 10 ml of 0.25 % bupivacaine

Drug: stellate ganglion block

control

NO INTERVENTION

patients will be controlled

Interventions

stellate ganglion block DRUG

After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 or C7. After advancing to the transverse process the needle will be withdrawn 2-3 mm prior to injection. A negative aspiration test will be performed in two planes before a 1-ml test dose is used to exclude unintentional intravascular injection (vertebral or subclavian arteries) or subarachnoid injection into the dural sleeve.4 A total of 10 ml of 0.25% bupivacaine will be injected.

Also known as: bupivacaine, marcaine

treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients undergoing elective off-pump coronary artery bypass grafting surgery
• patients with an ejection fraction of more than 50%
• creatinine level of less than 2.0 mg / 100 ml
• no evidence of heart failure
• no significant chronic obstructive lung disease
• age of less than 60 years

You may not qualify if:

• emergency surgery
• patients on thrombolytic therapy
• patients with coagulation disorders
• patients requiring heart lung machine
• patients with clinical contraindications to SGB ( including allergy to local anesthetic , carotid vascular disease as defined by ipsilateral prior carotid endarterectomy or carotid stent, superficial infection at the proposed puncture site, contralateral phrenic or laryngeal nerve palsies , and severe chronic obstructive pulmonary disease )
• patients with history of atrial fibrillation

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

sara abdallah

CONTACT

01009556520; sara92abdallah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 1, 2018
• Study Start: March 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 1, 2018

Record last verified: 2018-02