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临床试验/NCT05619627
NCT05619627尚未招募1 期

Utility of Oral Dexmedetomidine as the Sole Sedative Agent in Pediatric Population Undergoing MRI

Soroush Merchant1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
18
试验地点
1
主要终点
Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI study

研究概览

简要总结

The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.

详细描述

MRI is an important and robust medical imaging technique that has become the cornerstone for radiologic studies. Superior image quality and resolution especially for soft tissue imaging, without the use of ionizing radiation, has made MRI a dominant imaging modality in pediatrics. Despite its many advantages, MRI is not child friendly. Lengthy scan times, the need for lying motionless in a confined space, excessive noise and vibration during image acquisition, are all factors that have made anesthesia an integral part of pediatric MRI.

General anesthesia is a state of medically induced unconsciousness, analgesia and muscle relaxation which is required for most invasive medical procedures. Despite being painless, MRI scans are highly susceptible to motion artifact and require a state of immobility that may not be obtainable in awake uncooperative children. While very safe, general anesthesia carries potential risk of serious morbidity and mortality secondary to aspiration during instrumentation of the airway, hypoxia and hypoventilation secondary to laryngospasm/bronchospasm and hemodynamic instability. Therefore, sedation may be an appropriate technique to offer anxiolysis, amnesia and immobility while maintaining airway reflexes with limited impact on ventilation and hemodynamics for non-stimulating procedures such as imaging. Aside from having a more favorable risk/benefit profile as compared to general anesthesia when it comes to radiologic studies, sedation is also less costly and burdensome on anesthesia departments and could provide immense cost-saving measures for healthcare institutions at large.

While there are many intravenous (IV) sedatives, establishing IV access while awake could be very traumatizing, leaving a lasting negative impression of the healthcare environment in a child's mind. Hence, enteral medications may be more acceptable and child friendly. This is especially valuable in patients who require repeated surveillance imaging and who demonstrate heightened level of anxiety and fear with each visit. Among sedative agents that could be administered enterally, dexmedetomidine may be superior due to minimal respiratory depression while providing anxiolysis and analgesia. Of note, dexmedetomidine is a highly selective alpha2-adrenoreceptor agonist that exerts its hypnotic action through activation of central pre- and postsynaptic alpha2-receptors in the locus coeruleus, mimicking natural sleep.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants 3-6 years old, male and female, all races and ethnicities
  • Requiring a clinically indicated MRI with general anesthesia

排除标准

  • Refusal to take oral dexmedetomidine
  • Known allergy to dexmedetomidine
  • Inability to take dexmedetomidine at least 90 minutes prior to start of the MRI
  • Medical contraindications to administration of dexmedetomidine including:
  • Unstable cardiac status including life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction
  • Current use of digoxin
  • Moya Moya disease
  • New onset stroke
  • American Society of Anesthesiologists (ASA) physical status classification > II
  • Contraindications to administering sedation including:
  • Active and uncontrolled gastroesophageal reflux
  • Active and uncontrolled vomiting
  • Current or recent history of apnea
  • Active respiratory disease including pneumonia, bronchitis, respiratory syncytial virus infection, asthma exacerbation
  • Craniofacial anomalies
  • Inability to have MRI scans
  • Non-English speaking volunteers

研究组 & 干预措施

Dexmedetomidine 6 mcg/kg

Experimental

Group Two: Subjects will receive oral dexmedetomidine 6 mcg/kg 2 hours prior to MRI

干预措施: Dexmedetomidine (Drug)

General anesthesia

Active Comparator

Control group: Subjects will receive general anesthesia for their MRI

干预措施: General Anesthesia (control group) (Drug)

Dexmedetomidine 12 mcg/kg

Experimental

Group Five: Subjects will receive oral dexmedetomidine 12 mcg/kg 2 hours prior to MRI

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine 10 mcg/kg

Experimental

Group Four: Subjects will receive oral dexmedetomidine 10 mcg/kg 2 hours prior to MRI

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine 8 mcg/kg

Experimental

Group Three: Subjects will receive oral dexmedetomidine 8 mcg/kg 2 hours prior to MRI

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine 4 mcg/kg

Experimental

Group One: Subjects will receive oral dexmedetomidine 4 mcg/kg 2 hours prior to MRI

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI study

时间窗: From date of the first enrollment until the end of assessment of data collected from the last participant, up to 70 weeks

The primary outcome is determining a dose of oral dexmedetomidine that will safely (adverse event (AE) below moderate risk, as designated by the World Society of Intravenous Anesthesia (SIVA) adverse sedation event reporting tool) provide adequate sedation to successfully complete an MRI. Images should have adequate quality and resolution to be interpretated and will be graded by an attending radiologist. Each MRI sequence will be graded 1-3. 1: no-mild motion artifact; 2: moderate motion artifact; 3: severe motion artifact (non-diagnostic).

次要结局

未报告次要终点

研究者

发起方
Soroush Merchant
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Soroush Merchant

Director of Medical Pain Service, Principal Investigator, Assistant Professor of Anesthesiology, MD, MS

Children's Mercy Hospital Kansas City

研究点 (1)

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