Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma

NCT02439164 | Completed Results

• 1 other identifier: 2014MP06
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Sedation in the operating room, the Post Anesthesia Care Unit and the Intensive Care Unit is common and often necessary for patients with intracranial brain tumor. Repeated neurological function assessments is needed in those locations, especially in patients with tumors in or near eloquent regions, this is to monitor their neurologic performance to determine if there are alterations that require treatment. Some slowly infiltrative low-grade gliomas near eloquent regions do not show any detectable neurologic deficits, perhaps from reorganization, but with sedation by some sedatives such as benzodiazepine midazolam and anesthetic hypnotic propofol, the disease may seem much worse resulting in inappropriately aggressive treatment. This may be especially problematic in patients undergoing awake craniotomy for tumors in eloquent regions. This is a single-center perspective study. Patients will be mildly sedated to keep them responsive and cooperative. Motor and sensory function will be evaluated before and after mild sedation. Specific benzodiazepine antagonist will be used if sedated by midazolam. The purpose of this study is to observe if commonly used benzodiazepine midazolam exacerbates or unmasks motor and sensory function in patients with intracranial eloquent area gliomas. Hypothesis: mild sedation can unmasks or exacerbate motor and sensory deficits in patients with eloquent area glioma but not in non-neurosurgical patients/healthy volunteers. If the neurologic deficits induced by benzodiazepine agonist, then can be reversed by flumazenil.

Conditions

Glioma

Keywords

sedation; eloquent area glioma; neurologic function

Outcome Measures

Primary Outcomes (1)

• Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test

  this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.

  after sedation

Secondary Outcomes (4)

• Number of Participants With OAA/S=4 After Sedation

  withing 1 hour

• Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change

  1 hour

• Heart Rate as a Measure of Physiological Change

  1 hour

• Brain Glioma Pathological Diagnose as a Measure of Tumor Type

  2 weeks

Study Arms (2)

Glioma group

EXPERIMENTAL

Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.

Drug: Midazolam

non-neurosurgical group

ACTIVE COMPARATOR

patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.

Drug: Midazolam

Interventions

Midazolam DRUG

specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used

Glioma group; non-neurosurgical group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-60 year-old
• American Society of Anesthesiology(ASA) status I\~II
• Elective craniotomy patients with supratentorial eloquent glioma diagnosed by MRI (In control group: volunteers without neuro-diseases)

You may not qualify if:

• Unable to comprehend and cooperate with the neurologic examination
• Impaired mental status
• Taking sedative drugs in the past 24 hours
• Taking pain reliever in the past 24 hours
• Drug and/or alcohol abuse
• Pregnant and/o lactating women
• Recurrent brain tumors
• Multiple brain tumors
• Accepting radiotherapy or chemotherapy
• Complicated with intracranial trauma and vascular diseases
• Complicated with grand mal epilepsy ( in midazolam group)
• Complicated with neuromuscular diseases
• Complicated with cutaneous paresthesia

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100055, China

Location

MeSH Terms

Conditions

Glioma

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Nan Lin
• Organization: Beijing Tiantan Hospital

linnan127@163.com

861067096658

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: May 8, 2015
• Study Start: May 26, 2015
• Primary Completion: March 21, 2017
• Study Completion: March 21, 2017
• Last Updated: August 25, 2017
• Results First Posted: August 25, 2017

Record last verified: 2017-07

Locations

CN (1)