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Clinical Trials/NCT03343873
NCT03343873
Recruiting
Not Applicable

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

Beijing Tiantan Hospital1 site in 1 country240 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Sedation
Sponsor
Beijing Tiantan Hospital
Enrollment
240
Locations
1
Primary Endpoint
Amplitude of Low Frequency Fluctuations(ALLF)and Regional Homogeneity(ReHo)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Beijing Tiantan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ruquan Han

professor

Beijing Tiantan Hospital

Eligibility Criteria

Inclusion Criteria

  • Male, 18 \~ 65 years old
  • Healthy Volunteer / Brain Tumor Patients
  • Senior high school and above
  • Sign informed consent

Exclusion Criteria

  • 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

Arms & Interventions

dexmedetomidine

dexmedetomidine sensation group

Intervention: Dexmedetomidine

Midarolam

midarolam sensation group

Intervention: Midazolam

Propofol

propofol sensation group

Intervention: Propofol

Outcomes

Primary Outcomes

Amplitude of Low Frequency Fluctuations(ALLF)and Regional Homogeneity(ReHo)

Time Frame: 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.

Study Sites (1)

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