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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-26

Study Completion Date

2017-03-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma

NCT04716699

Glioblastoma

COMPLETED PHASE1

Repurposing Chlorpromazine in the Treatment of Glioblastoma

NCT04224441

Glioblastoma Multiforme MGMT-Unmethylated Glioblastoma

UNKNOWN PHASE2

Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm

NCT00009854

Brain and Central Nervous System Tumors Metastatic Cancer

UNKNOWN PHASE1/PHASE2

Restrictive Use of Dexamethasone in Glioblastoma

NCT04266977

Glioblastoma Dexamethasone Steroids

RECRUITING NA

Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy (ALA SDT GLIOMA 401)

NCT06665724

Anaplastic Astrocytoma (AA) Anaplastic Oligodendroglioma (AO) Glioblastoma (GBM)

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glioma group

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

non-neurosurgical group

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Midazolam

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes