EpilepsyPhase 4NCT05500703
Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia
A Phase 4 study testing Dexmedetomidine Injectable Solution and Sodium Chloride 0.9% Inj in people with Epilepsy and Radiofrequency Ablation, run by China International Neuroscience Institution at 1 site in China.
Trial summary
Background: Dexmedetomidine (Dex) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. This study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of Dexmedetomidine. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Epilepsy, Radiofrequency Ablation, Intracranial Surgery
- What is being tested?
- Dexmedetomidine Injectable Solution and Sodium Chloride 0.9% Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 20 Dec 2024
- Phase
- Phase 4
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of epilepsy and eligible for radiofrequency ablation
- 20-50 years old;
- American Society of Anesthesiologists rated (ASA) I-II
- body mass index (BMI)18.5~27.9 kg·m2.
Who cannot join
- pre-existing neuropsychiatric disorders;
- emergency surgery;
- coma;
- depression;
- cognitive impairment;
- implanted with metal devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia Under Intraoperative fMRI
Background: Dexmedetomidine (Dex) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. This study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of Dexmedetomidine. Methods: Select 28 patients with the proposed intraoperative MR-guided radiofrequency ablation of epilepsy. The subjects were randomized into the Dexmedetomidine group (Dex group) (n=14) and the Placebo group (PO group) (n=14). DEX group: continuous intravenously administered 1.5 µg kg-1 h-1 dexmedetomidine 15min before anesthesia induction, continuous infusion for 15min after anesthesia induction, and then Intraoperative functional magnetic resonance imaging scanning was started. PO group: the equivalent administered speed 0.9% sodium chloride was continuously pumped for 15min before anesthesia induction, then induce and intraoperative fMRI scanning started after continuous 30min infusion. The intraoperative fMIR scan results were compared and analyzed to find the unique analgesic brain regions of DEX, and the differences of the functional neuronal network of analgesia effect between the two groups.On January 8, 2024, the protocol was amended and approved by the Institutional Review Board (IRB) of China International Neuroscience Institution (Approval No. CINI-AD-20220706). In this approved amendment, to ensure a direct assessment of the most clinically meaningful patient-centered benefit, the primary outcome was redefined as postoperative pain measured by the Numerical Rating Scale (NRS) at 4, 24, and 48 hours. The pre-specified imaging measures BOLD were re-designated as secondary outcomes to explore the neural correlates of the analgesic effect. This protocol amendment was finalized prior to the enrollment of the first participant on January 15, 2024.
Read the detailed description
On January 8, 2024, the protocol was amended and approved by the Institutional Review Board (IRB) of China International Neuroscience Institution (Approval No. CINI-AD-20220706). In this approved amendment, to ensure a direct assessment of the most clinically meaningful patient-centered benefit, the primary outcome was redefined as postoperative pain measured by the Numerical Rating Scale (NRS) at 4, 24, and 48 hours. The pre-specified imaging measures BOLD were re-designated as secondary outcomes to explore the neural correlates of the analgesic effect. This protocol amendment was finalized prior to the enrollment of the first participant on January 15, 2024.
Background: Dexmedetomidine (DEX) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. This study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of Dexmedetomidine. Methods: Select 12 patients with the proposed intraoperative MR-guided radiofrequency ablation of epilepsy. The subjects were randomized into the Dexmedetomidine group (DEX group) (n=14) and the Placebo group (PO group) (n=14). DEX group: continuous intravenously administered 1.5 µg kg-1 h-1 dexmedetomidine 15min before anesthesia induction, continuous infusion for 15min after anesthesia induction, and then Intraoperative functional magnetic resonance imaging scanning was started. OPI group: the equivalent administered speed 0.9% sodium chloride was continuously pumped for 15min before anesthesia induction, then induce and intraoperative fMRI scanning started after continuous 30min infusion. The intraoperative fMIR scan results were compared and analyzed to find the unique analgesic brain regions of DEX, and the differences of the functional neuronal network of analgesia effect between the two groups.
