Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

Study Overview
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Brief Summary
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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=6) and the Opioid group (OPI group) (n=6). 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.

Detailed Description
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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=6) and the Opioid group (OPI group) (n=6). 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.

Official Title
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Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia Under Intraoperative fMRI

Conditions
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Epilepsy, Radiofrequency Ablation

Intervention / Treatment
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* Drug: Dexmedetomidine Injectable Solution
* Drug: Sodium Chloride 0.9% Inj


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: pre-existing neuropsychiatric disorders; emergency surgery; coma; depression; cognitive impairment; implanted with metal devices.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine group<br>1.5 µg kg-1 h-1 dexmedetomidine | Drug: Dexmedetomidine Injectable Solution<br>* 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.<br>* Other names: Dexmedetomidine;|
| Active Comparator: Opioid group<br>0.9% sodium chloride injection | Drug: Sodium Chloride 0.9% Inj<br>* 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.<br>* Other names: only opioid and Sodium Chloride as placebo administration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | during operation | 
| systolic blood pressure (SBP) | hemodynamic change of the two groups included systolic blood pressure (SBP) | during operation | 
| diastolic blood pressure (DBP) | hemodynamic change of the two groups included diastolic blood pressure (DBP) | during operation | 
| mean arterial pressure (MAP) | hemodynamic change of the two groups included mean arterial pressure (MAP) | during operation | 
| heart rate (HR) | hemodynamic change of the two groups included heart rate (HR) | during operation |