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

Not Applicable

Completed

• Conditions: Glioma
• Interventions: Drug: Midazolam

• Registration Number: NCT02439164
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Study Start: 2015-05-26
• Primary Completion: 2017-03-21
• Study Completion: 2017-03-21
• Results First Submitted: 2017-06-30
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-28
• Last Update Submitted: 2017-07-28
• Results First Posted: 2017-08-25
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glioma group	Midazolam	Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
non-neurosurgical group	Midazolam	patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.

Primary Outcome Measures

Name	Time	Method
Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test	after sedation	this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With OAA/S=4 After Sedation	withing 1 hour	OAA/S is Observer Assessment of Sedation with 5 levels (5 = alert, 4 = lethargic, 3 = aroused by voice, 2 = aroused by shaking, 1 = deep sleep), all participants have to achieve OAA/S=4 after sedation.
Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change	1 hour	The MAP was measured at three time points: baseline, sedation and sedation reversal.
Heart Rate as a Measure of Physiological Change	1 hour	The HR was measured at three time points: baseline, sedation and sedation reversal.
Brain Glioma Pathological Diagnose as a Measure of Tumor Type	2 weeks	the WHO grade and the type of glioma (WHO glioma grade I\~II is regarded as low grade glioma, WHO glioma grade III\~IV is regarded as high grade glioma)

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China