SedationACTIONNCT03343873
The Effects of Different Anesthetics on Functional Connectivity
A study testing Midazolam, Propofol and Dexmedetomidine in people with Sedation, run by Beijing Tiantan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sedation
- What is being tested?
- Midazolam, Propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Male, 18 ~ 65 years old
- 2. Healthy Volunteer / Brain Tumor Patients
- 3. Senior high school and above
- 4. Sign informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tian Tan Hospital
Beijing, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
About this study
Official title: The Effects of Different Anesthetics on Functional Connectivity in Volunteers and Patients With Brain Tumor (ACTION)
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.
Read the 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
- Being tested
- Midazolam, Propofol, Dexmedetomidine
- Keywords
- anesthetics; fMRI; functional connectivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
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.
PropofolDrug
Propofol group 1mg / kg intravenous injection, followed by 2mg / kg / h continuous intravenous injection, and maintained to the scanning process;
DexmedetomidineDrug
Dexmedetomidine group with total amount of 1μg / kg, infusion time 15min, followed by 0.6μg / kg / h, and maintained to the scanning process;
| Study group | Role | What they receive |
|---|---|---|
| Midarolam | Experimental | midarolam sensation group Receives: Drug: Midazolam |
| Propofol | Experimental | propofol sensation group Receives: Drug: Propofol |
| dexmedetomidine | Experimental | dexmedetomidine sensation group Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30mins after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, M.D., Ph.D, Study chair, Department of Anesthesiology, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343873
- Sponsor's protocol ID
- 2017-7-17
- Acronym
- ACTION
- Status last verified
- Jul 2024
- First submitted
- 17 Sep 2017
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Jian M, Zhou L, Zhang D, Han R, Liu Y, Liu H, Zong F. Influence of Propofol-Induced Sedation on White Matter Functional Connectivity. Anesth Analg. 2026 Oct 1;143(4):886-896. doi: 10.1213/ANE.0000000000007975. Epub 2026 Feb 18.
PubMed 41707239
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Anesthetics on Functional Connectivity in Volunteers and Patients With Brain Tumor (ACTION)
- ClinicalTrials.gov ID
- NCT03343873
- Acronym / sponsor ID
- ACTION / 2017-7-17
- Conditions
- Sedation
- Keywords
- anesthetics; fMRI; functional connectivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Midarolam | Experimental | Drug: Midazolammidarolam sensation group |
| Propofol | Experimental | Drug: Propofolpropofol sensation group |
| dexmedetomidine | Experimental | Drug: Dexmedetomidinedexmedetomidine sensation group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Male, 18 ~ 65 years old
- 2. Healthy Volunteer / Brain Tumor Patients
- 3. Senior high school and above
- 4. Sign informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamMidazolam 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 | Midarolam |
| PropofolPropofol group 1mg / kg intravenous injection, followed by 2mg / kg / h continuous intravenous injection, and maintained to the scanning process; | Drug | Propofol |
| DexmedetomidineDexmedetomidine group with total amount of 1μg / kg, infusion time 15min, followed by 0.6μg / kg / h, and maintained to the scanning process; | Drug | dexmedetomidine |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 41707239Zhang J, Jian M, Zhou L, Zhang D, Han R, Liu Y, Liu H, Zong F. Influence of Propofol-Induced Sedation on White Matter Functional Connectivity. Anesth Analg. 2026 Oct 1;143(4):886-896. doi: 10.1213/ANE.0000000000007975. Epub 2026 Feb 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruquan Han, M.D., Ph.D study chair
Department of Anesthesiology, Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam, Propofol and Dexmedetomidine in people with Sedation, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, M.D., Ph.D (8610-67096660, ruquan.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of Low Frequency Fluctuations（ALLF）and Regional Homogeneity（ReHo) (time frame: 30mins after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03343873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.