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Quality of Recovery Awake Versus Asleep Craniotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02228993
Recruitment Status : Active, not recruiting
First Posted : August 29, 2014
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
John Bebawy, Northwestern University

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
Brain Tumor

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Recovery Following Awake Craniotomy Versus Craniotomy Performed Under General Anesthesia
Study Start Date : August 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Group/Cohort
Awake Craniotomy
General Anesthesia Craniotomy



Primary Outcome Measures :
  1. Quality of Recovery (QoR-40) score [ Time Frame: 24 hours postoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult non-pregnant patients (age ≥ 18 years) undergoing Awake Craniotomy or General Anesthesia Craniotomy for elective supratentorial tumor resection.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228993


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University

Publications:

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Responsible Party: John Bebawy, Assistant Professor of Anesthesiology & Neurological Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT02228993    
Other Study ID Numbers: STU00096969
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases