NCT03343873

The Effects of Different Anesthetics on Functional Connectivity

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sedation

Interventions

Type	Name	Description
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;

Timeline

• Start date: 2017-04-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2017-11-17
• Last updated: 2024-08-01

Locations

1 site across 1 country: China