Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

China International Neuroscience Institution

Status and phase: Completed; Phase 4

Conditions: Epilepsy; Radiofrequency Ablation; Intracranial Surgery

Treatments: Drug: Sodium Chloride 0.9% Inj; Drug: Dexmedetomidine Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05500703

CINI-AD-20220706

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

28 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Description:

1.5 µg kg-1 h-1 dexmedetomidine

Treatment:

Drug: Dexmedetomidine Injectable Solution

Placebo group

Placebo Comparator group

Description:

0.9% sodium chloride injection

Treatment:

Drug: Sodium Chloride 0.9% Inj