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

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

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.

Study Overview

• Status: Completed
• Conditions: Adult Brain Tumor
• Intervention / Treatment: Procedure: Arm I (light sedation); Procedure: Arm II (intubated general anesthesia); Procedure: Arm II (intubated general anesthesia); Other: Arm II (intubated general anesthesia); Procedure: Arm I (light sedation); Other: Arm I (light sedation)

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: anesthesia; Procedure: Arm II (intubated general anesthesia); Receive intubated general anesthesia; Other Names: general anesthesia; Procedure: Arm II (intubated general anesthesia); Undergo craniotomy; Other Names: therapeutic conventional surgery; Other: Arm II (intubated general anesthesia); Ancillary studies; Other Names: questionnaire administration; Procedure: Arm I (light sedation); Undergo craniotomy; Other Names: therapeutic conventional surgery; Other: Arm I (light sedation); Ancillary studies; Other Names: questionnaire administration
ACTIVE_COMPARATOR: Arm II (intubated general anesthesia); Patients receive intubated general anesthesia 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 Names: anesthesia; Procedure: Arm II (intubated general anesthesia); Receive intubated general anesthesia; Other Names: general anesthesia; Procedure: Arm II (intubated general anesthesia); Undergo craniotomy; Other Names: therapeutic conventional surgery; Other: Arm II (intubated general anesthesia); Ancillary studies; Other Names: questionnaire administration; Procedure: Arm I (light sedation); Undergo craniotomy; Other Names: therapeutic conventional surgery; Other: Arm I (light sedation); Ancillary studies; Other Names: questionnaire administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare overall hospital length of stay for patients in each of 2 arms	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.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare resource utilization between two groups	Compare costs of hospital stay, anesthesia, and surgery	Up to 1 year
Assess the frequency of post-operative delirium	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.	Up to 1 year
Measure patient perceptions	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	Up to 1 year
Track patient complications during hospital stay	Track patient nausea/vomiting, pain, hematology/lab stability, hemodynamic stability	Up to 1 year
Track re-admission and extended hospital stay rates	Tracking will be done using the EMR and follow-up calls	Up to 1 year from the date of surgery

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: James Elder, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start: April 30, 2014
• Primary Completion (ACTUAL): October 8, 2016
• Study Completion (ACTUAL): January 24, 2019

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (ESTIMATE): July 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Craniotomy; Supratentorial Glioma
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: OSU-12161; NCI-2014-01110 (REGISTRY: CTRP (Clinical Trial Reporting Program))