Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

NCT ID: NCT05500703

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-12-20

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.

Conditions

Epilepsy; Radiofrequency Ablation; Intracranial Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Dexmedetomidine group

1.5 µg kg-1 h-1 dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine Injectable Solution

Intervention Type: DRUG

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.

Placebo group

0.9% sodium chloride injection

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 0.9% Inj

Intervention Type: DRUG

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.

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine; only opioid and Sodium Chloride as placebo administration

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China International Neuroscience Institution

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinya Wang, Dr

Role: STUDY_CHAIR

China International Neuroscience Institute

Locations

Xuanwu hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CINI-AD-20220706

Identifier Type: -

Identifier Source: org_study_id