- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05500703
Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia
November 13, 2022 updated by: China International Neuroscience Institution
Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia Under Intraoperative fMRI
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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=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.
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yanghai Cui, Dr
- Phone Number: 086-010-83199270
- Email: 1055885750@qq.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100053
- Recruiting
- Xuanwu Hospital
-
Contact:
- Kedi Zhao
- Phone Number: 86010-83199933 13651239566
- Email: zhaokedi@126.com
-
Principal Investigator:
- Chaoran Nie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
- coma;
- depression;
- cognitive impairment;
- implanted with metal devices.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dexmedetomidine group
1.5 µg kg-1 h-1 dexmedetomidine
|
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.
Other Names:
|
Active Comparator: Opioid group
0.9% sodium chloride injection
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
during operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of analgesia relative brain regions assessed by T1-MPRAGE 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 T1-MPRAGE under fMRI scanning, and compare the two group different at the same time
|
during operation
|
Measurement of analgesia relative brain regions assessed by T2-SPACE 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 T2-SPACE under fMRI scanning, and compare the two group different at the same time
|
during operation
|
systolic blood pressure (SBP)
Time Frame: during operation
|
hemodynamic change of the two groups included systolic blood pressure (SBP)
|
during operation
|
diastolic blood pressure (DBP)
Time Frame: during operation
|
hemodynamic change of the two groups included diastolic blood pressure (DBP)
|
during operation
|
mean arterial pressure (MAP)
Time Frame: during operation
|
hemodynamic change of the two groups included mean arterial pressure (MAP)
|
during operation
|
heart rate (HR)
Time Frame: during operation
|
hemodynamic change of the two groups included heart rate (HR)
|
during operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xinya Wang, Dr, China International Neuroscience Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2022
Primary Completion (Anticipated)
December 15, 2022
Study Completion (Anticipated)
December 20, 2022
Study Registration Dates
First Submitted
August 8, 2022
First Submitted That Met QC Criteria
August 11, 2022
First Posted (Actual)
August 15, 2022
Study Record Updates
Last Update Posted (Actual)
November 16, 2022
Last Update Submitted That Met QC Criteria
November 13, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- CINI-AD-20220706
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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