Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

NCT05500703 | Completed Phase 4 DMC

• 1 other identifier: CINI-AD-20220706
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 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.On January 8, 2024, the protocol was amended and approved by the Institutional Review Board (IRB) of China International Neuroscience Institution (Approval No. CINI-AD-20220706). In this approved amendment, to ensure a direct assessment of the most clinically meaningful patient-centered benefit, the primary outcome was redefined as postoperative pain measured by the Numerical Rating Scale (NRS) at 4, 24, and 48 hours. The pre-specified imaging measures BOLD were re-designated as secondary outcomes to explore the neural correlates of the analgesic effect. This protocol amendment was finalized prior to the enrollment of the first participant on January 15, 2024.

Conditions

Epilepsy; Radiofrequency Ablation; Intracranial Surgery

Outcome Measures

Primary Outcomes (1)

• NRS

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

  Hour 4, Hour 24, Hour48 post-operatively

Secondary Outcomes (7)

• Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning

  during operation

• Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning

  during operation

• Measurement of analgesia relative brain regions assessed by T2-SPACE under fMRI scanning

  during operation

• systolic blood pressure (SBP)

  during operation

• diastolic blood pressure (DBP)

  during operation

Other Outcomes (1)

• PONV

  Day 7 postoperatively

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

1.5 µg kg-1 h-1 dexmedetomidine

Drug: Dexmedetomidine Injectable Solution

Placebo group

PLACEBO COMPARATOR

0.9% sodium chloride injection

Drug: Sodium Chloride 0.9% Inj

Interventions

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.

Also known as: Dexmedetomidine

Dexmedetomidine group

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.

Also known as: only opioid and Sodium Chloride as placebo administration

Placebo group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of epilepsy and eligible for radiofrequency ablation
• years old;
• American Society of Anesthesiologists rated (ASA) I-II
• body mass index (BMI)18.5\~27.9 kg·m2.

You may not qualify if:

• pre-existing neuropsychiatric disorders;
• emergency surgery;
• coma;
• depression;
• cognitive impairment;
• implanted with metal devices.

Sponsors & Collaborators

• China International Neuroscience Institution: lead

Study Sites (1)

Xuanwu hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Xinya Wang, Dr

  China International Neuroscience Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 15, 2022
• Study Start: January 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 20, 2024
• Last Updated: September 10, 2026

Record last verified: 2025-04

Locations

CN (1)