<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/NCT03816072</url>
  </required_header>
  <id_info>
    <org_study_id>METC 2018_230</org_study_id>
    <nct_id>NCT03816072</nct_id>
  </id_info>
  <brief_title>Quantification of Dynamic and Static Cerebral Autoregulation (CA) Under Anaesthesia</brief_title>
  <acronym>SAMBA</acronym>
  <official_title>Simultaneous Quantification of Dynamic and Static Cerebral Autoregulation (CA) at Different Steady-state Mean Blood Pressures Under Anaesthesia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
      Cerebral autoregulation (CA) is the mechanism by which the brain vasculature maintains&#xD;
      constancy of cerebral blood flow (CBF). Reliable direct measurements of CBF at different&#xD;
      blood pressure levels are difficult because they are invasive and time-consuming. This type&#xD;
      of measurement to quantify CA is generally referred to as static cerebral autoregulation&#xD;
      (sCA). Alternatively, it is possible to measure CA indirectly from blood pressure&#xD;
      oscillations. Dynamic cerebral autoregulation (dCA) measures how quickly the cerebral vessels&#xD;
      react to a change in blood pressure to normalize CBF. Since the introduction of transcranial&#xD;
      Doppler ultrasound (TCD), it has become possible to estimate CBF velocity relatively easy,&#xD;
      which in turn correlates well with CBF changes. This method is widely used to quantify dCA.&#xD;
      However, it is not clear how sCA correlates with dCA over a range of physiologic mean blood&#xD;
      pressure (MBP). It is important to compare different methods of assessing CA, because&#xD;
      impaired CA may result in increased risk of perioperative complications such as stroke. In&#xD;
      this study, the investigators were interested in establishing the relationship between sCA&#xD;
      and dCA during surgery under general anesthesia. The investigators aim to compare these&#xD;
      methods during propofol and sevoflurane anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">September 23, 2019</completion_date>
  <primary_completion_date type="Actual">September 23, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients receive either propofol or sevoflurane to maintain anaesthesia. Both treatment groups receive the same phenylephrine and mechanical ventilation regimens.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in dCA after several MBP-increasing steps.</measure>
    <time_frame>Intraoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in dCA between sevoflurane and propofol at different steady-state MBP's.</measure>
    <time_frame>Intraoperatively</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Cerebrovascular Circulation</condition>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ASA-I/II patients undergoing elective, non-cardiothoracic surgery with intravenous anaesthesia (propofol).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sevoflurane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ASA-I/II patients undergoing elective, non-cardiothoracic surgery with inhalational anaesthesia (sevoflurane).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenylephrine infusion</intervention_name>
    <description>Correction of anesthesia induced hypotension with phenylephrine to obtain sCA and dCA measurements at 60, 70, 80, 90 and 100 mmHg mean blood pressure. This is achieved by stepwise increases in phenylephrine infusion dose.</description>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_label>Sevoflurane</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mechanical ventilation</intervention_name>
    <description>Patientes are mechanically ventilated at 6 bpm to obtain low frequency blood pressure oscillations (~0.1 Hz).</description>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_label>Sevoflurane</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol</description>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Sevoflurane</description>
    <arm_group_label>Sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA-I or ASA-II, willing and able to give written informed consent, scheduled for&#xD;
             elective, non-cardiothoracic surgery under general anaesthesia and age 18 years and&#xD;
             above.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient related&#xD;
&#xD;
               -  Unable/ unwilling to participate&#xD;
&#xD;
               -  ASA-III or higher&#xD;
&#xD;
               -  Age &lt; 18 years&#xD;
&#xD;
               -  History of: uncontrolled hypertension, diabetes, Parkinson's disease,&#xD;
                  uncontrolled cardiac arrhythmia, Pure autonomic failure (formerly called&#xD;
                  idiopathic orthostatic hypotension), Multiple system atrophy with autonomic&#xD;
                  failure (formerly called Shy-Drager syndrome), Addison's disease and&#xD;
                  hypopituitarism, pheochromocytoma, peripheral autonomic neuropathy (e.g., amyloid&#xD;
                  neuropathy, idiopathic autonomic neuropathy), known cardiomyopathy, extreme left&#xD;
                  ventricle hypertrophy or ejection fraction &lt; 30%, proven or suspected allergy for&#xD;
                  any of the medication used during induction of anaesthesia, malignant&#xD;
