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Résztvevőt keres itt: Egyesült Államok4. fázis

Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging

A legfontosabb adatok

Ki végzi
Boston Children's Hospital
Hol
Boston (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Fázis
4. fázis
Résztvevők
105 fő, tervezett
Kezdés
2026. jún. 30.
Várható befejezés
2028. márc.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Dexmedetomidine (IV) 0.5 mcg/kg
  • Propofol (IV) 2-4 mg/kg
  • Dexmedetomidine (IV) 1 mcg/kg
  • Propofol (IV) 1-2 mg/kg
  • Propofol (IV) Infusion 250 mcg/kg/min
  • Propofol (IV) Infusion 150 mcg/kg/min
A regiszteradat frissítve
2026. szeptember 21.

Ki vehet részt

Életkor
1 év – 12 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 16 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine)
  • Received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol)
  • Congenital heart disease or history of dysrhythmia
  • History or a family (parent or sibling) history of malignant hyperthermia
  • Allergy to or has a contraindication to propofol, lidocaine, or dexmedetomidine
  • 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
  • Taking digoxin or beta-blocker
  • Tracheostomy or other mechanical airway device present
  • 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

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 1 és 12 év között vagy?

Helyszínek itt: Egyesült Államok

  • Boston Children's HospitalBoston, Egyesült ÁllamokContact: Joseph Cravero, MDRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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 teljes eredeti leírásKevesebb

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.

A vizsgálat 3 csoportja

  • Propofol Only (P)Már használt kezelés, összehasonlításként

    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.

    Kezelés: Propofol (IV) 2-4 mg/kg és Propofol (IV) Infusion 250 mcg/kg/min

  • Dexmedetomidine (high)-Propofol (DHP)Már használt kezelés, összehasonlításként

    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.

    Kezelés: Dexmedetomidine (IV) 1 mcg/kg, Propofol (IV) 1-2 mg/kg és Propofol (IV) Infusion 150 mcg/kg/min

  • Dexmedetomidine (low)-Propofol (DLP)Már használt kezelés, összehasonlításként

    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.

    Kezelés: Dexmedetomidine (IV) 0.5 mcg/kg, Propofol (IV) 1-2 mg/kg és Propofol (IV) Infusion 150 mcg/kg/min

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Randomized, Dose-Ranging Trial of Propofol-Only and Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
Illeszkedési kérdések
Forrás: NCT07369128: ki vehet részt
A regiszteradat frissítve
2026. szeptember 21.