The Effects of Different Anesthetics on Functional Connectivity

Sedation Clinical Trial

— ACTION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03343873
• Other study ID #: 2017-7-17
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2020
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, M.D., Ph.D
• Phone: 8610-67096660
• Email: ruquan.han[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation

Intervention

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.
• Propofol
Propofol group 1mg / kg intravenous injection, followed by 2mg / kg / h continuous intravenous injection, and maintained to the scanning process;
• Dexmedetomidine
Dexmedetomidine group with total amount of 1µg / kg, infusion time 15min, followed by 0.6µg / kg / h, and maintained to the scanning process;

Locations

Country	Name	City	State
China	Beijing Tian Tan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of Low Frequency Fluctuations(ALLF)and Regional Homogeneity(ReHo)	The differences of amplitude of low frequency fluctuations (ALFF/Low Frequency Amplitude) and regional homogeneity(ReHo) in brain voxel - wise under anesthetic sedations.	30mins after administration