Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-04 @ 4:47 PM
Study NCT ID:
NCT02193568
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2014-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection
Status:
COMPLETED
Status Verified Date:
2019-03
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:
This randomized clinical trial studies light sedation compared with intubated general anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep sleep) in reducing complications and length of hospital stay in patients with brain cancer undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to remain awake during their surgery, while intubated general anesthesia puts patients to sleep. Surgery complication rates may be reduced if intubated general anesthesia is avoided. Additionally, patients not receiving intubated general anesthesia tend to recover more quickly after surgery. It is not yet known whether light sedation is better at reducing complications and length of hospital stay compared to intubated general anesthesia.
Detailed Description:
PRIMARY OBJECTIVES:
I. To compare the overall hospital length of stay (LOS) in patients undergoing craniotomy with light sedation vs. general anesthesia.
SECONDARY OBJECTIVES:
I. To compare resource utilization between the two groups. II. To assess the frequency of post-operative delirium. III. To measure patient perceptions. IV. To track patient complications during hospital stay - nausea/vomiting, pain, hematology/lab stability, hemodynamic stability.
V. To track re-admission and extended hospital stay rates. VI. To compare cost of both approaches.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive light sedation (awake) and undergo craniotomy.
ARM II: Patients receive intubated general anesthesia and undergo craniotomy.
After completion of study, patients are followed up at 1month and 1 year.
I. To compare the overall hospital length of stay (LOS) in patients undergoing craniotomy with light sedation vs. general anesthesia.
SECONDARY OBJECTIVES:
I. To compare resource utilization between the two groups. II. To assess the frequency of post-operative delirium. III. To measure patient perceptions. IV. To track patient complications during hospital stay - nausea/vomiting, pain, hematology/lab stability, hemodynamic stability.
V. To track re-admission and extended hospital stay rates. VI. To compare cost of both approaches.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive light sedation (awake) and undergo craniotomy.
ARM II: Patients receive intubated general anesthesia and undergo craniotomy.
After completion of study, patients are followed up at 1month and 1 year.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-01110 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |