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NCT02193568 · ClinicalTrials.gov registry record · Phase 4
Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy
A Phase 4 study, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT02193568: Completed Phase 4 study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT02193568 is a Phase 4 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02193568, a Phase 4 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
Will be summarized for each arm and compared between light sedation and general anesthesia arm using two-sample test. Regression model will also be used to study the association between the length of stay and the type of anesthesia with potential confounder variables.
Interventions
- PROCEDURE Arm I (light sedation)
- PROCEDURE Arm II (intubated general anesthesia)
- OTHER Arm II (intubated general anesthesia)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-04-30 |
| Est. Completion | 2019-01-24 |
| Phase | Phase 4 |
What the finished NCT02193568 record still lists
NCT02193568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Arm I (light sedation) is the first listed.
NCT02193568 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02193568 about?
NCT02193568 is a clinical study titled "Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy". 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. Craniotom...
What is the current status of trial NCT02193568?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2014-04-30. Estimated completion is 2019-01-24.
What interventions are being tested in trial NCT02193568?
The interventions under investigation include: Arm I (light sedation) (PROCEDURE), Arm II (intubated general anesthesia) (PROCEDURE), Arm II (intubated general anesthesia) (OTHER).
Who is sponsoring clinical trial NCT02193568?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02193568's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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