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

July 28, 2017 updated by: Nan Lin, Beijing Tiantan Hospital

Cohort Study of Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma: Comparison With a Control Group Without Intracranial Pathology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100055
        • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glioma group
Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Drug: Midazolam
specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used
Active Comparator: non-neurosurgical group
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Drug: Midazolam
specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With OAA/S=4 After Sedation
Time Frame: 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.
withing 1 hour
Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change
Time Frame: 1 hour
The MAP was measured at three time points: baseline, sedation and sedation reversal.
1 hour
Heart Rate as a Measure of Physiological Change
Time Frame: 1 hour
The HR was measured at three time points: baseline, sedation and sedation reversal.
1 hour
Brain Glioma Pathological Diagnose as a Measure of Tumor Type
Time Frame: 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)
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2015

Primary Completion (Actual)

March 21, 2017

Study Completion (Actual)

March 21, 2017

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014MP06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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