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Propofol-Alene versus Dexmedetomidin-Propofol hos barn som gjennomgår magnetresonanstomografi

18. september 2026 oppdatert av: Joseph Cravero, Boston Children's Hospital

En randomisert, doseringsbasert studie med kun propofol og dexmedetomidin-propofol hos barn som gjennomgår magnetresonanstomografi

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

105

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 år til 12 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Legemiddel: 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.

Andre navn:
  • Diprivan
Legemiddel: 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.

Andre navn:
  • Diprivan
Aktiv komparator: 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.
Legemiddel: 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.

Andre navn:
  • Precedex
Legemiddel: 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.

Andre navn:
  • Diprivan
Legemiddel: 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.

Andre navn:
  • Diprivan
Aktiv komparator: 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.
Legemiddel: 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.

Andre navn:
  • Diprivan
Legemiddel: 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.

Andre navn:
  • Diprivan
Legemiddel: 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.

Andre navn:
  • Precedex

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Propofol (mcg/kg/min) consumption
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peak Pediatric Anesthesia Emergence Delirium (PAED) Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 10 minutes or from anesthesia induction to MRI scan start

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boston Children's Hospital

Etterforskere

  • Hovedetterforsker: Joseph Cravero, MD, Boston Children's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. juni 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

24. januar 2026

Først innsendt som oppfylte QC-kriteriene

26. januar 2026

Først lagt ut (Faktiske)

27. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. september 2026

Sist bekreftet

1. januar 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB-P00052391

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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