The Effects of Different Anesthetics on Functional Connectivity
ACTION
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 17, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 1, 2024
July 1, 2024
8.8 years
September 17, 2017
July 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Midarolam
EXPERIMENTALmidarolam sensation group
Propofol
EXPERIMENTALpropofol sensation group
dexmedetomidine
EXPERIMENTALdexmedetomidine sensation group
Interventions
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.
Propofol group 1mg / kg intravenous injection, followed by 2mg / kg / h continuous intravenous injection, and maintained to the scanning process;
Dexmedetomidine group with total amount of 1μg / kg, infusion time 15min, followed by 0.6μg / kg / h, and maintained to the scanning process;
Eligibility Criteria
You may qualify if:
- \. Male, 18 \~ 65 years old
- \. Healthy Volunteer / Brain Tumor Patients
- \. Senior high school and above
- \. Sign informed consent
You may not qualify if:
- \. In vivo implant MRI check taboo
- \. Cardiopulmonary liver and kidney and other systemic complications
- \. History of major surgical anesthesia
- \. Abuse of drugs, alcoholism history
- \. Test drug allergy history
- \. Claustrophobia
- \. Left hand
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tian Tan Hospital
Beijing, 100070, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ruquan Han, M.D., Ph.D
Department of Anesthesiology, Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
September 17, 2017
First Posted
November 17, 2017
Study Start
April 1, 2017
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
August 1, 2024
Record last verified: 2024-07