Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
84 participants
OBSERVATIONAL
2014-08-31
2021-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Awake Craniotomy
No interventions assigned to this group
General Anesthesia Craniotomy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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John Bebawy
Associate Professor of Anesthesiology & Neurological Surgery
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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STU00096969
Identifier Type: -
Identifier Source: org_study_id
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