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Propofol Exclusivo versus Dexmedetomidina-Propofol em Crianças Submetidas a Ressonância Magnética

18 de setembro de 2026 atualizado por: Joseph Cravero, Boston Children's Hospital

Um Ensaio Randomizado de Variação de Dose de Propofol Apenas e Dexmedetomidina-Propofol em Crianças Submetidas a Ressonância Magnética

The most common imaging procedure requiring sedation/anesthesia for the pediatric population is magnetic resonance imaging (MRI). However, the optimal anesthetic/sedation plan has not been determined for these procedures. Historically, common medications have included the use of pentobarbital and propofol, but in 2015, publication in the New England Journal of Medicine highlighted the accumulating evidence for the possible neurotoxic effects of these types of anesthetics in animal models and a collection of epidemiologic studies in humans. Although these initial possibilities have since been proven as less of a concern, in the interim, data has shown that alternative sedative agents, such as dexmedetomidine, may not have the same neurotoxic effect and could possibly even provide neuroprotection. Dexmedetomidine also possesses other beneficial traits such as reducing risks of pulmonary atelectasis or upper airway collapse, typically found with the administration of propofol.

A concern raised by previous studies has been the possibility that the addition of dexmedetomidine could increase recovery times, leading to disruptions in workflow. Although it has been shown that large doses of dexmedetomidine exposure may lead to longer PACU stays, it is uncertain whether a small dose of dexmedetomidine would have such a significant impact. Based on the investigators' pilot trial6, the investigators found that a bolus of 1 mcg/kg dose of dexmedetomidine with a bolus of titrated propofol of 2-3 mg/kg and an infusion of propofol of 100 mcg/kg/min provided adequate sedation for successful scans, reduced propofol (infusion) exposure by 60%, and did not significantly increase recovery times.

Finally, there is a paucity in literature for studies examining a range of doses subsequently; often, a control group is compared to a single, self-selected dose of choice. Here, the investigators hope to provide a range of doses to minimize selection bias in our study design and determine the dose that would provide the optimal sedation for these scans and minimize excess anesthetic exposure.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

105

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

1 ano a 12 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Patients presenting as outpatients, scheduled to receive an anesthetic for MRI of brain, body (spine, chest, abdomen, and/or pelvis) and/or extremity (arm and/or leg).
  • Patients must be a candidate for the sedation technique described in this study with a natural airway. This decision will be made by a staff member of the Department of Anesthesiology.
  • Between 1 and 12 years of age.
  • ASA status I, II, or III

Exclusion Criteria:

  • Inpatient at BCH
  • Diagnosis of a difficult airway, severe obstructive sleep apnea that is not compatible with spontaneous ventilation in a supine position, or requires an oral airway.
  • Congenital heart disease or history of dysrhythmia.
  • Taking digoxin or beta-blocker
  • Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
  • History or a family (parent or sibling) history of malignant hyperthermia.
  • Allergy to or has a contraindication to propofol, lidocaine, or dexmedetomidine.
  • Tracheostomy or other mechanical airway device present
  • Received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).
  • Patient is not scheduled to receive anesthesia-sedation care or is noted to "try-without anesthesia" for the MRI
  • Patient has significant developmental or psychological delays
  • Patient scheduled for scan of duration <30 minutes or >90 minutes

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Propofol Only (P)

1 mg/kg (max 25 kg) of IV lidocaine (standard of care) will be given. 2-4 mg/kg titrated bolus of propofol will be administered, which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After that, 250 mcg/kg/min infusion of propofol will be initiated and can be titrated up to a maximum of 300 mcg/kg/min to maintain a Ramsay Sedation Score of 5-6. If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion. Per standard of care, the propofol infusion may be decreased if the blood pressure decreases by more than 30% from lowest expected norms or if there is any indication of possible airway obstruction.
Medicamento: Propofol (IV) 2-4 mg/kg

If patient is randomized to the P arm, patient will receive 2-4 mg/kg titrated, IV bolus of propofol until sleep is induced.

Outros nomes:
  • Diprivan
Medicamento: Propofol (IV) Infusion 250 mcg/kg/min

If the patient is randomized to the P arm, following the bolus of propofol, the patient will be started on an IV propofol infusion of 250 mcg/kg/min.

Outros nomes:
  • Diprivan
Comparador Ativo: Dexmedetomidine (high)-Propofol (DHP)

1 mcg/kg dexmedetomidine (DEX) bolus over 5-10 minutes will be delivered by fractionated doses or infusion. After the DEX bolus is complete, 1 mg/kg (max 25 mg) of IV lidocaine will be administered followed by a dose of 2-3 mg/kg titrated bolus of propofol (P), which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After this, 150 mcg/kg/min infusion of P will be initiated. If the Ramsay Sedation score of 5-6 is not achieved within 2 minutes, 1-2 mg/kg bolus of P may be administered and P infusion will be increased to 200 mcg/kg/min. The P infusion can be titrated up to a maximum of 300 mcg/kg/min if needed to maintain a Ramsay Sedation Score of 5-6. If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion. Per standard of care, the propofol infusion may be decreased if the blood pressure decreases by more than 30% from lowest expected norms or if there is any indication of possible airway obstruction.
Medicamento: Dexmedetomidine (IV) 1 mcg/kg

If patient is randomized to the DHP arm, patient will receive an IV bolus of 1 mcg/kg dexmedetomidine over 5 minutes.

