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

Primary Purpose

Ischemic Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided left stellate ganglion block
Sponsored by
wail abdelaal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ischemic Heart Disease

Eligibility Criteria

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

Inclusion Criteria:

Ischemic heart disease patients age above 18 years

Exclusion Criteria:

allergy to LA, severe COPD

Sites / Locations

  • Wail Abdelaal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Bupivacaine+lignocaine

Normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in heart rate
heart rate( bpm )
change in Ejection Fraction
Ejection Fraction(%)
change in blood pressure
MAP, Systemic arterial pressure ( mmHg )
change in cardiac rhythm
incidence of AF or VF(BPM)

Secondary Outcome Measures

effect of preoperative stellate ganglion block on enhanced recovery after coronary arteries bypass grafting surgery
measuring troponin level (ng/ml)

Full Information

First Posted
June 12, 2020
Last Updated
June 17, 2020
Sponsor
wail abdelaal
Collaborators
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04439058
Brief Title
Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery
Official Title
Preoperative Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
wail abdelaal
Collaborators
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine+lignocaine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Normal saline
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
ultrasound guided left stellate ganglion block
Intervention Description
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
Primary Outcome Measure Information:
Title
change in heart rate
Description
heart rate( bpm )
Time Frame
change in heart rate from base line
Title
change in Ejection Fraction
Description
Ejection Fraction(%)
Time Frame
change in Ejection Fraction from base line
Title
change in blood pressure
Description
MAP, Systemic arterial pressure ( mmHg )
Time Frame
change in blood pressure from base line
Title
change in cardiac rhythm
Description
incidence of AF or VF(BPM)
Time Frame
change in cardiac rhythm from base line
Secondary Outcome Measure Information:
Title
effect of preoperative stellate ganglion block on enhanced recovery after coronary arteries bypass grafting surgery
Description
measuring troponin level (ng/ml)
Time Frame
change of troponin level from base line

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic heart disease patients age above 18 years Exclusion Criteria: allergy to LA, severe COPD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
diaa marzouk, M.D
Organizational Affiliation
professor
Official's Role
Study Director
Facility Information:
Facility Name
Wail Abdelaal
City
Cairo
ZIP/Postal Code
00202
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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