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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04439058
Other study ID # FMASU R3 /2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 22, 2020
Est. completion date June 1, 2020

Study information

Verified date June 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 1, 2020
Est. primary completion date April 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Ischemic heart disease patients age above 18 years

Exclusion Criteria:

allergy to LA, severe COPD

Study Design


Intervention

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

Locations

Country Name City State
Egypt Wail Abdelaal Cairo

Sponsors (2)

Lead Sponsor Collaborator
wail abdelaal Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in heart rate heart rate( bpm ) change in heart rate from base line
Primary change in Ejection Fraction Ejection Fraction(%) change in Ejection Fraction from base line
Primary change in blood pressure MAP, Systemic arterial pressure ( mmHg ) change in blood pressure from base line
Primary change in cardiac rhythm incidence of AF or VF(BPM) change in cardiac rhythm from base line
Secondary 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
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