Outros nomes:
  • Precedex
Medicamento: Propofol (IV) 1-2 mg/kg

If the patient is randomized to the DLP or DHP arm, following the dexmedetomidine bolus, the patient will receive a titrated, IV bolus of 1-2 mg/kg propofol.

Outros nomes:
  • Diprivan
Medicamento: Propofol (IV) Infusion 150 mcg/kg/min

If the patient is randomized to the DLP or DHP arm, following the titrated propofol bolus, the patient will be started on an IV propofol infusion of 150 mcg/kg/min.

Outros nomes:
  • Diprivan
Comparador Ativo: Dexmedetomidine (low)-Propofol (DLP)

0.5 mcg/kg dexmedetomidine (DEX) bolus over 5-10 minutes will be delivered by fractionated doses or infusion. After the DEX bolus is complete, 1 mg/kg (max 25 mg) of IV lidocaine will be administered followed by a dose of 2-3 mg/kg titrated bolus of propofol (P), which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After this, 150 mcg/kg/min infusion of P will be initiated. If the Ramsay Sedation score of 5-6 is not achieved within 2 minutes, 1-2 mg/kg bolus of P may be administered and P infusion will be increased to 200 mcg/kg/min. The P infusion can be titrated up to a maximum of 300 mcg/kg/min if needed to maintain a Ramsay Sedation Score of 5-6. If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion. Per standard of care, the propofol infusion may be decreased if the blood pressure decreases by more than 30% from lowest expected norms or if there is any indication of possible airway obstruction.
Medicamento: Propofol (IV) 1-2 mg/kg

If the patient is randomized to the DLP or DHP arm, following the dexmedetomidine bolus, the patient will receive a titrated, IV bolus of 1-2 mg/kg propofol.

Outros nomes:
  • Diprivan
Medicamento: Propofol (IV) Infusion 150 mcg/kg/min

If the patient is randomized to the DLP or DHP arm, following the titrated propofol bolus, the patient will be started on an IV propofol infusion of 150 mcg/kg/min.

Outros nomes:
  • Diprivan
Medicamento: Dexmedetomidine (IV) 0.5 mcg/kg

If patient is randomized to the DLP arm, patient will receive an IV bolus of 0.5 mcg/kg dexmedetomidine over 5 minutes.

Outros nomes:
  • Precedex

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Total Propofol (mcg/kg/min) consumption
Prazo: Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan

The total amount of propofol (mcg/kg/min) consumed will be measured for the duration of anesthesia time for the P, DLP, and DHP arms.
Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Peak Pediatric Anesthesia Emergence Delirium (PAED) Score
Prazo: Up to 180 minutes or duration of PACU stay

The peak (highest) PAED score will be obtained in the post-anesthesia recovery area (PACU).
Up to 180 minutes or duration of PACU stay
Incidence of Adverse Events
Prazo: Up to 240 minutes or from induction of anesthesia/sedation to immediately during recovery

Arterial desaturation, airway obstruction, hypotension and bradycardia
Up to 240 minutes or from induction of anesthesia/sedation to immediately during recovery
Incidences of Patient Movements/MRI Interruptions
Prazo: Up to 90 minutes or duration of MRI scan

If patient moved during their MRI and caused an interruption of the scan.
Up to 90 minutes or duration of MRI scan
Incidence of Technique Failure
Prazo: Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan

Lack of adequate sedation for MRI scan in spite of the sedation as described above (based on anesthesiologist's discretion or PSSS)
Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan
Case Duration
Prazo: Up to 90 minutes or duration of MRI scan

Total number of minutes in the MRI scanner
Up to 90 minutes or duration of MRI scan
Post Anesthesia Care Unit (PACU) Duration
Prazo: Up to 180 minutes or duration of PACU stay

Total number of minutes in the PACU
Up to 180 minutes or duration of PACU stay
Ramsay Sedation Score
Prazo: 10 minutes or from anesthesia induction to MRI scan start

Average Ramsay Sedation Score
10 minutes or from anesthesia induction to MRI scan start

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Boston Children's Hospital

Investigadores

  • Investigador principal: Joseph Cravero, MD, Boston Children's Hospital

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

30 de junho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

24 de janeiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de janeiro de 2026

Primeira postagem (Real)

27 de janeiro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de setembro de 2026

Última verificação

1 de janeiro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IRB-P00052391

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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