Role of Left Stellate Ganglion Block in Offering Myocardial Protection in On-pump Mitral Valve Replacement? A Histopathological and Clinical Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Number of patients with microscopic myocardial injury
Study Overview
Brief Summary
Can pre-operative left stellate ganglion block offer myocardial protection in on-pump mitral valve replacement? A histopathological and clinical assessment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: sonar guided stellate ganglion injection (Procedure)
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
Intervention: sonar guided stellate ganglion block (Procedure)
Outcomes
Primary Outcomes
Number of patients with microscopic myocardial injury
Time Frame: intra-operative
Biopsy from left papillary muscle to investigate microscopic evidence of cellular injury ( cytoplasmic oedema, hemorrhage and necrosis).
Secondary Outcomes
- postoperative arrhythmia(first, second and third day after bypass)
- Time of cardiopulmonary bypass(Intraoperative)
- Myocardial function(pre-operative, one week)
- weaning from mechanical ventilation(24 hours post-operative)
- Length of ICU stay(one week)
- Intra-operative arrhythmia(intraoperatively)
- Troponin I(before operation, immediately after ICU admission and 3 days post-operative)
- Need for pacing(intraoperative and one week after)
Investigators
Mina Maher
Ass professor anesthesia and pain
Minia University