Case-cohort Study of Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02439164
• Other study ID #: 2014MP06
• Status: Recruiting
• Phase: N/A
• First received: April 22, 2015
• Last updated: April 25, 2016
• Start date: July 2015

Study information

• Verified date: April 2016
• Source: Beijing Tiantan Hospital
• Contact: Nan Lin, M.D.
• Email: linnan127[@]163.com
• Is FDA regulated: No
• Health authority: China: Institutional Review Board of Beijing Tiantan Hospital
• Study type: Interventional

Clinical Trial 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 case-control 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, anesthetic hypnotic propofol, and α-2 agonist dexmedetomidine exacerbate or unmask 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• Midazolam

• propofol

• Dexmedetomidine

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brain MRI of elective neurosurgery patient as a measure of glioma location	Investigator will be blinded until the end of evaluation.	1 day	No
Primary	motor and sensory function measured by 9-hole peg test	this is a focal neurologic deficits induced by sedatives	1 hour	No
Secondary	Depth of sedation measured by OAA/S	OAA/S is Observer Assessment of Sedation	1 hour	No
Secondary	Blood pressure as a measure of physiological change		1 hour	No
Secondary	Heart rate as a measure of physiological change		1 hour	No
Secondary	brain glioma pathological diagnose as a measure of tumor type		2 weeks	No