<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/NCT02988804</url>
  </required_header>
  <id_info>
    <org_study_id>HCB.2016.0781</org_study_id>
    <nct_id>NCT02988804</nct_id>
  </id_info>
  <brief_title>Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery</brief_title>
  <official_title>Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion Clinic per a la Recerca Biomédica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion Clinic per a la Recerca Biomédica</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The endoscopic endonasal transsphenoidal surgery (EETS) is widely used. Although the&#xD;
      incidence of complications is low, hypertensive episodes during surgery and awakening and&#xD;
      cerebro spinal fluid (CSF) leakage have been described. The occurrence of coughing or&#xD;
      vomiting during the early postoperative period must be avoid to protect the patient from CSF&#xD;
      leakage and arterial hypertension. The emergency of anesthesia with laryngeal mask has a&#xD;
      better haemodynamic profile and less incidence of cough in some surgical procedures and it&#xD;
      could help minimizing the risks after EETS&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomization&#xD;
&#xD;
      At the end of surgery, the anesthesiologist will open a sealed envelope labeled with&#xD;
      software-generated randomized numbers to assign the patients, who will be allocated in a 1:1&#xD;
      ratio from nonstratified blocks of four patients, to one of two groups to emerge from&#xD;
      anesthesia with the ETT still in place (ETT group) or after it has been replaced by a LMA&#xD;
      (LMA group).&#xD;
&#xD;
      Study procedure&#xD;
&#xD;
      In the LMA group, after aspirating pharyngeal secretions and with the patient still under&#xD;
      general anesthesia, the investigators will insert a Proseal LMA (Laryngeal Mask Co. Ltd., Le&#xD;
      Rocher, Victoria, Mahe Seychelles) and extubate the trachea using a guided Bailey technique.&#xD;
      Specifically, the LMA will be inserted after first advancing a suction catheter along the&#xD;
      drain tube 8-10 cm beyond the distal end; the mask will be then inserted using a digital&#xD;
      technique behind the orotracheal tube, allowing the suction catheter to enter the esophagus&#xD;
      first and guiding the tip of the cuff. A number 4 or 5 mask will be chosen for patients&#xD;
      weighing 50-70 kg or 70-100 kg, respectively. The cuff will be inflated to a pressure of 60&#xD;
      cmH2O measured with a manometer. Then the orotracheal tube balloon will be deflated and the&#xD;
      tube removed. Ventilation then will be continued with the same parameters as had been used&#xD;
      earlier.&#xD;
&#xD;
      Administration of neuromuscular relaxants will be then stopped so the patient could emerge&#xD;
      from anesthesia. Once the patient recover 2/4 responses of the TOF, neostigmine (0.03 mg/Kg)&#xD;
      and atropine (0.01mg/kg) will be given to reverse the neuromuscular blockade and&#xD;
      Target-controlled infusion of anesthetics will be stopped. Lidocaine will not be&#xD;
      administrated.&#xD;
&#xD;
      Gentle manual ventilator assistance will be then provided until the patient resume&#xD;
      spontaneous breathing and respond to simple commands; the LMA or the ETT, depending on the&#xD;
      group, will be then removed.&#xD;
&#xD;
      The investigators will administer prophylaxis of nausea in the postoperative period with&#xD;
      ondansetron 4 mg/8h/iv.&#xD;
&#xD;
      In the ETT group, the procedure will be exactly the same except that the ETT will not be&#xD;
      exchanged and the patient will be directly extubated when the patient will fulfill the same&#xD;
      criteria.&#xD;
&#xD;
      Parameters&#xD;
&#xD;
      Patient variables (age, weight, height, sex) and relevant aspects of past medical history,&#xD;
      such as:&#xD;
&#xD;
        -  controlled hypertension&#xD;
&#xD;
        -  tobacco addiction&#xD;
&#xD;
        -  respiratory disease will be also registered, including sleep apnea and any chronic&#xD;
           respiratory disease (chronic bronquitis, emphysema, chronic pulmonary obstructive&#xD;
           disease).&#xD;
&#xD;
        -  cough test&#xD;
&#xD;
      Diagnosis, type of surgery, the placement of lumbar drainage.&#xD;
&#xD;
      Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:&#xD;
&#xD;
        -  baseline, in the operating room before anesthetic induction (non invasive arterial&#xD;
           pressure)&#xD;
&#xD;
        -  end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)&#xD;
&#xD;
        -  at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group&#xD;
           assignment).&#xD;
&#xD;
      The last blood pressure and HR measurements will be taken in the postoperative recovery room.&#xD;
      Respiratory variables (including end-tidal carbon dioxide concentration) will be controlled&#xD;
      during MV.&#xD;
&#xD;
        -  Neurosurgeon will rate the amount of blood in the surgical field (1: no blood; 2: small&#xD;
           bleeding that does not interfere with surgery; 3: bleeding that interferes with surgery&#xD;
           but surgery is possible; 4: bleeding that impedes normal development of surgery).&#xD;
&#xD;
        -  Any coughing episode during the first 5 minutes of awakening. Considering light coughing&#xD;
           (1 cough) and strong coughing (access of cough).&#xD;
&#xD;
