The Effects of Different Anesthetics on Functional Connectivity

Study Overview
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Brief Summary
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This research is a prospective cohort study. The aim of the study is to determine different levels of sedative mechanism and the effect on brain functional connectivity of midazolam, dexmedetomidine and propofol.

Detailed Description
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This research will include 120 healthy volunteers and 120 brain tumor patients; the participants will be allocated into midazolam, dexmedetomidine and propofol group. Resting and task fMRI will be performed at awake (BIS>90), mild sedation (BIS 80-85), moderate sedation (BIS 65-75), deep sedation (BIS 45-55) and recovery states (BIS >90). The primary outcome of our study is the effect of different levels of sedation for brain network connection. The secondary outcomes are the effect of different levels of sedation for default, executive control, sensory and motor networks and their subnetwork connectivity; the sedation state, circulatory and respiratory parameters of the participants, and the adverse events.

Official Title
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The Effects of Different Anesthetics on Functional Connectivity in Volunteers and Patients With Brain Tumor (ACTION)

Conditions
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Sedation

Intervention / Treatment
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* Drug: Midazolam
* Drug: Propofol
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Male, 18   65 years old 2. Healthy Volunteer / Brain Tumor Patients 3. Senior high school and above 4. Sign informed consent Exclusion Criteria: 1. In vivo implant MRI check taboo 2. Cardiopulmonary liver and kidney and other systemic complications 3. History of major surgical anesthesia 4. Abuse of drugs, alcoholism history 5. Test drug allergy history 6. Claustrophobia 7. Left hand

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midarolam<br>midarolam sensation group | Drug: Midazolam<br>* Midazolam was administered intravenously at a dose of 0.1 mg / kg followed by continuous intravenous injection at 0.03 mg / kg / h and maintained until the course of the scan.<br>|
| Experimental: Propofol<br>propofol sensation group | Drug: Propofol<br>* Propofol group 1mg / kg intravenous injection, followed by 2mg / kg / h continuous intravenous injection, and maintained to the scanning process;<br>|
| Experimental: dexmedetomidine<br>dexmedetomidine sensation group | Drug: Dexmedetomidine<br>* Dexmedetomidine group with total amount of 1μg / kg, infusion time 15min, followed by 0.6μg / kg / h, and maintained to the scanning process;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of Low Frequency Fluctuations（ALLF）and Regional Homogeneity（ReHo) | The differences of amplitude of low frequency fluctuations (ALFF/Low Frequency Amplitude) and regional homogeneity（ReHo) in brain voxel - wise under anesthetic sedations. | 30mins after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthetics; fMRI; functional connectivity