Role of Left Stellate Ganglion Block in Offering Myocardial Protection in On-pump Mitral Valve Replacement? A Histopathological and Clinical Assessment

NCT ID: NCT06476925

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-02-20

Brief Summary

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Can pre-operative left stellate ganglion block offer myocardial protection in on-pump mitral valve replacement? A histopathological and clinical assessment.

Detailed Description

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Conditions

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Open Mitral Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

Sonar guided stellate ganglion injection of 8 ml of sterile saline 0.9% using high frequency probe as a placebo. Stellate ganglion is identified at the level of C6 just under the pulsation of the ipsilateral carotid artery

Group Type PLACEBO_COMPARATOR

sonar guided stellate ganglion injection

Intervention Type PROCEDURE

using high frequency probe, sonar guided stellate ganglion block with 8 ml saline 0.9%

Stellate ganglion

Sonar guided stellate ganglion injection of 8ml bupivacaine 0.25% using high frequency probe. . Stellate ganglion is identified at the level of C6 just under the pulsation of the ipsilateral carotid artery

Group Type ACTIVE_COMPARATOR

sonar guided stellate ganglion block

Intervention Type PROCEDURE

using high frequency probe, sonar guided stellate ganglion block with 8 ml bupivacaine 0.25%

Interventions

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sonar guided stellate ganglion injection

using high frequency probe, sonar guided stellate ganglion block with 8 ml saline 0.9%

Intervention Type PROCEDURE

sonar guided stellate ganglion block

using high frequency probe, sonar guided stellate ganglion block with 8 ml bupivacaine 0.25%

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult population of both sex, between 25-50 years, will undergo elective on pump mitral valve replacement

Exclusion Criteria

* -Combined valve replacement ( mitral and aortic or mitral and tricuspid valves replacement).
* Emergency valve replacement ( stuck valve, infective endocarditis).
* Pre-operative cardiomyopathy (Ejection fraction less than 45%).
* Recent myocardial infarction ( within 6 months)
* Redo mitral valve replacement.
* Pre-operative pacing, or cardioverter, any form arrhythmia ( tachy or brady).
* Previous history of carotid endarterectomy or presence of carotid stent.
* On thrombolytic therapy.
* Severe chronic obstructive airway disease,
* Patient refusal
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mina Maher

Ass professor anesthesia and pain

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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1130/4/2024

Identifier Type: -

Identifier Source: org_study_id

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