- Conditions
- Epilepsy, Radiofrequency Ablation, Intracranial Surgery
- Being tested
- Dexmedetomidine Injectable Solution, Sodium Chloride 0.9% Inj
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injectable SolutionDrug
Also called Dexmedetomidine
continuous pump of 1.5ug / kg / h Dexmedetomidine 15min before anesthesia induction, continuous infusion for 30min after anesthesia induction, and then nuclear magnetic scanning was started.
Sodium Chloride 0.9% InjDrug
Also called only opioid and Sodium Chloride as placebo administration
the equivalent Sodium Chloride 0.9% Inj was continuously pumped before anesthesia induction, induced by opioids for 15min, and intraoperative fMRI scanning was started after continuous infusion for 30min.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | 1.5 µg kg-1 h-1 dexmedetomidine Receives: Drug: Dexmedetomidine Injectable Solution |
| Placebo group | Placebo comparator | 0.9% sodium chloride injection Receives: Drug: Sodium Chloride 0.9% Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
NRS immediately after operation at rest.(The NRS was an 11-point scale with 0 indicating no pain and 10 equaled worst possible pain)
Measured: Hour 4, Hour 24, Hour48 post-operatively
Secondary outcomes (7)
Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning
Measurement of analgesia relative brain regions inDexmedetomidine group (DEX group) and the Opioid group (OPI group) assessed by T1-MPRAGE under fMRI scanning, and compare the two group different at the same time
Measured: during operation
Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning
Measurement of analgesia relative brain regions inDexmedetomidine group (DEX group) and the Opioid group (OPI group) assessed by BOLD under fMRI scanning, and compare the two group different at the same time
Measured: during operation
Measurement of analgesia relative brain regions assessed by T2-SPACE under fMRI scanning
Measurement of analgesia relative brain regions inDexmedetomidine group (DEX group) and the Opioid group (OPI group) assessed by T2-SPACE under fMRI scanning, and compare the two group different at the same time
Measured: during operation
systolic blood pressure (SBP)
hemodynamic change of the two groups included systolic blood pressure (SBP)
Measured: during operation
diastolic blood pressure (DBP)
hemodynamic change of the two groups included diastolic blood pressure (DBP)
Measured: during operation
mean arterial pressure (MAP)
hemodynamic change of the two groups included mean arterial pressure (MAP)
Measured: during operation
heart rate (HR)
hemodynamic change of the two groups included heart rate (HR)
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start15 Jan 2024
- Primary completion15 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinya Wang, Dr, Study chair, China International Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500703
- Sponsor's protocol ID
- CINI-AD-20220706
- Status last verified
- Apr 2025
- First submitted
- 8 Aug 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia Under Intraoperative fMRI
- ClinicalTrials.gov ID
- NCT05500703
- Acronym / sponsor ID
- CINI-AD-20220706
- Conditions
- Epilepsy, Radiofrequency Ablation, Intracranial Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 15 Aug 2022 (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.
Background: Dexmedetomidine (Dex) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. This study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of Dexmedetomidine. Methods: Select 28 patients with the proposed intraoperative MR-guided radiofrequency ablation of epilepsy. The subjects were randomized into the Dexmedetomidine group (Dex group) (n=14) and the Placebo group (PO group) (n=14). DEX group: continuous intravenously administered 1.5 µg kg-1 h-1 dexmedetomidine 15min before anesthesia induction, continuous infusion for 15min after anesthesia induction, and then Intraoperative functional magnetic resonance imaging scanning was started. PO group: the equivalent administered speed 0.9% sodium chloride was continuously pumped for 15min before anesthesia induction, then induce and intraoperative fMRI scanning started after continuous 30min infusion. The intraoperative fMIR scan results were compared and analyzed to find the unique analgesic brain regions of DEX, and the differences of the functional neuronal network of analgesia effect between the two groups.On January 8, 2024, the protocol was amended and approved by the Institutional Review Board (IRB) of China International Neuroscience Institution (Approval No. CINI-AD-20220706). In this approved amendment, to ensure a direct assessment of the most clinically meaningful patient-centered benefit, the primary outcome was redefined as postoperative pain measured by the Numerical Rating Scale (NRS) at 4, 24, and 48 hours. The pre-specified imaging measures BOLD were re-designated as secondary outcomes to explore the neural correlates of the analgesic effect. This protocol amendment was finalized prior to the enrollment of the first participant on January 15, 2024.
