Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery

NCT04439058 | Completed

• 1 other identifier: FMASU R3 /2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of SGB on the cardiovascular system remain controversial since the cardiac sympathetic nerves pass through the stellate ganglion. SGB is expected to have an ameliorative effect on impaired coronary circulation and cardiac function and thus to be well suited to the treatment of angina pectoris and myocardial infarction

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (4)

• change in heart rate

  heart rate( bpm )

  change in heart rate from base line

• change in Ejection Fraction

  Ejection Fraction(%)

  change in Ejection Fraction from base line

• change in blood pressure

  MAP, Systemic arterial pressure ( mmHg )

  change in blood pressure from base line

• change in cardiac rhythm

  incidence of AF or VF(BPM)

  change in cardiac rhythm from base line

Secondary Outcomes (1)

• effect of preoperative stellate ganglion block on enhanced recovery after coronary arteries bypass grafting surgery

  change of troponin level from base line

Study Arms (2)

Bupivacaine+lignocaine

ACTIVE COMPARATOR

will receive ultrasound guided left stellate ganglion block just after induction of anesthesia with10 ml of bupivacaine 0,25%+ 5ml lignocaine 1%(20 patients). Under complete aseptic precautions an ultrasound guided left stellate ganglion block (paratracheal technique ) The patient placed in the supine position with the head in the neutral position and slightly extended. The US probe placed at the level of the cricoid cartilage. The transverse process of the sixth cervical vertebra identified by its prominent anterior tubercle. Also, the longus colli muscle and its overlying prevertebral fascia anterior to the C6 vertebral body and deep to the carotid artery. skin infiltration with local anesthetic, the needle inserted from lateral to medial using the in-plane technique. The aim was to inject the local anesthetics deep to the prevertebral fascia and above the longus colli

Other: ultrasound guided left stellate ganglion block

Normal saline

OTHER

will receive ultrasound guided left stellate ganglion block just after induction of anesthesia with 15 ml of normal saline (20 patients). US machine Mindray M5 (Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shenzhen, China.) with a linear 38-mm high frequency 10-12 MHz transducer), with an imaging depth of 4 cm. A 50-mm short bevel 22-gauge insulated stimulating needle (PAJUNK® GmbH Medizin technologie, Deutschland

Other: ultrasound guided left stellate ganglion block

Interventions

ultrasound guided left stellate ganglion block OTHER

Stellate Ganglion Block (SGB) has several established clinical indications Under complete aseptic precautions an ultrasound guided left stellate ganglion block was performed. (paratracheal technique ) ( ) The patient was placed in the supine position with the head in the neutral position and slightly extended. An initial scanning was done with the ultrasound to identify the structures in this area. The US probe was placed at the level of the cricoid cartilage. The transverse process of the sixth cervical vertebra was identified by its prominent anterior tubercle. Also, the longus colli muscle and its overlying prevertebral fascia were sought anterior to the C6 vertebral body and deep to the carotid artery. After skin infiltration with local anesthetic, the needle was inserted from lateral to medial using the in-plane technique. The aim was to inject the local anesthetics deep to the prevertebral fascia and above the longus colli

Bupivacaine+lignocaine; Normal saline

Eligibility Criteria

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

You may qualify if:

• Ischemic heart disease patients age above 18 years

You may not qualify if:

• allergy to LA, severe COPD

Sponsors & Collaborators

• wail abdelaal: lead
• Ain Shams University: collaborator

Study Sites (1)

Wail Abdelaal

Cairo, 00202, Egypt

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• diaa marzouk, M.D

  professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor of anesthesia

Model Details: US machine Mindray M5 (Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shenzhen, China.) with a linear 38-mm high frequency 10-12 MHz transducer), with an imaging depth of 4 cm. A 50-mm short bevel 22-gauge insulated stimulating needle (PAJUNK® GmbH Medizin technologie, Deutschland) was used

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 19, 2020
• Study Start: January 22, 2020
• Primary Completion: April 20, 2020
• Study Completion: June 1, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)