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Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

Primary Purpose

Epilepsy, Radiofrequency Ablation

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine Injectable Solution
Sodium Chloride 0.9% Inj
Sponsored by
China International Neuroscience Institution
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Epilepsy

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xuanwu hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexmedetomidine group

Opioid group

Arm Description

1.5 µg kg-1 h-1 dexmedetomidine

0.9% sodium chloride injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
systolic blood pressure (SBP)
hemodynamic change of the two groups included systolic blood pressure (SBP)
diastolic blood pressure (DBP)
hemodynamic change of the two groups included diastolic blood pressure (DBP)
mean arterial pressure (MAP)
hemodynamic change of the two groups included mean arterial pressure (MAP)
heart rate (HR)
hemodynamic change of the two groups included heart rate (HR)

Full Information

First Posted
August 8, 2022
Last Updated
November 13, 2022
Sponsor
China International Neuroscience Institution
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1. Study Identification

Unique Protocol Identification Number
NCT05500703
Brief Title
Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia
Official Title
Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia Under Intraoperative fMRI
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China International Neuroscience Institution

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Radiofrequency Ablation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
1.5 µg kg-1 h-1 dexmedetomidine
Arm Title
Opioid group
Arm Type
Active Comparator
Arm Description
0.9% sodium chloride injection
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Injectable Solution
Other Intervention Name(s)
Dexmedetomidine
Intervention Description
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
Intervention Name(s)
Sodium Chloride 0.9% Inj
Other Intervention Name(s)
only opioid and Sodium Chloride as placebo administration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning
Description
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
Time Frame
during operation
Secondary Outcome Measure Information:
Title
Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning
Description
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
Time Frame
during operation
Title
Measurement of analgesia relative brain regions assessed by T2-SPACE under fMRI scanning
Description
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
Time Frame
during operation
Title
systolic blood pressure (SBP)
Description
hemodynamic change of the two groups included systolic blood pressure (SBP)
Time Frame
during operation
Title
diastolic blood pressure (DBP)
Description
hemodynamic change of the two groups included diastolic blood pressure (DBP)
Time Frame
during operation
Title
mean arterial pressure (MAP)
Description
hemodynamic change of the two groups included mean arterial pressure (MAP)
Time Frame
during operation
Title
heart rate (HR)
Description
hemodynamic change of the two groups included heart rate (HR)
Time Frame
during operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanghai Cui, Dr
Phone
086-010-83199270
Email
1055885750@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinya Wang, Dr
Organizational Affiliation
China International Neuroscience Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Xuanwu hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kedi Zhao
Phone
13651239566
Ext
86010-83199933
Email
zhaokedi@126.com
First Name & Middle Initial & Last Name & Degree
Chaoran Nie

12. IPD Sharing Statement

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Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

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