Clinical trial NCT05500703: Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia
Official title: Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia Under Intraoperative fMRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Radiofrequency Ablation
Intracranial Surgery
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning
timeFrame: during operation
Secondary outcomes:
measure: Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning
timeFrame: during operation
measure: Measurement of analgesia relative brain regions assessed by T2-SPACE under fMRI scanning
timeFrame: during operation
measure: systolic blood pressure (SBP)
timeFrame: during operation
measure: diastolic blood pressure (DBP)
timeFrame: during operation
measure: mean arterial pressure (MAP)
timeFrame: during operation
measure: heart rate (HR)
timeFrame: during operation
measure: NRS
timeFrame: Hour 4, Hour 12, Hour48 post-operatively
Other outcomes:
measure: PONV
timeFrame: Day 7 postoperatively
Locations:
city: Beijing
country: China
facility: Xuanwu hospital
state: Beijing
Study officials:
affiliation: China International Neuroscience Institute
name: Xinya Wang, Dr
role: STUDY_CHAIR
References: