Sedation
Conditions
Keywords
anesthetics; fMRI; functional connectivity
Brief summary
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
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.
Interventions
DRUGMidazolam
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.
DRUGPropofol
Propofol group 1mg / kg intravenous injection, followed by 2mg / kg / h continuous intravenous injection, and maintained to the scanning process;
DRUGDexmedetomidine
Dexmedetomidine group with total amount of 1μg / kg, infusion time 15min, followed by 0.6μg / kg / h, and maintained to the scanning process;
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amplitude of Low Frequency Fluctuations（ALLF）and Regional Homogeneity（ReHo) | 30mins after administration | The differences of amplitude of low frequency fluctuations (ALFF/Low Frequency Amplitude) and regional homogeneity（ReHo) in brain voxel - wise under anesthetic sedations. |
Countries
China
Contacts
Primary ContactRuquan Han, M.D., Ph.D
Outcome results
None listed