Quality of Recovery Awake Versus Asleep Craniotomy

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT02228993
Collaborator
(none)
84
1
82
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    84 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Quality of Recovery Following Awake Craniotomy Versus Craniotomy Performed Under General Anesthesia
    Actual Study Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2021
    Actual Study Completion Date :
    Jun 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Awake Craniotomy

    General Anesthesia Craniotomy

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Recovery (QoR-40) score [24 hours postoperatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult non-pregnant patients (age ≥ 18 years) undergoing AC or GAC for elective supratentorial tumor resection.
    Exclusion Criteria:
    • Patients under 18 years of age, non-English speaking, pregnancy, unable to obtain written informed consent, infratentorial tumors.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    John Bebawy, Associate Professor of Anesthesiology & Neurological Surgery, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT02228993
    Other Study ID Numbers:
    • STU00096969
    First Posted:
    Aug 29, 2014
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021