<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/NCT03778723</url>
  </required_header>
  <id_info>
    <org_study_id>MD ∕17.08.07</org_study_id>
    <nct_id>NCT03778723</nct_id>
  </id_info>
  <brief_title>Effect of Propofol Midazolam on Cerebral Oxygenation and Metabolism During Clipping of Ruptured Cerebral Aneurysm</brief_title>
  <official_title>Cerebral Oxygenation and Metabolism in Patients Undergoing Clipping of Cerebral Aneurysm: A Comparative Study Between Propofol-based Total Intravenous Anesthesia and Sevoflurane-based Inhalational Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Despite the theoretical benefits of i.v. agents, volatile agents remain popular. In a study&#xD;
      comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial&#xD;
      hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and ICP were&#xD;
      least with sevoflurane.&#xD;
&#xD;
      Propofol is the most commonly used intravenous anesthetic. It has many theoretical advantages&#xD;
      by reducing cerebral blood volume (CBV) and ICP and preserving both autoregulation and&#xD;
      vascular reactivity. Neurosurgical patients anaesthetized with propofol were found to have&#xD;
      lower ICP and higher CPP than those anaesthetized with isoflurane or sevoflurane.&#xD;
&#xD;
      The well known pharmacodynamic advantages of intravenous anesthetics may give this group of&#xD;
      drugs superior cerebral effects when compared with inhalation anesthetics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate the cerebral hemodynamics and global cerebral&#xD;
      oxygenation as well as the systemic hemodynamic changes using midazolam and propofol as total&#xD;
      intravenous anesthetics (TIVA) in comparison with sevoflurane anesthesia in clipping of&#xD;
      ruptured cerebral aneurysm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">December 15, 2019</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arterio-Jugular oxygen content difference</measure>
    <time_frame>Immediately before and every 30 min for 6 hour following start of surgery</time_frame>
    <description>The differences between arterial and jugular bulb oxygen contents</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimated cerebral metabolic rate for O2 (eCMRO2)</measure>
    <time_frame>Immediately before and every 30 min for 6 hour following start of surgery</time_frame>
    <description>eCMRO2=Ca- jO2 x(PaCO2 ∕ 100), Where Ca jO2 is arterio-jugular O2 content difference. PaCO2 is arterial CO2 tension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cerebral Extraction Rate of O2 (CEO2)</measure>
    <time_frame>Immediately before and every 30 min for 6 hour following start of surgery</time_frame>
    <description>Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cerebral Blood Flow equivalent (CBFe)</measure>
    <time_frame>Immediately before and every 30 min for 6 hour following start of surgery</time_frame>
    <description>: Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference. CBFe = 1 ∕CaO2-CjvO.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Immediately before and every 30 min for 6 hour following start of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial blood pressure</measure>
    <time_frame>Immediately before and every 30 min for 6 hour following start of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral oxygen saturation</measure>
    <time_frame>Immediately before and every 30 min for 6 hour following start of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central venous pressure</measure>
    <time_frame>Immediately before and every 30 min for 6 hour following start of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End tidal carbon dioxide tension</measure>
    <time_frame>Immediately before and every 30 min for 6 hour following start of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation score</measure>
    <time_frame>For 6 hours from induction of anesthesia</time_frame>
    <description>- Postoperative level of sedation of all patients will be evaluated using Ramsay sedation scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for first analgesic request from extubation</measure>
    <time_frame>For 6 hours from induction of anesthesia</time_frame>
    <description>Time for first analgesic request from extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of stay in intensive care unit</measure>
    <time_frame>For 5 days after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Ruptured Cerebral Aneurysm</condition>
  <arm_group>
    <arm_group_label>Total intravenous anesthesia (TIVA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive total intravenous anesthesia using Propofol and Midazolam</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inhalation Anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive Inhalation anesthesia using Sevoflurane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Total intravenous anesthesia (TIVA)</intervention_name>
    <description>Propofol (1.5-2 mg/kg/h) infusion, Midazolam (0.12 mg/kg/h) infusion</description>
    <arm_group_label>Total intravenous anesthesia (TIVA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inhalation Anesthesia</intervention_name>
    <description>Sevoflurane at a concentration of 2-2.5%</description>
    <arm_group_label>Inhalation Anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rescue fentanyl</intervention_name>
    <description>Fentanyl in repeated doses (50 µg) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value) are used for maintenance of analgesia</description>
    <arm_group_label>Inhalation Anesthesia</arm_group_label>
    <arm_group_label>Total intravenous anesthesia (TIVA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status III or IV.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Morbid obese patients.&#xD;
&#xD;
          -  Severe or uncompensated cardiovascular diseases&#xD;
&#xD;
          -  Severe or decompensated renal diseases&#xD;
&#xD;
          -  Severe or decompensated hepatic diseases&#xD;
&#xD;
          -  Severe or decompensated endocrinal diseases.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Postpartum&#xD;
&#xD;
          -  Lactating females&#xD;
&#xD;
          -  Allergy to one of the agents used.&#xD;
&#xD;
          -  Severely altered consciousness level.&#xD;
&#xD;
          -  Sitting or prone position during surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherif A Mousa, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammed A Ghanem, MD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sherif A Mousa</name>
      <address>
        <city>Mansourah</city>
        <state>DK</state>
        <zip>050</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03778723
org study id: MD ∕17.08.07
nct id: NCT03778723
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Despite the theoretical benefits of i.v. agents, volatile agents remain popular. In a study
      comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial
      hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and ICP were
      least with sevoflurane.

