<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04439058</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU R3 /2020</org_study_id>
    <nct_id>NCT04439058</nct_id>
  </id_info>
  <brief_title>Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery</brief_title>
  <official_title>Preoperative Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>wail abdelaal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effects of SGB on the cardiovascular system remain controversial since the cardiac&#xD;
      sympathetic nerves pass through the stellate ganglion. SGB is expected to have an&#xD;
      ameliorative effect on impaired coronary circulation and cardiac function and thus to be well&#xD;
      suited to the treatment of angina pectoris and myocardial infarction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      investigators chose left SGB being safer with regards conductivity changes when compared to&#xD;
      right SGB, in the present study investigators are trying to examine and compare whether&#xD;
      coronary reperfusion in patients undergoing coronary artery bypass grafting who were subject&#xD;
      to ultrasound guided left Stellate ganglion block (SGB ) performed in the induction of&#xD;
      anesthesia could decrease post cardiopulmonary bypass ischemic changes, pulmonary&#xD;
      hypertension and right ventricular dysfunction leading to enhanced recovery.&#xD;
&#xD;
      Place of work: Ain shams university hospitals cardiovascular surgery academy, Cairo, Egypt.&#xD;
&#xD;
      Number and selection of participants:&#xD;
&#xD;
      40 participants, 20 in each group (2 groups).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2020</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>US machine Mindray M5 (Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shenzhen, China.) with a linear 38-mm high frequency 10-12 MHz transducer), with an imaging depth of 4 cm. A 50-mm short bevel 22-gauge insulated stimulating needle (PAJUNK® GmbH Medizin technologie, Deutschland) was used</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in heart rate</measure>
    <time_frame>change in heart rate from base line</time_frame>
    <description>heart rate( bpm )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in Ejection Fraction</measure>
    <time_frame>change in Ejection Fraction from base line</time_frame>
    <description>Ejection Fraction(%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in blood pressure</measure>
    <time_frame>change in blood pressure from base line</time_frame>
    <description>MAP, Systemic arterial pressure ( mmHg )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in cardiac rhythm</measure>
    <time_frame>change in cardiac rhythm from base line</time_frame>
    <description>incidence of AF or VF(BPM)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>effect of preoperative stellate ganglion block on enhanced recovery after coronary arteries bypass grafting surgery</measure>
    <time_frame>change of troponin level from base line</time_frame>
    <description>measuring troponin level (ng/ml)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>Bupivacaine+lignocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>will receive ultrasound guided left stellate ganglion block just after induction of anesthesia with10 ml of bupivacaine 0,25%+ 5ml lignocaine 1%(20 patients).&#xD;
Under complete aseptic precautions an ultrasound guided left stellate ganglion block (paratracheal technique ) The patient placed in the supine position with the head in the neutral position and slightly extended.&#xD;
The US probe placed at the level of the cricoid cartilage. The transverse process of the sixth cervical vertebra identified by its prominent anterior tubercle. Also, the longus colli muscle and its overlying prevertebral fascia anterior to the C6 vertebral body and deep to the carotid artery. skin infiltration with local anesthetic, the needle 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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>will receive ultrasound guided left stellate ganglion block just after induction of anesthesia with 15 ml of normal saline (20 patients).&#xD;
US machine Mindray M5 (Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shenzhen, China.) with a linear 38-mm high frequency 10-12 MHz transducer), with an imaging depth of 4 cm. A 50-mm short bevel 22-gauge insulated stimulating needle (PAJUNK® GmbH Medizin technologie, Deutschland</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ultrasound guided left stellate ganglion block</intervention_name>
    <description>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.&#xD;
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</description>
    <arm_group_label>Bupivacaine+lignocaine</arm_group_label>
    <arm_group_label>Normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Ischemic heart disease patients age above 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        allergy to LA, severe COPD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>diaa marzouk, M.D</last_name>
    <role>Study Director</role>
    <affiliation>professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wail Abdelaal</name>
      <address>
        <city>Cairo</city>
        <zip>00202</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>wail abdelaal</investigator_full_name>
    <investigator_title>assistant professor of anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04439058
org study id: FMASU R3 /2020
nct id: NCT04439058
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: US machine Mindray M5 (Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shenzhen, China.) with a linear 38-mm high frequency 10-12 MHz transducer), with an imaging depth of 4 cm. A 50-mm short bevel 22-gauge insulated stimulating needle (PAJUNK® GmbH Medizin technologie, Deutschland) was used
primary purpose: Other
masking: Double (Participant, Investigator)
measure: change in heart rate
time frame: change in heart rate from base line
description: heart rate( bpm )
measure: change in Ejection Fraction
time frame: change in Ejection Fraction from base line
description: Ejection Fraction(%)
measure: change in blood pressure
time frame: change in blood pressure from base line
description: MAP, Systemic arterial pressure ( mmHg )
measure: change in cardiac rhythm
time frame: change in cardiac rhythm from base line
description: incidence of AF or VF(BPM)
measure: effect of preoperative stellate ganglion block on enhanced recovery after coronary arteries bypass grafting surgery
time frame: change of troponin level from base line
description: measuring troponin level (ng/ml)
arm group label: Bupivacaine+lignocaine
arm group type: Active Comparator
description: will receive ultrasound guided left stellate ganglion block just after induction of anesthesia with10 ml of bupivacaine 0,25%+ 5ml lignocaine 1%(20 patients).
Under complete aseptic precautions an ultrasound guided left stellate ganglion block (paratracheal technique ) The patient placed in the supine position with the head in the neutral position and slightly extended.
The US probe placed at the level of the cricoid cartilage. The transverse process of the sixth cervical vertebra identified by its prominent anterior tubercle. Also, the longus colli muscle and its overlying prevertebral fascia anterior to the C6 vertebral body and deep to the carotid artery. skin infiltration with local anesthetic, the needle 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
arm group label: Normal saline
arm group type: Other
description: will receive ultrasound guided left stellate ganglion block just after induction of anesthesia with 15 ml of normal saline (20 patients).
US machine Mindray M5 (Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shenzhen, China.) with a linear 38-mm high frequency 10-12 MHz transducer), with an imaging depth of 4 cm. A 50-mm short bevel 22-gauge insulated stimulating needle (PAJUNK® GmbH Medizin technologie, Deutschland
intervention type: Other
intervention name: ultrasound guided left stellate ganglion block
description: 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
arm group label: Bupivacaine+lignocaine
arm group label: Normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: diaa marzouk, M.D
role: Study Director
affiliation: professor
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: wail abdelaal
investigator title: assistant professor of anesthesia
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
sharing ipd: No