The Effects of Different Anesthetics on Functional Connectivity

Not Applicable

Recruiting

• Conditions: Sedation
• Interventions: Drug: Propofol; Drug: Dexmedetomidine; Drug: Midazolam

• Registration Number: NCT03343873
• Lead Sponsor: Beijing Tiantan Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-09-17
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

• 1. Male, 18 ~ 65 years old
• 2. Healthy Volunteer / Brain Tumor Patients
• 3. Senior high school and above
• 4. Sign informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	propofol sensation group
dexmedetomidine	Dexmedetomidine	dexmedetomidine sensation group
Midarolam	Midazolam	midarolam sensation group

Primary Outcome Measures

Name	Time	Method
Amplitude of Low Frequency Fluctuations（ALLF）and Regional Homogeneity（ReHo)	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.

Trial Locations

Locations (1)

Beijing Tian Tan Hospital; 🇨🇳 Beijing, China