<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/NCT02228993</url>
  </required_header>
  <id_info>
    <org_study_id>STU00096969</org_study_id>
    <nct_id>NCT02228993</nct_id>
  </id_info>
  <brief_title>Quality of Recovery Awake Versus Asleep Craniotomy</brief_title>
  <official_title>Quality of Recovery Following Awake Craniotomy Versus Craniotomy Performed Under General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Awake craniotomy (AC) is an anesthetic and surgical technique commonly used to resect tumors&#xD;
      involving or adjacent to the eloquent or motor cortices, those portions of the brain that are&#xD;
      responsible for language and motor skills, respectively. By mapping those areas of the brain&#xD;
      that are necessary for such functions, the neurosurgeon is able to avoid resection of&#xD;
      cortical tissue that might compromise the patient's abilities to speak or move, hence&#xD;
      preserving neurologic function. AC is often accomplished by direct cortical stimulation or&#xD;
      inhibition, while maintaining the patient's ability to interact with the operative team. The&#xD;
      anesthetic technique often involves a regional (scalp) block combined with intraoperative&#xD;
      intravenous mild sedation. In some reported instances of AC, no cortical mapping is&#xD;
      performed, and the technique is performed solely because it is thought that AC leads to a&#xD;
      better recovery profile (less pain, better neurologic outcome, and shorter hospital stay)&#xD;
      than craniotomy performed under general anesthesia.&#xD;
&#xD;
      The Quality of Recovery Score (QoR-40) is a validated, multi-parameter instrument that has&#xD;
      been used in various postoperative populations to assess the overall satisfaction and&#xD;
      well-being of patients having undergone anesthesia and surgery. Leslie et al. have reported&#xD;
      that the QoR-40 is a valid tool in assessing neurosurgical patients, but a direct comparison&#xD;
      between AC patients and general anesthesia craniotomy (GAC) patients using this tool has&#xD;
      never been performed.&#xD;
&#xD;
      AC may also be associated with better 30 and 90 day multi-parameter outcomes than GAC. The&#xD;
      well-validated Acute Short Form (SF-12) health survey, an abbreviated version of the SF-36,&#xD;
      consists of 12 items. It measures two domains, including mental and physical component&#xD;
      summaries (mental component summary and physical composite score, respectively).&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Awake craniotomy for tumor resection is associated with a better multi-parameter quality of&#xD;
      recovery in the immediate postoperative period, and better 30 and 90 day quality of life&#xD;
      outcomes, than craniotomy performed under general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">June 2021</completion_date>
  <primary_completion_date type="Actual">June 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Recovery (QoR-40) score</measure>
    <time_frame>24 hours postoperatively</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Brain Tumor</condition>
  <arm_group>
    <arm_group_label>Awake Craniotomy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>General Anesthesia Craniotomy</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult non-pregnant patients (age ≥ 18 years) undergoing Awake Craniotomy or General&#xD;
        Anesthesia Craniotomy for elective supratentorial tumor resection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult non-pregnant patients (age ≥ 18 years) undergoing AC or GAC for elective&#xD;
             supratentorial tumor resection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age, non-English speaking, pregnancy, unable to obtain&#xD;
             written informed consent, infratentorial tumors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wrede KH, Stieglitz LH, Fiferna A, Karst M, Gerganov VM, Samii M, von Gosseln HH, Ludemann WO. Patient acceptance of awake craniotomy. Clin Neurol Neurosurg. 2011 Dec;113(10):880-4. doi: 10.1016/j.clineuro.2011.06.010. Epub 2011 Jul 23.</citation>
    <PMID>21782320</PMID>
  </reference>
  <reference>
    <citation>Serletis D, Bernstein M. Prospective study of awake craniotomy used routinely and nonselectively for supratentorial tumors. J Neurosurg. 2007 Jul;107(1):1-6. doi: 10.3171/JNS-07/07/0001.</citation>
    <PMID>17639865</PMID>
  </reference>
  <reference>
    <citation>Manninen PH, Balki M, Lukitto K, Bernstein M. Patient satisfaction with awake craniotomy for tumor surgery: a comparison of remifentanil and fentanyl in conjunction with propofol. Anesth Analg. 2006 Jan;102(1):237-42. doi: 10.1213/01.ANE.0000181287.86811.5C.</citation>
    <PMID>16368836</PMID>
  </reference>
  <reference>
    <citation>Whittle IR, Midgley S, Georges H, Pringle AM, Taylor R. Patient perceptions of &quot;awake&quot; brain tumour surgery. Acta Neurochir (Wien). 2005 Mar;147(3):275-7; discussion 277. doi: 10.1007/s00701-004-0445-7.</citation>
    <PMID>15627921</PMID>
  </reference>
  <reference>
    <citation>Khu KJ, Doglietto F, Radovanovic I, Taleb F, Mendelsohn D, Zadeh G, Bernstein M. Patients' perceptions of awake and outpatient craniotomy for brain tumor: a qualitative study. J Neurosurg. 2010 May;112(5):1056-60. doi: 10.3171/2009.6.JNS09716.</citation>
    <PMID>19612973</PMID>
  </reference>
  <reference>
    <citation>Manninen PH, Tan TK. Postoperative nausea and vomiting after craniotomy for tumor surgery: a comparison between awake craniotomy and general anesthesia. J Clin Anesth. 2002 Jun;14(4):279-83. doi: 10.1016/s0952-8180(02)00354-9.</citation>
    <PMID>12088812</PMID>
  </reference>
  <reference>
    <citation>Leslie K, Troedel S, Irwin K, Pearce F, Ugoni A, Gillies R, Pemberton E, Dharmage S. Quality of recovery from anesthesia in neurosurgical patients. Anesthesiology. 2003 Nov;99(5):1158-65. doi: 10.1097/00000542-200311000-00024.</citation>
    <PMID>14576554</PMID>
  </reference>
  <reference>
    <citation>Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.</citation>
    <PMID>8623940</PMID>
  </reference>
  <reference>
    <citation>Perks A, Chakravarti S, Manninen P. Preoperative anxiety in neurosurgical patients. J Neurosurg Anesthesiol. 2009 Apr;21(2):127-30. doi: 10.1097/ANA.0b013e31819a6ca3.</citation>
    <PMID>19295391</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>John Bebawy</investigator_full_name>
    <investigator_title>Associate Professor of Anesthesiology &amp; Neurological Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</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/NCT02228993
org study id: STU00096969
nct id: NCT02228993
lead sponsor: 
has dmc: No
Awake craniotomy (AC) is an anesthetic and surgical technique commonly used to resect tumors
      involving or adjacent to the eloquent or motor cortices, those portions of the brain that are
      responsible for language and motor skills, respectively. By mapping those areas of the brain
      that are necessary for such functions, the neurosurgeon is able to avoid resection of
      cortical tissue that might compromise the patient's abilities to speak or move, hence
      preserving neurologic function. AC is often accomplished by direct cortical stimulation or
      inhibition, while maintaining the patient's ability to interact with the operative team. The
      anesthetic technique often involves a regional (scalp) block combined with intraoperative
      intravenous mild sedation. In some reported instances of AC, no cortical mapping is
      performed, and the technique is performed solely because it is thought that AC leads to a
      better recovery profile (less pain, better neurologic outcome, and shorter hospital stay)
      than craniotomy performed under general anesthesia.

