Epilepsy, Radiofrequency Ablation, Intracranial Surgery
Conditions
Brief 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. 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.
Detailed description
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.
Interventions
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.
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.
Sponsors
China International Neuroscience Institution
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of epilepsy and eligible for radiofrequency ablation 2. 20-50 years old; 3. American Society of Anesthesiologists rated (ASA) I-II 4. body mass index (BMI)18.5\ 27.9 kg·m2.
Exclusion criteria
1. pre-existing neuropsychiatric disorders; 2. emergency surgery; 3. coma; 4. depression; 5. cognitive impairment; 6. implanted with metal devices.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning | during operation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning | during operation | 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 |
| Measurement of analgesia relative brain regions assessed by T2-SPACE under fMRI scanning | during operation | 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 |
| systolic blood pressure (SBP) | during operation | hemodynamic change of the two groups included systolic blood pressure (SBP) |
| mean arterial pressure (MAP) | during operation | hemodynamic change of the two groups included mean arterial pressure (MAP) |
| heart rate (HR) | during operation | hemodynamic change of the two groups included heart rate (HR) |
| NRS | Hour 4, Hour 12, Hour48 post-operatively | NRS immediately after operation at rest.(The p-NRS was an 11-point scale with 0 indicating no pain and 10 equaled worst possible pain) |
| diastolic blood pressure (DBP) | during operation | hemodynamic change of the two groups included diastolic blood pressure (DBP) |
Other
| Measure | Time frame | Description |
|---|---|---|
| PONV | Day 7 postoperatively | modified postoperative nausea vomiting (PONV) score |
Countries
China
Outcome results
None listed