        -  Preoperative xylometazoline administration.&#xD;
&#xD;
        -  Intraoperative hypertension and antihypertensive agent administered.&#xD;
&#xD;
        -  Endotracheal tube size and laryngeal mask size.&#xD;
&#xD;
        -  Difficulties in LMA ventilation.&#xD;
&#xD;
        -  Postoperative nausea or vomiting&#xD;
&#xD;
        -  CSF leakage during the admission and in the first month.&#xD;
&#xD;
        -  Postoperative bleeding.&#xD;
&#xD;
      The objective of the investigators study is evaluate the incidence of coughing and&#xD;
      hypertension during awakening in patients after EETS comparing the effect of laryngeal mask&#xD;
      vs orotracheal tube.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Actual">December 5, 2019</completion_date>
  <primary_completion_date type="Actual">November 5, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>systolic blood pressure</measure>
    <time_frame>changes from baseline systolic blood pressure in the first 60 minutes after extubation</time_frame>
    <description>Changes in systolic blood pressure comparing two methods lma vs ett</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>noradrenaline levels</measure>
    <time_frame>changes from baseline noradrenaline level at 30 minutes after awakening</time_frame>
    <description>Compare noradrenaline levels in both groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Skull Base Neoplasms</condition>
  <arm_group>
    <arm_group_label>endotracheal tube</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedure: Endotracheal tube&#xD;
Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:&#xD;
baseline, in the operating room before anesthetic induction (non invasive arterial pressure)&#xD;
end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)&#xD;
at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laryngeal mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedure: Laryngeal mask&#xD;
Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:&#xD;
baseline, in the operating room before anesthetic induction (non invasive arterial pressure)&#xD;
end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)&#xD;
at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>endotracheal tube</intervention_name>
    <description>In the Endotracheal group In the ETT group, the procedure will be exactly the same except that the ETT will not be exchanged and the patient will be directly extubated&#xD;
Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:&#xD;
baseline, in the operating room before anesthetic induction (non invasive arterial pressure)&#xD;
end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)&#xD;
at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).</description>
    <arm_group_label>endotracheal tube</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngeal mask</intervention_name>
    <description>In the LMA group, after aspirating pharyngeal secretions and with the patient still under general anesthesia, we will insert a Proseal LMA (Laryngeal Mask Co. Ltd., Le Rocher, Victoria, Mahe Seychelles) and extubate the trachea using a guided Bailey technique&#xD;
Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:&#xD;
baseline, in the operating room before anesthetic induction (non invasive arterial pressure)&#xD;
end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)&#xD;
at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).</description>
    <arm_group_label>Laryngeal mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who undergo EETS in Hospital Clínic de Barcelona&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Re-interventions&#xD;
&#xD;
          -  Predicted difficult airway (severe acromegalia, mouth opening reduction) or&#xD;
             Cormack-Lehane grade IV detected during laryngoscopy&#xD;
&#xD;
          -  Risk of bronchial aspiration (e.g., gastroesophageal reflux disease or lower cranial&#xD;
             nerve palsy)&#xD;
&#xD;
          -  Uncontrolled arterial hypertension detected during preoperative assessment&#xD;
&#xD;
          -  Contraindication for early emergence based on anaesthetic or surgical criteria or as a&#xD;
             result of complications developing during surgery&#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>Paola Hurtado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior Especialist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anesthesia department, Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08019</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>endoscopic endonasal transsphenoidal surgery</keyword>
  <keyword>laryngeal mask</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skull Base Neoplasms</mesh_term>
  </condition_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/NCT02988804
org study id: HCB.2016.0781
nct id: NCT02988804
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The endoscopic endonasal transsphenoidal surgery (EETS) is widely used. Although the
      incidence of complications is low, hypertensive episodes during surgery and awakening and
      cerebro spinal fluid (CSF) leakage have been described. The occurrence of coughing or
      vomiting during the early postoperative period must be avoid to protect the patient from CSF
      leakage and arterial hypertension. The emergency of anesthesia with laryngeal mask has a
      better haemodynamic profile and less incidence of cough in some surgical procedures and it
      could help minimizing the risks after EETS
Randomization

