<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/NCT02193568</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-12161</org_study_id>
    <secondary_id>NCI-2014-01110</secondary_id>
    <nct_id>NCT02193568</nct_id>
  </id_info>
  <brief_title>Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy</brief_title>
  <official_title>A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial studies light sedation compared with intubated general&#xD;
      anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep&#xD;
      sleep) in reducing complications and length of hospital stay in patients with brain cancer&#xD;
      undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so&#xD;
      doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to&#xD;
      remain awake during their surgery, while intubated general anesthesia puts patients to sleep.&#xD;
      Surgery complication rates may be reduced if intubated general anesthesia is avoided.&#xD;
      Additionally, patients not receiving intubated general anesthesia tend to recover more&#xD;
      quickly after surgery. It is not yet known whether light sedation is better at reducing&#xD;
      complications and length of hospital stay compared to intubated general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To compare the overall hospital length of stay (LOS) in patients undergoing craniotomy&#xD;
      with light sedation vs. general anesthesia.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To compare resource utilization between the two groups. II. To assess the frequency of&#xD;
      post-operative delirium. III. To measure patient perceptions. IV. To track patient&#xD;
      complications during hospital stay - nausea/vomiting, pain, hematology/lab stability,&#xD;
      hemodynamic stability.&#xD;
&#xD;
      V. To track re-admission and extended hospital stay rates. VI. To compare cost of both&#xD;
      approaches.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive light sedation (awake) and undergo craniotomy.&#xD;
&#xD;
      ARM II: Patients receive intubated general anesthesia and undergo craniotomy.&#xD;
&#xD;
      After completion of study, patients are followed up at 1month and 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 30, 2014</start_date>
  <completion_date type="Actual">January 24, 2019</completion_date>
  <primary_completion_date type="Actual">October 8, 2016</primary_completion_date>
  <phase>Phase 4</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare overall hospital length of stay for patients in each of 2 arms</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will be summarized for each arm and compared between light sedation and general anesthesia arm using two-sample test. Regression model will also be used to study the association between the length of stay and the type of anesthesia with potential confounder variables.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare resource utilization between two groups</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Compare costs of hospital stay, anesthesia, and surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the frequency of post-operative delirium</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Post-operative delirium will be assessed using the Memorial Delirium Assessment Scale (MDAS); a tool developed to measure the severity of delirium and reflects the main diagnostic criteria and symptoms of delirium. The MDAS is structured as a ten-item, four-point clinician-rated scale (possible range, 0-30) designed to quantify the severity of delirium in medically ill patients. A score of 13 has been recommended by the original authors as a cutoff for establishing the diagnosis of delirium.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure patient perceptions</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will be measured by asking patients about their overall positive experiences, if they understood rationale behind non-intubated craniotomy; necessary to improve outcomes and minimize complications; self-protection/preservation, if they appreciated receiving information before surgery to help them make informed decisions, and their trust in the surgeon via survey to be conducted at the conclusion of the inpatient stay, before hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Track patient complications during hospital stay</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Track patient nausea/vomiting, pain, hematology/lab stability, hemodynamic stability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Track re-admission and extended hospital stay rates</measure>
    <time_frame>Up to 1 year from the date of surgery</time_frame>
    <description>Tracking will be done using the EMR and follow-up calls</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Adult Brain Tumor</condition>
  <arm_group>
    <arm_group_label>Arm I (light sedation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive light sedation (awake) and undergo craniotomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (intubated general anesthesia)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive intubated general anesthesia and undergo craniotomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arm I (light sedation)</intervention_name>
    <description>If patients experience excessive preoperative anxiety they will receive light sedation of midazolam 1 mg IV.In our standard practice, it is very rare that patients receive anxiolytic premedication for craniotomies, so it is unlikely that many will require midazolam. Two IVs will be placed, one for infusion of meds and one for possible resuscitation.</description>
    <arm_group_label>Arm I (light sedation)</arm_group_label>
    <other_name>anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arm II (intubated general anesthesia)</intervention_name>
    <description>Receive intubated general anesthesia</description>
    <arm_group_label>Arm II (intubated general anesthesia)</arm_group_label>
    <other_name>general anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arm II (intubated general anesthesia)</intervention_name>
    <description>Undergo craniotomy</description>
    <arm_group_label>Arm I (light sedation)</arm_group_label>
    <arm_group_label>Arm II (intubated general anesthesia)</arm_group_label>
    <other_name>therapeutic conventional surgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Arm II (intubated general anesthesia)</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (light sedation)</arm_group_label>
    <arm_group_label>Arm II (intubated general anesthesia)</arm_group_label>
    <other_name>questionnaire administration</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arm I (light sedation)</intervention_name>
    <description>Undergo craniotomy</description>
    <arm_group_label>Arm I (light sedation)</arm_group_label>
    <arm_group_label>Arm II (intubated general anesthesia)</arm_group_label>
    <other_name>therapeutic conventional surgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Arm I (light sedation)</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (light sedation)</arm_group_label>
    <arm_group_label>Arm II (intubated general anesthesia)</arm_group_label>
    <other_name>questionnaire administration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-pregnant females&#xD;
&#xD;
          -  Elective craniotomy for supratentorial brain tumors&#xD;
&#xD;
          -  Primary brain cancer (presumed gliomas with no radiographic or clinical evidence of&#xD;
             metastatic disease to the brain)&#xD;
&#xD;
          -  First craniotomy&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) I-III&#xD;
&#xD;
          -  Body mass index (BMI) &lt; 35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Posterior fossa tumor/approach for tumor resection requiring the prone position&#xD;
&#xD;
          -  Traumatic lesions/hematomas&#xD;
&#xD;
          -  Emergency case&#xD;
&#xD;
          -  Systemic disease burden with metastatic tumor to the brain&#xD;
&#xD;
          -  Presence of medical co-morbidities, which, in the opinion of the investigator&#xD;
             complicates the surgical procedure or would require additional hospital stay&#xD;
&#xD;
          -  Necessity of awake procedure requiring intraoperative participation of patient due to&#xD;
             the presence of the lesion in eloquent brain areas&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Elder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>June 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>James Elder</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Supratentorial Glioma</keyword>
  <keyword>Craniotomy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT02193568
org study id: OSU-12161
secondary id: NCI-2014-01110
nct id: NCT02193568
lead sponsor: 
has dmc: Yes
This randomized clinical trial studies light sedation compared with intubated general
      anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep
      sleep) in reducing complications and length of hospital stay in patients with brain cancer
      undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so
      doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to
      remain awake during their surgery, while intubated general anesthesia puts patients to sleep.
      Surgery complication rates may be reduced if intubated general anesthesia is avoided.
      Additionally, patients not receiving intubated general anesthesia tend to recover more
      quickly after surgery. It is not yet known whether light sedation is better at reducing
      complications and length of hospital stay compared to intubated general anesthesia.
PRIMARY OBJECTIVES:

