Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

Phase 4

Completed

• Conditions: Epilepsy; Radiofrequency Ablation; Intracranial Surgery
• Interventions: Drug: Dexmedetomidine Injectable Solution; Drug: Sodium Chloride 0.9% Inj

• Registration Number: NCT05500703
• Lead Sponsor: China International Neuroscience Institution

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.

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-15
• Study Start: 2024-01-15
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine Injectable Solution	1.5 µg kg-1 h-1 dexmedetomidine
Placebo group	Sodium Chloride 0.9% Inj	0.9% sodium chloride injection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
diastolic blood pressure (DBP)	during operation	hemodynamic change of the two groups included diastolic blood pressure (DBP)
mean arterial pressure (MAP)	during operation	hemodynamic change of the two groups included mean arterial pressure (MAP)
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)
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
heart rate (HR)	during operation	hemodynamic change of the two groups included heart rate (HR)
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)

Trial Locations

Locations (1)

Xuanwu hospital; 🇨🇳 Beijing, Beijing, China