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

The Ohio State University

Status and phase: Completed; Phase 4

Conditions: Adult Brain Tumor

Treatments: Other: Arm I (light sedation); Other: Arm II (intubated general anesthesia)

Study type: Interventional

Funder types: Other

Identifiers

NCT02193568

OSU-12161

NCI-2014-01110 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Arm I (light sedation)

Experimental group

Description:

Patients receive light sedation (awake) and undergo craniotomy.

Treatment:

Other: Arm II (intubated general anesthesia)

Other: Arm I (light sedation)

Other: Arm II (intubated general anesthesia)

Other: Arm I (light sedation)

Other: Arm II (intubated general anesthesia)

Other: Arm I (light sedation)

Arm II (intubated general anesthesia)

Active Comparator group

Description:

Patients receive intubated general anesthesia and undergo craniotomy.

Treatment:

Other: Arm II (intubated general anesthesia)

Other: Arm I (light sedation)

Other: Arm II (intubated general anesthesia)

Other: Arm I (light sedation)

Other: Arm II (intubated general anesthesia)

Other: Arm I (light sedation)