Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Light Sedation or Intubated General Anesthesia in Reducing Complications and Length of Hospital Stay in Patients With Brain Cancer Undergoing Craniotomy

Protocol: OSU-12161

Full Title

A Prospective, Single-Blinded, Randomized Study Of Awake Vs Intubated General Anesthesia In Patients Undergoing Elective Craniotomy For Supratentorial Glioma Resection

Purpose

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.

Study Objective

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.

Are you eligible?

Inclusion Criteria:

Non-pregnant females

Elective craniotomy for supratentorial brain tumors

Primary brain cancer (presumed gliomas with no radiographic or clinical evidence of metastatic disease to the brain)

First craniotomy

American Society of Anesthesiologists (ASA) I-III

Body mass index (BMI) < 35

Exclusion Criteria:

Posterior fossa tumor/approach for tumor resection requiring the prone position

Traumatic lesions/hematomas

Emergency case

Systemic disease burden with metastatic tumor to the brain

Presence of medical co-morbidities, which, in the opinion of the investigator complicates the surgical procedure or would require additional hospital stay

Necessity of awake procedure requiring intraoperative participation of patient due to the presence of the lesion in eloquent brain areas

Prisoners

Pregnant women

Brain Cancer