NCT02193568

Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy

A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Brain Tumor

Interventions

Type	Name	Description
PROCEDURE	Arm I (light sedation)	If patients experience excessive preoperative anxiety they will receive light sedation of midazolam 1 mg IV.In our standard practice, it is very rare that patients receive anxiolytic premedication for craniotomies, so it is unlikely that many will require midazolam. Two IVs will be placed, one for infusion of meds and one for possible resuscitation.
PROCEDURE	Arm II (intubated general anesthesia)	Receive intubated general anesthesia
PROCEDURE	Arm II (intubated general anesthesia)	Undergo craniotomy
OTHER	Arm II (intubated general anesthesia)	Ancillary studies
PROCEDURE	Arm I (light sedation)	Undergo craniotomy
OTHER	Arm I (light sedation)	Ancillary studies

Timeline

• Start date: 2014-04-30
• Primary completion: 2016-10-08
• Completion: 2019-01-24
• First posted: 2014-07-17
• Last updated: 2019-03-13

Locations

1 site across 1 country: United States