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Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia
Sponsor: China International Neuroscience Institution
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.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.
Official title: Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia Under Intraoperative fMRI
Key Details
Gender
All
Age Range
20 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2024-01-15
Completion Date
2024-12-20
Last Updated
2026-09-10
Healthy Volunteers
No
Interventions
Dexmedetomidine Injectable Solution
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% Inj
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.
Locations (1)
Xuanwu hospital
Beijing, Beijing Municipality, China