      Propofol is the most commonly used intravenous anesthetic. It has many theoretical advantages
      by reducing cerebral blood volume (CBV) and ICP and preserving both autoregulation and
      vascular reactivity. Neurosurgical patients anaesthetized with propofol were found to have
      lower ICP and higher CPP than those anaesthetized with isoflurane or sevoflurane.

      The well known pharmacodynamic advantages of intravenous anesthetics may give this group of
      drugs superior cerebral effects when compared with inhalation anesthetics.
The aim of this study is to evaluate the cerebral hemodynamics and global cerebral
      oxygenation as well as the systemic hemodynamic changes using midazolam and propofol as total
      intravenous anesthetics (TIVA) in comparison with sevoflurane anesthesia in clipping of
      ruptured cerebral aneurysm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Arterio-Jugular oxygen content difference
time frame: Immediately before and every 30 min for 6 hour following start of surgery
description: The differences between arterial and jugular bulb oxygen contents
measure: Estimated cerebral metabolic rate for O2 (eCMRO2)
time frame: Immediately before and every 30 min for 6 hour following start of surgery
description: eCMRO2=Ca- jO2 x(PaCO2 ∕ 100), Where Ca jO2 is arterio-jugular O2 content difference. PaCO2 is arterial CO2 tension
measure: Cerebral Extraction Rate of O2 (CEO2)
time frame: Immediately before and every 30 min for 6 hour following start of surgery
description: Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2
measure: Cerebral Blood Flow equivalent (CBFe)
time frame: Immediately before and every 30 min for 6 hour following start of surgery
description: : Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference. CBFe = 1 ∕CaO2-CjvO.
measure: Heart rate
time frame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Mean arterial blood pressure
time frame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Peripheral oxygen saturation
time frame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Central venous pressure
time frame: Immediately before and every 30 min for 6 hour following start of surgery
measure: End tidal carbon dioxide tension
time frame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Sedation score
time frame: For 6 hours from induction of anesthesia
description: - Postoperative level of sedation of all patients will be evaluated using Ramsay sedation scale
measure: Time for first analgesic request from extubation
time frame: For 6 hours from induction of anesthesia
description: Time for first analgesic request from extubation
measure: Duration of stay in intensive care unit
time frame: For 5 days after surgery
arm group label: Total intravenous anesthesia (TIVA)
arm group type: Experimental
description: Patients will receive total intravenous anesthesia using Propofol and Midazolam
arm group label: Inhalation Anesthesia
arm group type: Active Comparator
description: Patients will receive Inhalation anesthesia using Sevoflurane
intervention type: Drug
intervention name: Total intravenous anesthesia (TIVA)
description: Propofol (1.5-2 mg/kg/h) infusion, Midazolam (0.12 mg/kg/h) infusion
arm group label: Total intravenous anesthesia (TIVA)
intervention type: Drug
intervention name: Inhalation Anesthesia
description: Sevoflurane at a concentration of 2-2.5%
arm group label: Inhalation Anesthesia
intervention type: Drug
intervention name: Rescue fentanyl
description: Fentanyl in repeated doses (50 µg) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value) are used for maintenance of analgesia
arm group label: Inhalation Anesthesia
arm group label: Total intravenous anesthesia (TIVA)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sherif A Mousa, MD
role: Study Chair
affiliation: Professor
last name: Mohammed A Ghanem, MD
role: Study Director
affiliation: Associate Professor
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
mesh term: Fentanyl
mesh term: Anesthetics
sharing ipd: Undecided