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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Ohio State University Comprehensive Cancer Center

Current Primary Outcome: Compare overall hospital length of stay for patients in each of 2 arms [ Time Frame: Up to 1 year ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Compare resource utilization between two groups [ Time Frame: Up to 1 year ]
    Compare costs of hospital stay, anesthesia, and surgery
  • Assess the frequency of post-operative delirium [ Time Frame: Up to 1 year ]
    Post-operative delirium will be assessed using the Memorial Delirium Assessment Scale (MDAS); a tool developed to measure the severity of delirium and reflects the main diagnostic criteria and symptoms of delirium. The MDAS is structured as a ten-item, four-point clinician-rated scale (possible range, 0-30) designed to quantify the severity of delirium in medically ill patients. A score of 13 has been recommended by the original authors as a cutoff for establishing the diagnosis of delirium.
  • Measure patient perceptions [ Time Frame: Up to 1 year ]
    Will be measured by asking patients about their overall positive experiences, if they understood rationale behind non-intubated craniotomy; necessary to improve outcomes and minimize complications; self-protection/preservation, if they appreciated receiving information before surgery to help them make informed decisions, and their trust in the surgeon via survey to be conducted at the conclusion of the inpatient stay, before hospital discharge
  • Track patient complications during hospital stay [ Time Frame: Up to 1 year ]
    Track patient nausea/vomiting, pain, hematology/lab stability, hemodynamic stability
  • Track re-admission and extended hospital stay rates [ Time Frame: Up to 1 year from the date of surgery ]
    Tracking will be done using the EMR and follow-up calls


Original Secondary Outcome:

  • Compare resource utilization between two groups [ Time Frame: Up to 1 year ]
    Compare costs of hospital stay, anesthesia, and surgery
  • Assess the frequency of post-operative delirium [ Time Frame: Up to 1 year ]
    Post-operative delirium will be assessed using the Memorial Delirium Assessment Scale (MDAS); a tool developed to measure the severity of delirium and reflects the main diagnostic criteria and symptoms of delirium. The MDAS is structured as a ten-item, four-point clinician-rated scale (possible range, 0-30) designed to quantify the severity of delirium in medically ill patients. A score of 13 has been recommended by the original authors as a cutoff for establishing the diagnosis of delirium.
  • Measure patient perceptions [ Time Frame: Up to 1 year ]
    Will be measured by asking patients about their overall positive experiences, if they understoodrationale behind non-intubated craniotomy; necessary to improve outcomes and minimize complications; self-protection/preservation, if they appreciated receiving information before surgery to help them make informed decisions, and their trust in the surgeon via survey to be conducted at the conclusion of the inpatient stay, before hospital discharge
  • Track patient complications during hospital stay [ Time Frame: Up to 1 year ]
    Track patient nausea/vomiting, pain, hematology/lab stability, hemodynamic stability
  • Track re-admission and extended hospital stay rates [ Time Frame: Up to 1 year from the date of surgery ]
    Tracking will be done using the EMR and follow-up calls


Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: June 19, 2014
Date Started: April 2014
Date Completion: December 2018
Last Updated: May 24, 2016
Last Verified: May 2016