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

Primary Purpose

Glioma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Midazolam
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glioma focused on measuring sedation, eloquent area glioma, neurologic function

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glioma group

non-neurosurgical group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With OAA/S=4 After Sedation
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
The MAP was measured at three time points: baseline, sedation and sedation reversal.
Heart Rate as a Measure of Physiological Change
The HR was measured at three time points: baseline, sedation and sedation reversal.
Brain Glioma Pathological Diagnose as a Measure of Tumor Type
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)

Full Information

First Posted
April 22, 2015
Last Updated
July 28, 2017
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02439164
Brief Title
Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma
Official Title
Cohort Study of Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma: Comparison With a Control Group Without Intracranial Pathology
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 26, 2015 (Actual)
Primary Completion Date
March 21, 2017 (Actual)
Study Completion Date
March 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
sedation, eloquent area glioma, neurologic function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glioma group
Arm Type
Experimental
Arm Description
Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Arm Title
non-neurosurgical group
Arm Type
Active Comparator
Arm Description
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used
Primary Outcome Measure Information:
Title
Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test
Description
this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.
Time Frame
after sedation
Secondary Outcome Measure Information:
Title
Number of Participants With OAA/S=4 After Sedation
Description
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.
Time Frame
withing 1 hour
Title
Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change
Description
The MAP was measured at three time points: baseline, sedation and sedation reversal.
Time Frame
1 hour
Title
Heart Rate as a Measure of Physiological Change
Description
The HR was measured at three time points: baseline, sedation and sedation reversal.
Time Frame
1 hour
Title
Brain Glioma Pathological Diagnose as a Measure of Tumor Type
Description
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)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100055
Country
China

12. IPD Sharing Statement

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

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