                  hyperthermia.&#xD;
&#xD;
               -  Unability to record transcranial Doppler ultrasound due to anatomical variance&#xD;
                  (~5% of population)&#xD;
&#xD;
               -  Contra-indications for intravenous or inhalational anaesthesia.&#xD;
&#xD;
               -  Contra-indications for phenylephrine: severe hypertension, peripheral vascular&#xD;
                  illness, severe hyperthyroidism&#xD;
&#xD;
               -  Simultaneous use of MAO-inhibitors, dopaminergic or vasoconstrictor ergot&#xD;
                  alkaloids (bromocriptine, cabergoline, pergolide, ergotamine, methylergometrine,&#xD;
                  methysergide), linezolid, tricyclic antidepressants, serotonin-norepinephrine&#xD;
                  reuptake inhibitors, digoxin, quinidine, oxytocin.&#xD;
&#xD;
          -  Surgery related&#xD;
&#xD;
               -  Day case surgery&#xD;
&#xD;
               -  Laparoscopy with CO2 insufflation&#xD;
&#xD;
               -  Extreme positioning during surgery (head-down/up tilt, lateral decubitus&#xD;
                  position, prone)&#xD;
&#xD;
               -  Surgery &lt; 60 minutes.&#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>Jeroen Hermanides, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam UMC, location AMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amsterdam UMC, location AMC</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>May 25, 2021</last_update_submitted>
  <last_update_submitted_qc>May 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Niek Sperna Weiland</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenylephrine</mesh_term>
    <mesh_term>Oxymetazoline</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_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/NCT03816072
org study id: METC 2018_230
nct id: NCT03816072
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cerebral autoregulation (CA) is the mechanism by which the brain vasculature maintains
      constancy of cerebral blood flow (CBF). Reliable direct measurements of CBF at different
      blood pressure levels are difficult because they are invasive and time-consuming. This type
      of measurement to quantify CA is generally referred to as static cerebral autoregulation
      (sCA). Alternatively, it is possible to measure CA indirectly from blood pressure
      oscillations. Dynamic cerebral autoregulation (dCA) measures how quickly the cerebral vessels
      react to a change in blood pressure to normalize CBF. Since the introduction of transcranial
      Doppler ultrasound (TCD), it has become possible to estimate CBF velocity relatively easy,
      which in turn correlates well with CBF changes. This method is widely used to quantify dCA.
      However, it is not clear how sCA correlates with dCA over a range of physiologic mean blood
      pressure (MBP). It is important to compare different methods of assessing CA, because
      impaired CA may result in increased risk of perioperative complications such as stroke. In
      this study, the investigators were interested in establishing the relationship between sCA
      and dCA during surgery under general anesthesia. The investigators aim to compare these
      methods during propofol and sevoflurane anesthesia.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Patients receive either propofol or sevoflurane to maintain anaesthesia. Both treatment groups receive the same phenylephrine and mechanical ventilation regimens.
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes in dCA after several MBP-increasing steps.
time frame: Intraoperatively
measure: Differences in dCA between sevoflurane and propofol at different steady-state MBP's.
time frame: Intraoperatively
arm group label: Propofol
arm group type: Active Comparator
description: ASA-I/II patients undergoing elective, non-cardiothoracic surgery with intravenous anaesthesia (propofol).
arm group label: Sevoflurane
arm group type: Active Comparator
description: ASA-I/II patients undergoing elective, non-cardiothoracic surgery with inhalational anaesthesia (sevoflurane).
intervention type: Drug
intervention name: Phenylephrine infusion
description: Correction of anesthesia induced hypotension with phenylephrine to obtain sCA and dCA measurements at 60, 70, 80, 90 and 100 mmHg mean blood pressure. This is achieved by stepwise increases in phenylephrine infusion dose.
arm group label: Propofol
arm group label: Sevoflurane
intervention type: Other
intervention name: Mechanical ventilation
description: Patientes are mechanically ventilated at 6 bpm to obtain low frequency blood pressure oscillations (~0.1 Hz).
arm group label: Propofol
arm group label: Sevoflurane
intervention type: Drug
intervention name: Propofol
description: Propofol
arm group label: Propofol
intervention type: Drug
intervention name: Sevoflurane
description: Sevoflurane
arm group label: Sevoflurane
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeroen Hermanides, Dr.
role: Principal Investigator
affiliation: Amsterdam UMC, location AMC
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Niek Sperna Weiland
investigator title: MD
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Propofol
mesh term: Sevoflurane
sharing ipd: No