Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02228993
Status:
COMPLETED
Last Update Posted:
2021-10-08
First Post:
2014-08-27
Brief Title:
Quality of Recovery Awake Versus Asleep Craniotomy
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Quality of Recovery Following Awake Craniotomy Versus Craniotomy Performed Under General Anesthesia
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients abilities to speak or move hence preserving neurologic function AC is often accomplished by direct cortical stimulation or inhibition while maintaining the patients 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None