Skip to main content
OpenTrials
Completed

NCT Number: NCT06476925

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Open Mitral Cardiac Surgery

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mina Raouf

Minya, Minya Governorate, 61511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sonar guided stellate ganglion injection

Procedure

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

sonar guided stellate ganglion block

Procedure

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

Primary outcomes

  1. 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

  1. Intra-operative arrhythmia

    Time frame: intraoperatively

    incidence of intraoperative atrial fibrillation

  2. postoperative arrhythmia

    Time frame: first, second and third day after bypass

    Incidence of post operative atrial or ventricular arrhythmia

  3. Troponin I

    Time frame: before operation, immediately after ICU admission and 3 days post-operative

    Serum troponin I to diagnose myocardial injury

  4. Myocardial function

    Time frame: pre-operative, one week

    Ejection fraction

  5. weaning from mechanical ventilation

    Time frame: 24 hours post-operative

    Time from ICU admission till successful extubation

  6. Time of cardiopulmonary bypass

    Time frame: Intraoperative

  7. Length of ICU stay

    Time frame: one week

  8. Need for pacing

    Time frame: intraoperative and one week after

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.