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Completed

NCT Number: NCT02439164

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100055, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 8, 2015
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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