      I. To compare the overall hospital length of stay (LOS) in patients undergoing craniotomy
      with light sedation vs. general anesthesia.

      SECONDARY OBJECTIVES:

      I. To compare resource utilization between the two groups. II. To assess the frequency of
      post-operative delirium. III. To measure patient perceptions. IV. To track patient
      complications during hospital stay - nausea/vomiting, pain, hematology/lab stability,
      hemodynamic stability.

      V. To track re-admission and extended hospital stay rates. VI. To compare cost of both
      approaches.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive light sedation (awake) and undergo craniotomy.

      ARM II: Patients receive intubated general anesthesia and undergo craniotomy.

      After completion of study, patients are followed up at 1month and 1 year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Compare overall hospital length of stay for patients in each of 2 arms
time frame: Up to 1 year
description: Will be summarized for each arm and compared between light sedation and general anesthesia arm using two-sample test. Regression model will also be used to study the association between the length of stay and the type of anesthesia with potential confounder variables.
measure: Compare resource utilization between two groups
time frame: Up to 1 year
description: Compare costs of hospital stay, anesthesia, and surgery
measure: Assess the frequency of post-operative delirium
time frame: Up to 1 year
description: Post-operative delirium will be assessed using the Memorial Delirium Assessment Scale (MDAS); a tool developed to measure the severity of delirium and reflects the main diagnostic criteria and symptoms of delirium. The MDAS is structured as a ten-item, four-point clinician-rated scale (possible range, 0-30) designed to quantify the severity of delirium in medically ill patients. A score of 13 has been recommended by the original authors as a cutoff for establishing the diagnosis of delirium.
measure: Measure patient perceptions
time frame: Up to 1 year
description: Will be measured by asking patients about their overall positive experiences, if they understood rationale behind non-intubated craniotomy; necessary to improve outcomes and minimize complications; self-protection/preservation, if they appreciated receiving information before surgery to help them make informed decisions, and their trust in the surgeon via survey to be conducted at the conclusion of the inpatient stay, before hospital discharge
measure: Track patient complications during hospital stay
time frame: Up to 1 year
description: Track patient nausea/vomiting, pain, hematology/lab stability, hemodynamic stability
measure: Track re-admission and extended hospital stay rates
time frame: Up to 1 year from the date of surgery
description: Tracking will be done using the EMR and follow-up calls
arm group label: Arm I (light sedation)
arm group type: Experimental
description: Patients receive light sedation (awake) and undergo craniotomy.
arm group label: Arm II (intubated general anesthesia)
arm group type: Active Comparator
description: Patients receive intubated general anesthesia and undergo craniotomy.
intervention type: Procedure
intervention name: Arm I (light sedation)
description: If patients experience excessive preoperative anxiety they will receive light sedation of midazolam 1 mg IV.In our standard practice, it is very rare that patients receive anxiolytic premedication for craniotomies, so it is unlikely that many will require midazolam. Two IVs will be placed, one for infusion of meds and one for possible resuscitation.
arm group label: Arm I (light sedation)
other name: anesthesia
intervention type: Procedure
intervention name: Arm II (intubated general anesthesia)
description: Receive intubated general anesthesia
arm group label: Arm II (intubated general anesthesia)
other name: general anesthesia
intervention type: Procedure
intervention name: Arm II (intubated general anesthesia)
description: Undergo craniotomy
arm group label: Arm I (light sedation)
arm group label: Arm II (intubated general anesthesia)
other name: therapeutic conventional surgery
intervention type: Other
intervention name: Arm II (intubated general anesthesia)
description: Ancillary studies
arm group label: Arm I (light sedation)
arm group label: Arm II (intubated general anesthesia)
other name: questionnaire administration
intervention type: Procedure
intervention name: Arm I (light sedation)
description: Undergo craniotomy
arm group label: Arm I (light sedation)
arm group label: Arm II (intubated general anesthesia)
other name: therapeutic conventional surgery
intervention type: Other
intervention name: Arm I (light sedation)
description: Ancillary studies
arm group label: Arm I (light sedation)
arm group label: Arm II (intubated general anesthesia)
other name: questionnaire administration
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: James Elder, MD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: James Elder
investigator title: Principal Investigator
mesh term: Anesthetics