Open Mitral Cardiac SurgeryNCT06476925
Role of Left Stellate Ganglion Block in Offering Myocardial Protection in On-pump Mitral Valve Replacement? A Histopathological and Clinical Assessment
A study testing sonar guided stellate ganglion injection and sonar guided stellate ganglion block in people with Open Mitral Cardiac Surgery, run by Minia University at 1 site in Egypt.
Trial summary
Can pre-operative left stellate ganglion block offer myocardial protection in on-pump mitral valve replacement? A histopathological and clinical assessment. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Open Mitral Cardiac Surgery
- What is being tested?
- sonar guided stellate ganglion injection and sonar guided stellate ganglion block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult population of both sex, between 25-50 years, will undergo elective on pump mitral valve replacement
Who cannot join
- -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).
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- Previous history of carotid endarterectomy or presence of carotid stent.
- On thrombolytic therapy.
- Severe chronic obstructive airway disease,
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Can pre-operative left stellate ganglion block offer myocardial protection in on-pump mitral valve replacement? A histopathological and clinical assessment.
- Conditions
- Open Mitral Cardiac Surgery
- Being tested
- sonar guided stellate ganglion injection, sonar guided stellate ganglion block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonar guided stellate ganglion injectionProcedure or surgery
using high frequency probe, sonar guided stellate ganglion block with 8 ml saline 0.9%
sonar guided stellate ganglion blockProcedure or surgery
using high frequency probe, sonar guided stellate ganglion block with 8 ml bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 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 Receives: Procedure: sonar guided stellate ganglion injection |
| Stellate ganglion | Active comparator | 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 Receives: Procedure: sonar guided stellate ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with microscopic myocardial injury
Biopsy from left papillary muscle to investigate microscopic evidence of cellular injury ( cytoplasmic oedema, hemorrhage and necrosis).
Measured: intra-operative
Secondary outcomes (8)
Intra-operative arrhythmia
incidence of intraoperative atrial fibrillation
Measured: intraoperatively
postoperative arrhythmia
Incidence of post operative atrial or ventricular arrhythmia
Measured: first, second and third day after bypass
Troponin I
Serum troponin I to diagnose myocardial injury
Measured: before operation, immediately after ICU admission and 3 days post-operative
Myocardial function
Ejection fraction
Measured: pre-operative, one week
weaning from mechanical ventilation
Time from ICU admission till successful extubation
Measured: 24 hours post-operative
Time of cardiopulmonary bypass
Measured: Intraoperative
Length of ICU stay
Measured: one week
Need for pacing
Measured: intraoperative and one week after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start15 Jul 2024
- Primary completion15 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Mitral Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476925
- Sponsor's protocol ID
- 1130/4/2024
- Status last verified
- Feb 2026
- First submitted
- 18 Jun 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Left Stellate Ganglion Block in Offering Myocardial Protection in On-pump Mitral Valve Replacement? A Histopathological and Clinical Assessment
- ClinicalTrials.gov ID
- NCT06476925
- Acronym / sponsor ID
- 1130/4/2024
- Conditions
- Open Mitral Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can pre-operative left stellate ganglion block offer myocardial protection in on-pump mitral valve replacement? A histopathological and clinical assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Procedure: sonar guided stellate ganglion injectionSonar 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 |
| Stellate ganglion | Active comparator | Procedure: sonar guided stellate ganglion blockSonar 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 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult population of both sex, between 25-50 years, will undergo elective on pump mitral valve replacement
Key exclusion criteria (10 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sonar guided stellate ganglion injectionusing high frequency probe, sonar guided stellate ganglion block with 8 ml saline 0.9% | Procedure or surgery | Control group |
| sonar guided stellate ganglion blockusing high frequency probe, sonar guided stellate ganglion block with 8 ml bupivacaine 0.25% | Procedure or surgery | Stellate ganglion |
Primary outcome
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).
8 secondary outcomes
Intra-operative arrhythmia
Time frame: intraoperatively
postoperative arrhythmia
Time frame: first, second and third day after bypass
Troponin I
Time frame: before operation, immediately after ICU admission and 3 days post-operative
Myocardial function
Time frame: pre-operative, one week
weaning from mechanical ventilation
Time frame: 24 hours post-operative
Time of cardiopulmonary bypass
Time frame: Intraoperative
Length of ICU stay
Time frame: one week
Need for pacing
Time frame: intraoperative and one week after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sonar guided stellate ganglion injection and sonar guided stellate ganglion block in people with Open Mitral Cardiac Surgery, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with microscopic myocardial injury (time frame: intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.