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Completed

NCT Number: NCT05500703

Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xuanwu hospital

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine Injectable Solution

Drug

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: Dexmedetomidine

Sodium Chloride 0.9% Inj

Drug

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: only opioid and Sodium Chloride as placebo administration

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. systolic blood pressure (SBP)

    Time frame: during operation

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

  4. diastolic blood pressure (DBP)

    Time frame: during operation

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

  5. mean arterial pressure (MAP)

    Time frame: during operation

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

  6. heart rate (HR)

    Time frame: during operation

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

  7. NRS

    Time frame: Hour 4, Hour 12, Hour48 post-operatively

    NRS immediately after operation at rest.(The p-NRS was an 11-point scale with 0 indicating no pain and 10 equaled worst possible pain)

Other outcomes

  1. PONV

    Time frame: Day 7 postoperatively

    modified postoperative nausea vomiting (PONV) score

Sponsors and collaborators

Lead sponsor

China International Neuroscience Institution

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2022
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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