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

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

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

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Other: ultrasound guided left stellate ganglion block

Detailed Description

investigators chose left SGB being safer with regards conductivity changes when compared to right SGB, in the present study investigators are trying to examine and compare whether coronary reperfusion in patients undergoing coronary artery bypass grafting who were subject to ultrasound guided left Stellate ganglion block (SGB ) performed in the induction of anesthesia could decrease post cardiopulmonary bypass ischemic changes, pulmonary hypertension and right ventricular dysfunction leading to enhanced recovery.

Place of work: Ain shams university hospitals cardiovascular surgery academy, Cairo, Egypt.

Number and selection of participants:

40 participants, 20 in each group (2 groups).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 00202
    • Wail Abdelaal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Ischemic heart disease patients age above 18 years

Exclusion Criteria:

allergy to LA, severe COPD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine+lignocaine; 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; 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
Other: Normal saline; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of preoperative stellate ganglion block on enhanced recovery after coronary arteries bypass grafting surgery	measuring troponin level (ng/ml)	change of troponin level from base line

Collaborators and Investigators

• Sponsor: wail abdelaal
• Collaborators: Ain Shams University
• Investigators: Study Director: diaa marzouk, M.D, Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: FMASU R3 /2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No