<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/NCT01718470</url>
  </required_header>
  <id_info>
    <org_study_id>LMAvsETT</org_study_id>
    <nct_id>NCT01718470</nct_id>
  </id_info>
  <brief_title>Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia</brief_title>
  <official_title>Proseal Laryngeal Mask Airway Attenuates Systemic and Cerebral Hemodynamic Response During Awakening of Neurosurgical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ricard Valero</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundacion Clinic per a la Recerca Biomédica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion Clinic per a la Recerca Biomédica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Extubation and emergence from anesthesia lead to systemic and cerebral hemodynamic changes&#xD;
      that can cause cerebral edema and hemorrhage. The hemodynamic profile on emergence is more&#xD;
      favorable if a laryngeal mask airway (LMA) is inserted before neurosurgical patients emerge&#xD;
      from anesthesia. We aimed to compare the impact of awakening neurosurgery patients after&#xD;
      insertion of a ProSeal LMA to replace the endotracheal tube (ETT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the end of surgery, the anesthesiologist opened a sealed envelope labeled with&#xD;
      software-generated randomized numbers to learn the patient's assignment to one of two groups&#xD;
      to emerge from anesthesia with the ETT still in place or after it had been replaced by an&#xD;
      LMA.&#xD;
&#xD;
      Hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute&#xD;
      before anesthetic induction; 5 minutes after the end of surgery before awakening (ETT group)&#xD;
      or before tube replacement (LMA group); and 1, 5, 10, 15, 30 and 60 min after extubation or&#xD;
      LMA removal (according to group assignment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>systolic blood pressure change</measure>
    <time_frame>1 minute before anesthesia induction, 5 minutes before extubation, and minute 1, 5, 10, 15, 30 and 60 after extubation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rate change</measure>
    <time_frame>1 minute before anesthesia induction, 5 minutes before extubation, and minutes 1,5,10,15,30 and 60 after extubation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Norepinephrine plasma concentration change</measure>
    <time_frame>1 minute before anesthesia induction, 1 minute and 30 minutes after extubation,</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Hypertension on Emergence</condition>
  <arm_group>
    <arm_group_label>Endotracheal tube</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the end of surgery, emerge from anesthesia with the ETT still in place</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laryngeal mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the end of surgery,emerge from anesthesia after ETT had been replaced by an LMA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endotracheal tube</intervention_name>
    <description>Hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute before anesthetic induction; 5 minutes after the end of surgery before awakening (ETT group) and 1, 5, 10, 15, 30 and 60 min after extubation . The last blood pressure and heart rate measurements were taken in the postoperative recovery room.</description>
    <arm_group_label>Endotracheal tube</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LMA</intervention_name>
    <description>Hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute before anesthetic induction; 5 minutes after the end of surgery before tube replacement (LMA group); and 1, 5, 10, 15, 30 and 60 min after LMA removal. The last blood pressure and heart rate measurements were taken in the postoperative recovery room.</description>
    <arm_group_label>Laryngeal mask</arm_group_label>
    <other_name>Laryngeal mask</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective craniotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficult airway&#xD;
&#xD;
          -  Uncontrolled hypertension before surgery&#xD;
&#xD;
          -  gastroesophageal reflux&#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>Perelló Laura, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesia Specialist, Anesthesia department, Hospital Clínic de Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anesthesia department, Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Bruder N, Stordeur JM, Ravussin P, Valli M, Dufour H, Bruguerolle B, Francois G. Metabolic and hemodynamic changes during recovery and tracheal extubation in neurosurgical patients: immediate versus delayed recovery. Anesth Analg. 1999 Sep;89(3):674-8. doi: 10.1097/00000539-199909000-00027.</citation>
    <PMID>10475304</PMID>
  </results_reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 30, 2012</last_update_submitted>
  <last_update_submitted_qc>October 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Clinic per a la Recerca Biomédica</investigator_affiliation>
    <investigator_full_name>Ricard Valero</investigator_full_name>
    <investigator_title>Ricard Valero M.D, Ph.D</investigator_title>
  </responsible_party>
  <keyword>Systolic blood pressure</keyword>
  <keyword>Heart rate</keyword>
  <keyword>Laryngeal mask</keyword>
  <keyword>Endotracheal tube</keyword>
  <keyword>craniotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT01718470
org study id: LMAvsETT
nct id: NCT01718470
lead sponsor: 
collaborator: 
has dmc: No
Extubation and emergence from anesthesia lead to systemic and cerebral hemodynamic changes
      that can cause cerebral edema and hemorrhage. The hemodynamic profile on emergence is more
      favorable if a laryngeal mask airway (LMA) is inserted before neurosurgical patients emerge
      from anesthesia. We aimed to compare the impact of awakening neurosurgery patients after
      insertion of a ProSeal LMA to replace the endotracheal tube (ETT).
At the end of surgery, the anesthesiologist opened a sealed envelope labeled with
      software-generated randomized numbers to learn the patient's assignment to one of two groups
      to emerge from anesthesia with the ETT still in place or after it had been replaced by an
      LMA.

      Hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute
      before anesthetic induction; 5 minutes after the end of surgery before awakening (ETT group)
      or before tube replacement (LMA group); and 1, 5, 10, 15, 30 and 60 min after extubation or
      LMA removal (according to group assignment).
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: systolic blood pressure change
time frame: 1 minute before anesthesia induction, 5 minutes before extubation, and minute 1, 5, 10, 15, 30 and 60 after extubation
measure: heart rate change
time frame: 1 minute before anesthesia induction, 5 minutes before extubation, and minutes 1,5,10,15,30 and 60 after extubation
measure: Norepinephrine plasma concentration change
time frame: 1 minute before anesthesia induction, 1 minute and 30 minutes after extubation,
arm group label: Endotracheal tube
arm group type: Active Comparator
description: At the end of surgery, emerge from anesthesia with the ETT still in place
arm group label: Laryngeal mask
arm group type: Active Comparator
description: At the end of surgery,emerge from anesthesia after ETT had been replaced by an LMA.
intervention type: Procedure
intervention name: Endotracheal tube
description: Hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute before anesthetic induction; 5 minutes after the end of surgery before awakening (ETT group) and 1, 5, 10, 15, 30 and 60 min after extubation . The last blood pressure and heart rate measurements were taken in the postoperative recovery room.
arm group label: Endotracheal tube
intervention type: Procedure
intervention name: LMA
description: Hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute before anesthetic induction; 5 minutes after the end of surgery before tube replacement (LMA group); and 1, 5, 10, 15, 30 and 60 min after LMA removal. The last blood pressure and heart rate measurements were taken in the postoperative recovery room.
arm group label: Laryngeal mask
other name: Laryngeal mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Perelló Laura, MD
role: Principal Investigator
affiliation: Anesthesia Specialist, Anesthesia department, Hospital Clínic de Barcelona
facility: 
country: Spain
citation: Bruder N, Stordeur JM, Ravussin P, Valli M, Dufour H, Bruguerolle B, Francois G. Metabolic and hemodynamic changes during recovery and tracheal extubation in neurosurgical patients: immediate versus delayed recovery. Anesth Analg. 1999 Sep;89(3):674-8. doi: 10.1097/00000539-199909000-00027.
PMID: 10475304
responsible party type: Sponsor-Investigator
investigator affiliation: Fundacion Clinic per a la Recerca Biomédica
investigator full name: Ricard Valero
investigator title: Ricard Valero M.D, Ph.D
mesh term: Hypertension