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

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Brief Title

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

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 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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Compare overall hospital length of stay for patients in each of 2 arms

Secondary Outcome

 Compare resource utilization between two groups

Condition

Adult Brain Tumor

Intervention

Arm I (light sedation)

Study Arms / Comparison Groups

 Arm I (light sedation)
Description:  Patients receive light sedation (awake) and undergo craniotomy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

4

Start Date

April 30, 2014

Completion Date

January 24, 2019

Primary Completion Date

October 8, 2016

Eligibility Criteria

        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
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

James Elder, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02193568

Organization ID

OSU-12161

Secondary IDs

NCI-2014-01110

Responsible Party

Principal Investigator

Study Sponsor

Ohio State University Comprehensive Cancer Center


Study Sponsor

James Elder, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center


Verification Date

March 2019