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

NCT02193568 | Completed Phase 4 DMC

• 2 other identifiers: OSU-12161NCI-2014-01110
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Brain Tumor

Keywords

Supratentorial Glioma; Craniotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Compare resource utilization between two groups

  Up to 1 year

• Assess the frequency of post-operative delirium

  Up to 1 year

• Measure patient perceptions

  Up to 1 year

• Track patient complications during hospital stay

  Up to 1 year

• Track re-admission and extended hospital stay rates

  Up to 1 year from the date of surgery

Study Arms (2)

Arm I (light sedation)

EXPERIMENTAL

Patients receive light sedation (awake) and undergo craniotomy.

Procedure: Arm I (light sedation); Procedure: Arm II (intubated general anesthesia); Other: Arm II (intubated general anesthesia); Other: Arm I (light sedation)

Arm II (intubated general anesthesia)

ACTIVE COMPARATOR

Patients receive intubated general anesthesia and undergo craniotomy.

Procedure: Arm II (intubated general anesthesia); Other: Arm II (intubated general anesthesia); Procedure: Arm I (light sedation); Other: Arm I (light sedation)

Interventions

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.

Also known as: anesthesia

Arm I (light sedation)

Arm II (intubated general anesthesia) PROCEDURE

Receive intubated general anesthesia

Also known as: general anesthesia

Arm II (intubated general anesthesia)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Anesthesia; Anesthesia, General

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• James Elder, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: July 17, 2014
• Study Start: April 30, 2014
• Primary Completion: October 8, 2016
• Study Completion: January 24, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

US (1)