      The Quality of Recovery Score (QoR-40) is a validated, multi-parameter instrument that has
      been used in various postoperative populations to assess the overall satisfaction and
      well-being of patients having undergone anesthesia and surgery. Leslie et al. have reported
      that the QoR-40 is a valid tool in assessing neurosurgical patients, but a direct comparison
      between AC patients and general anesthesia craniotomy (GAC) patients using this tool has
      never been performed.

      AC may also be associated with better 30 and 90 day multi-parameter outcomes than GAC. The
      well-validated Acute Short Form (SF-12) health survey, an abbreviated version of the SF-36,
      consists of 12 items. It measures two domains, including mental and physical component
      summaries (mental component summary and physical composite score, respectively).

      Hypothesis:

      Awake craniotomy for tumor resection is associated with a better multi-parameter quality of
      recovery in the immediate postoperative period, and better 30 and 90 day quality of life
      outcomes, than craniotomy performed under general anesthesia.
observational model: Cohort
time perspective: Prospective
measure: Quality of Recovery (QoR-40) score
time frame: 24 hours postoperatively
arm group label: Awake Craniotomy
arm group label: General Anesthesia Craniotomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
citation: Wrede KH, Stieglitz LH, Fiferna A, Karst M, Gerganov VM, Samii M, von Gosseln HH, Ludemann WO. Patient acceptance of awake craniotomy. Clin Neurol Neurosurg. 2011 Dec;113(10):880-4. doi: 10.1016/j.clineuro.2011.06.010. Epub 2011 Jul 23.
PMID: 21782320
citation: Serletis D, Bernstein M. Prospective study of awake craniotomy used routinely and nonselectively for supratentorial tumors. J Neurosurg. 2007 Jul;107(1):1-6. doi: 10.3171/JNS-07/07/0001.
PMID: 17639865
citation: Manninen PH, Balki M, Lukitto K, Bernstein M. Patient satisfaction with awake craniotomy for tumor surgery: a comparison of remifentanil and fentanyl in conjunction with propofol. Anesth Analg. 2006 Jan;102(1):237-42. doi: 10.1213/01.ANE.0000181287.86811.5C.
PMID: 16368836
citation: Whittle IR, Midgley S, Georges H, Pringle AM, Taylor R. Patient perceptions of "awake" brain tumour surgery. Acta Neurochir (Wien). 2005 Mar;147(3):275-7; discussion 277. doi: 10.1007/s00701-004-0445-7.
PMID: 15627921
citation: Khu KJ, Doglietto F, Radovanovic I, Taleb F, Mendelsohn D, Zadeh G, Bernstein M. Patients' perceptions of awake and outpatient craniotomy for brain tumor: a qualitative study. J Neurosurg. 2010 May;112(5):1056-60. doi: 10.3171/2009.6.JNS09716.
PMID: 19612973
citation: Manninen PH, Tan TK. Postoperative nausea and vomiting after craniotomy for tumor surgery: a comparison between awake craniotomy and general anesthesia. J Clin Anesth. 2002 Jun;14(4):279-83. doi: 10.1016/s0952-8180(02)00354-9.
PMID: 12088812
citation: Leslie K, Troedel S, Irwin K, Pearce F, Ugoni A, Gillies R, Pemberton E, Dharmage S. Quality of recovery from anesthesia in neurosurgical patients. Anesthesiology. 2003 Nov;99(5):1158-65. doi: 10.1097/00000542-200311000-00024.
PMID: 14576554
citation: Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
PMID: 8623940
citation: Perks A, Chakravarti S, Manninen P. Preoperative anxiety in neurosurgical patients. J Neurosurg Anesthesiol. 2009 Apr;21(2):127-30. doi: 10.1097/ANA.0b013e31819a6ca3.
PMID: 19295391
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: John Bebawy
investigator title: Associate Professor of Anesthesiology & Neurological Surgery
mesh term: Brain Neoplasms