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Trial record 3 of 3 for:    "Brain Cancer" | "Midazolam"

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

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ClinicalTrials.gov Identifier: NCT02193568
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
James Elder, Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Adult Brain Tumor Procedure: Arm I (light sedation) Procedure: Arm II (intubated general anesthesia) Other: Arm II (intubated general anesthesia) Other: Arm I (light sedation) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection
Study Start Date : April 30, 2014
Actual Primary Completion Date : October 8, 2016
Actual Study Completion Date : January 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: Arm I (light sedation)
Patients receive light sedation (awake) and undergo craniotomy.
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.
Other Name: anesthesia

Procedure: Arm II (intubated general anesthesia)
Undergo craniotomy
Other Name: therapeutic conventional surgery

Other: Arm II (intubated general anesthesia)
Ancillary studies
Other Name: questionnaire administration

Procedure: Arm I (light sedation)
Undergo craniotomy
Other Name: therapeutic conventional surgery

Other: Arm I (light sedation)
Ancillary studies
Other Name: questionnaire administration

Active Comparator: Arm II (intubated general anesthesia)
Patients receive intubated general anesthesia and undergo craniotomy.
Procedure: Arm II (intubated general anesthesia)
Receive intubated general anesthesia
Other Name: general anesthesia

Procedure: Arm II (intubated general anesthesia)
Undergo craniotomy
Other Name: therapeutic conventional surgery

Other: Arm II (intubated general anesthesia)
Ancillary studies
Other Name: questionnaire administration

Procedure: Arm I (light sedation)
Undergo craniotomy
Other Name: therapeutic conventional surgery

Other: Arm I (light sedation)
Ancillary studies
Other Name: questionnaire administration




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Compare resource utilization between two groups [ Time Frame: Up to 1 year ]
    Compare costs of hospital stay, anesthesia, and surgery

  2. 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.

  3. 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

  4. Track patient complications during hospital stay [ Time Frame: Up to 1 year ]
    Track patient nausea/vomiting, pain, hematology/lab stability, hemodynamic stability

  5. 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 from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193568


Locations
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United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: James Elder, MD Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: James Elder, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02193568     History of Changes
Other Study ID Numbers: OSU-12161
NCI-2014-01110 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by James Elder, Ohio State University Comprehensive Cancer Center:
Supratentorial Glioma
Craniotomy
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs