Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03343873

The Effects of Different Anesthetics on Functional Connectivity

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tian Tan Hospital

Beijing, 100070, China

Location status: Recruiting

Location contact

Ruquan Han, M.D., Ph.D

CONTACT

[email protected]

8610-59976660

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

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

Drug

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

Dexmedetomidine

Drug

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

Primary outcomes

  1. Amplitude of Low Frequency Fluctuations(ALLF)and Regional Homogeneity(ReHo)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruquan Han, M.D., Ph.D

CONTACT

[email protected]

8610-67096660

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Acronym: ACTION

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2017
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.