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The Effects of Different Anesthetics on Functional Connectivity (ACTION)

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ClinicalTrials.gov Identifier: NCT03343873
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Yuming Peng, Beijing Tiantan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sedation Drug: Midazolam Drug: Propofol Drug: Dexmedetomidine Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of Different Anesthetics on Functional Connectivity in Volunteers and Patients With Brain Tumor (ACTION)
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Midarolam
midarolam sensation group
 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.
Experimental: Propofol
propofol sensation group
 Drug: Propofol
Propofol group 1mg / kg intravenous injection, followed by 2mg / kg / h continuous intravenous injection, and maintained to the scanning process;
Experimental: dexmedetomidine
dexmedetomidine sensation group
 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;


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343873


Contacts
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Contact: Ruquan Han, M.D., Ph.D 8610-67096660 ruquan.han@gmail.com

Locations
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China
Beijing Tian Tan Hospital Recruiting
Beijing, China, 100070
Contact: Ruquan Han, M.D., Ph.D    8610-59976660    ruquan.han@gmail.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Study Chair: Ruquan Han, M.D., Ph.D Department of Anesthesiology, Beijing Tiantan Hospital
More Information
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Responsible Party: Yuming Peng, associated professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03343873    
Other Study ID Numbers: 2017-7-17
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuming Peng, Beijing Tiantan Hospital:
anesthetics; fMRI; functional connectivity
Additional relevant MeSH terms:
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Midazolam
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents