The Effects of Different Anesthetics on Functional Connectivity (ACTION)

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Capital Medical University

Status

Unknown

Conditions

Sedation

Treatments

Drug: Propofol
Drug: Dexmedetomidine
Drug: Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT03343873
2017-7-17

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

240 participants in 3 patient groups

Midarolam
Experimental group
Description:
midarolam sensation group
Treatment:
Drug: Midazolam
Propofol
Experimental group
Description:
propofol sensation group
Treatment:
Drug: Propofol
dexmedetomidine
Experimental group
Description:
dexmedetomidine sensation group
Treatment:
Drug: Dexmedetomidine

Trial contacts and locations

0

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Central trial contact

Ruquan Han, M.D., Ph.D

Data sourced from clinicaltrials.gov

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