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Clinical Trials/NCT05500703
NCT05500703
Completed
Phase 4

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

China International Neuroscience Institution1 site in 1 country28 target enrollmentJanuary 15, 2024

Overview

Phase
Phase 4
Intervention
Dexmedetomidine Injectable Solution
Conditions
Not specified
Sponsor
China International Neuroscience Institution
Enrollment
28
Locations
1
Primary Endpoint
Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
December 20, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
China International Neuroscience Institution
Responsible Party
Sponsor

Eligibility Criteria

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;
  • depression;
  • cognitive impairment;
  • implanted with metal devices.

Arms & Interventions

Dexmedetomidine group

1.5 µg kg-1 h-1 dexmedetomidine

Intervention: Dexmedetomidine Injectable Solution

Placebo group

0.9% sodium chloride injection

Intervention: Sodium Chloride 0.9% Inj

Outcomes

Primary Outcomes

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 Outcomes

  • diastolic blood pressure (DBP)(during operation)
  • mean arterial pressure (MAP)(during operation)
  • NRS(Hour 4, Hour 12, Hour48 post-operatively)
  • Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning(during operation)
  • heart rate (HR)(during operation)
  • Measurement of analgesia relative brain regions assessed by T2-SPACE under fMRI scanning(during operation)
  • systolic blood pressure (SBP)(during operation)

Study Sites (1)

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