      At the end of surgery, the anesthesiologist will open a sealed envelope labeled with
      software-generated randomized numbers to assign the patients, who will be allocated in a 1:1
      ratio from nonstratified blocks of four patients, to one of two groups to emerge from
      anesthesia with the ETT still in place (ETT group) or after it has been replaced by a LMA
      (LMA group).

      Study procedure

      In the LMA group, after aspirating pharyngeal secretions and with the patient still under
      general anesthesia, the investigators will insert a Proseal LMA (Laryngeal Mask Co. Ltd., Le
      Rocher, Victoria, Mahe Seychelles) and extubate the trachea using a guided Bailey technique.
      Specifically, the LMA will be inserted after first advancing a suction catheter along the
      drain tube 8-10 cm beyond the distal end; the mask will be then inserted using a digital
      technique behind the orotracheal tube, allowing the suction catheter to enter the esophagus
      first and guiding the tip of the cuff. A number 4 or 5 mask will be chosen for patients
      weighing 50-70 kg or 70-100 kg, respectively. The cuff will be inflated to a pressure of 60
      cmH2O measured with a manometer. Then the orotracheal tube balloon will be deflated and the
      tube removed. Ventilation then will be continued with the same parameters as had been used
      earlier.

      Administration of neuromuscular relaxants will be then stopped so the patient could emerge
      from anesthesia. Once the patient recover 2/4 responses of the TOF, neostigmine (0.03 mg/Kg)
      and atropine (0.01mg/kg) will be given to reverse the neuromuscular blockade and
      Target-controlled infusion of anesthetics will be stopped. Lidocaine will not be
      administrated.

      Gentle manual ventilator assistance will be then provided until the patient resume
      spontaneous breathing and respond to simple commands; the LMA or the ETT, depending on the
      group, will be then removed.

      The investigators will administer prophylaxis of nausea in the postoperative period with
      ondansetron 4 mg/8h/iv.

      In the ETT group, the procedure will be exactly the same except that the ETT will not be
      exchanged and the patient will be directly extubated when the patient will fulfill the same
      criteria.

      Parameters

      Patient variables (age, weight, height, sex) and relevant aspects of past medical history,
      such as:

        -  controlled hypertension

        -  tobacco addiction

        -  respiratory disease will be also registered, including sleep apnea and any chronic
           respiratory disease (chronic bronquitis, emphysema, chronic pulmonary obstructive
           disease).

        -  cough test

      Diagnosis, type of surgery, the placement of lumbar drainage.

      Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:

        -  baseline, in the operating room before anesthetic induction (non invasive arterial
           pressure)

        -  end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)

        -  at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group
           assignment).

      The last blood pressure and HR measurements will be taken in the postoperative recovery room.
      Respiratory variables (including end-tidal carbon dioxide concentration) will be controlled
      during MV.

        -  Neurosurgeon will rate the amount of blood in the surgical field (1: no blood; 2: small
           bleeding that does not interfere with surgery; 3: bleeding that interferes with surgery
           but surgery is possible; 4: bleeding that impedes normal development of surgery).

        -  Any coughing episode during the first 5 minutes of awakening. Considering light coughing
           (1 cough) and strong coughing (access of cough).

        -  Preoperative xylometazoline administration.

        -  Intraoperative hypertension and antihypertensive agent administered.

        -  Endotracheal tube size and laryngeal mask size.

        -  Difficulties in LMA ventilation.

        -  Postoperative nausea or vomiting

        -  CSF leakage during the admission and in the first month.

        -  Postoperative bleeding.

      The objective of the investigators study is evaluate the incidence of coughing and
      hypertension during awakening in patients after EETS comparing the effect of laryngeal mask
      vs orotracheal tube.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: systolic blood pressure
time frame: changes from baseline systolic blood pressure in the first 60 minutes after extubation
description: Changes in systolic blood pressure comparing two methods lma vs ett
measure: noradrenaline levels
time frame: changes from baseline noradrenaline level at 30 minutes after awakening
description: Compare noradrenaline levels in both groups
arm group label: endotracheal tube
arm group type: Active Comparator
description: Procedure: Endotracheal tube
Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:
baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).
arm group label: Laryngeal mask
arm group type: Active Comparator
description: Procedure: Laryngeal mask
Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:
baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).
intervention type: Device
intervention name: endotracheal tube
description: In the Endotracheal group In the ETT group, the procedure will be exactly the same except that the ETT will not be exchanged and the patient will be directly extubated
Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:
baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).
arm group label: endotracheal tube
intervention type: Device
intervention name: Laryngeal mask
description: In the LMA group, after aspirating pharyngeal secretions and with the patient still under general anesthesia, we will insert a Proseal LMA (Laryngeal Mask Co. Ltd., Le Rocher, Victoria, Mahe Seychelles) and extubate the trachea using a guided Bailey technique
Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:
baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).
arm group label: Laryngeal mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paola Hurtado, MD
role: Principal Investigator
affiliation: Senior Especialist
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundacion Clinic per a la Recerca Biomédica
investigator full name: Ricard Valero
investigator title: MD, PhD
mesh term: Skull Base Neoplasms
sharing ipd: Undecided