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NCT Number: NCT02193568

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

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.

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Key information

Conditions

Adult Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm I (light sedation)

Procedure

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 names: anesthesia

Arm II (intubated general anesthesia)

Procedure

Receive intubated general anesthesia

Other names: general anesthesia

Arm II (intubated general anesthesia)

Other

Ancillary studies

Other names: questionnaire administration

Arm I (light sedation)

Other

Ancillary studies

Other names: questionnaire administration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
Jul 17, 2014
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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