Detailed description
On January 8, 2024, the protocol was amended and approved by the Institutional Review Board (IRB) of China International Neuroscience Institution (Approval No. CINI-AD-20220706). In this approved amendment, to ensure a direct assessment of the most clinically meaningful patient-centered benefit, the primary outcome was redefined as postoperative pain measured by the Numerical Rating Scale (NRS) at 4, 24, and 48 hours. The pre-specified imaging measures BOLD were re-designated as secondary outcomes to explore the neural correlates of the analgesic effect. This protocol amendment was finalized prior to the enrollment of the first participant on January 15, 2024.
Background: Dexmedetomidine (DEX) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. This study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of Dexmedetomidine. Methods: Select 12 patients with the proposed intraoperative MR-guided radiofrequency ablation of epilepsy. The subjects were randomized into the Dexmedetomidine group (DEX group) (n=14) and the Placebo group (PO group) (n=14). DEX group: continuous intravenously administered 1.5 µg kg-1 h-1 dexmedetomidine 15min before anesthesia induction, continuous infusion for 15min after anesthesia induction, and then Intraoperative functional magnetic resonance imaging scanning was started. OPI group: the equivalent administered speed 0.9% sodium chloride was continuously pumped for 15min before anesthesia induction, then induce and intraoperative fMRI scanning started after continuous 30min infusion. The intraoperative fMIR scan results were compared and analyzed to find the unique analgesic brain regions of DEX, and the differences of the functional neuronal network of analgesia effect between the two groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: Dexmedetomidine Injectable Solution1.5 µg kg-1 h-1 dexmedetomidine |
| Placebo group | Placebo comparator | Drug: Sodium Chloride 0.9% Inj0.9% sodium chloride injection |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of epilepsy and eligible for radiofrequency ablation
- 20-50 years old;
- American Society of Anesthesiologists rated (ASA) I-II
- body mass index (BMI)18.5~27.9 kg·m2.
Key exclusion criteria (6 listed)
- pre-existing neuropsychiatric disorders;
- emergency surgery;
- coma;
- depression;
- cognitive impairment;
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 |
|---|---|---|
| Dexmedetomidine Injectable SolutionAlso: Dexmedetomidinecontinuous pump of 1.5ug / kg / h Dexmedetomidine 15min before anesthesia induction, continuous infusion for 30min after anesthesia induction, and then nuclear magnetic scanning was started. | Drug | Dexmedetomidine group |
| Sodium Chloride 0.9% InjAlso: only opioid and Sodium Chloride as placebo administrationthe equivalent Sodium Chloride 0.9% Inj was continuously pumped before anesthesia induction, induced by opioids for 15min, and intraoperative fMRI scanning was started after continuous infusion for 30min. | Drug | Placebo group |
Primary outcome
NRS
Time frame: Hour 4, Hour 24, Hour48 post-operatively
NRS immediately after operation at rest.(The NRS was an 11-point scale with 0 indicating no pain and 10 equaled worst possible pain)
7 secondary outcomes
Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning
Time frame: during operation
Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning
Time frame: during operation
Measurement of analgesia relative brain regions assessed by T2-SPACE under fMRI scanning
Time frame: during operation
systolic blood pressure (SBP)
Time frame: during operation
diastolic blood pressure (DBP)
Time frame: during operation
mean arterial pressure (MAP)
Time frame: during operation
heart rate (HR)
Time frame: during operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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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.
Xinya Wang, Dr study chair
China International Neuroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine Injectable Solution and Sodium Chloride 0.9% Inj in people with Epilepsy and Radiofrequency Ablation, run by China International Neuroscience Institution 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 6 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: finished, as of the sponsor's last update on 10 Sep 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Hour 4, Hour 24, Hour48 post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.