Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500703
• Other study ID #: CINI-AD-20220706
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: August 2022
• Source: China International Neuroscience Institution
• Contact: Yanghai Cui, Dr
• Phone: 086-010-83199270
• Email: 1055885750[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 20, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Radiofrequency Ablation

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xuanwu hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China International Neuroscience Institution

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning	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	during operation
Secondary	Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning	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	during operation
Secondary	Measurement of analgesia relative brain regions assessed by T2-SPACE under fMRI scanning	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	during operation
Secondary	systolic blood pressure (SBP)	hemodynamic change of the two groups included systolic blood pressure (SBP)	during operation
Secondary	diastolic blood pressure (DBP)	hemodynamic change of the two groups included diastolic blood pressure (DBP)	during operation
Secondary	mean arterial pressure (MAP)	hemodynamic change of the two groups included mean arterial pressure (MAP)	during operation
Secondary	heart rate (HR)	hemodynamic change of the two groups included heart rate (HR)	during operation