Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

Sponsor
China International Neuroscience Institution (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05500703
Collaborator
(none)
12
2
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexmedetomidine Injectable Solution
  • Drug: Sodium Chloride 0.9% Inj
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia Under Intraoperative fMRI
Anticipated Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Sep 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexmedetomidine group

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.

Active Comparator: Opioid group

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.

Outcome Measures

Primary Outcome Measures

  1. Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning [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

Secondary Outcome Measures

  1. Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning [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

  2. Measurement of analgesia relative brain regions assessed by T2-SPACE under fMRI scanning [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

  3. systolic blood pressure (SBP) [during operation]

    hemodynamic change of the two groups included systolic blood pressure (SBP)

  4. diastolic blood pressure (DBP) [during operation]

    hemodynamic change of the two groups included diastolic blood pressure (DBP)

  5. mean arterial pressure (MAP) [during operation]

    hemodynamic change of the two groups included mean arterial pressure (MAP)

  6. heart rate (HR) [during operation]

    hemodynamic change of the two groups included heart rate (HR)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • China International Neuroscience Institution

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
China International Neuroscience Institution
ClinicalTrials.gov Identifier:
NCT05500703
Other Study ID Numbers:
  • CINI-AD-20220706
First Posted:
Aug 15, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022