Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

Overview

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.

Full Title of Study: “Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia Under Intraoperative fMRI”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 15, 2022

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=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.

Interventions

  • Drug: 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.
  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: Dexmedetomidine group
    • 1.5 µg kg-1 h-1 dexmedetomidine
  • Active Comparator: Opioid group
    • 0.9% sodium chloride injection

Clinical Trial Outcome Measures

Primary Measures

  • Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning
    • Time Frame: 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 Measures

  • Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: during operation
    • hemodynamic change of the two groups included systolic blood pressure (SBP)
  • diastolic blood pressure (DBP)
    • Time Frame: during operation
    • hemodynamic change of the two groups included diastolic blood pressure (DBP)
  • mean arterial pressure (MAP)
    • Time Frame: during operation
    • hemodynamic change of the two groups included mean arterial pressure (MAP)
  • heart rate (HR)
    • Time Frame: during operation
    • hemodynamic change of the two groups included heart rate (HR)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • China International Neuroscience Institution
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xinya Wang, Dr, Study Chair, China International Neuroscience Institute
  • Overall Contact(s)
    • Yanghai Cui, Dr, 086-010-83199270, 1055885750@qq.com

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