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The Effects of Different Anesthetics on Functional Connectivity

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 65 Years
Gender Male
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03343873
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Beijing Tiantan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ruquan Han, M.D., Ph.D
Principal Investigator Affiliation Department of Anesthesiology, Beijing Tiantan Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Sedation
Additional Details

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.

Arms & Interventions

Arms

Experimental: Midarolam

midarolam sensation group

Experimental: Propofol

propofol sensation group

Experimental: dexmedetomidine

dexmedetomidine sensation group

Interventions

Drug: - Midazolam

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.

Drug: - Propofol

Propofol group 1mg / kg intravenous injection, followed by 2mg / kg / h continuous intravenous injection, and maintained to the scanning process;

Drug: - Dexmedetomidine

Dexmedetomidine group with total amount of 1μg / kg, infusion time 15min, followed by 0.6μg / kg / h, and maintained to the scanning process;

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Tian Tan Hospital, Beijing, China

Status

Recruiting

Address

Beijing Tian Tan Hospital

Beijing, , 100070

Site Contact

Ruquan Han, M.D., Ph.D

ruquan.han@gmail.com

8610-59976660

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