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NCT02228993 · ClinicalTrials.gov registry record
Quality of Recovery Awake Versus Asleep Craniotomy
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 84
- Enrollment target
NCT02228993 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 84 participants.
The verdict
NCT02228993 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 84 participants
- Enrollment target
Study 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2014-08 |
| Est. Completion | 2021-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02228993
The ClinicalTrials.gov registry entry for NCT02228993 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02228993 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02228993 about?
NCT02228993 is a clinical study titled "Quality of Recovery Awake Versus Asleep Craniotomy". 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 f...
What is the current status of trial NCT02228993?
This trial is currently completed. The enrollment target is 84 participants. The study started on 2014-08. Estimated completion is 2021-06.
Who is sponsoring clinical trial NCT02228993?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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