The Effects of Different Anesthetics on Functional Connectivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Midarolam

midarolam sensation group

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

propofol sensation group

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

dexmedetomidine

dexmedetomidine sensation group

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Propofol

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

Intervention Type 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;

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes