[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621323":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":61,"centralContacts":65,"locations":76,"responsibleParty":93,"collaborators":70,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":70,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":70,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":120,"overallStatus":78,"whyStopped":70,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,15,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Propofol Only (P)","ACTIVE_COMPARATOR","1 mg\u002Fkg (max 25 kg) of IV lidocaine (standard of care) will be given. 2-4 mg\u002Fkg 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\u002Fkg\u002Fmin infusion of propofol will be initiated and can be titrated up to a maximum of 300 mcg\u002Fkg\u002Fmin 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.",[13,14],"Drug: Propofol (IV) 2-4 mg\u002Fkg","Drug: Propofol (IV) Infusion 250 mcg\u002Fkg\u002Fmin",{"label":16,"type":10,"description":17,"interventionNames":18},"Dexmedetomidine (high)-Propofol (DHP)","1 mcg\u002Fkg dexmedetomidine (DEX) bolus over 5-10 minutes will be delivered by fractionated doses or infusion. After the DEX bolus is complete, 1 mg\u002Fkg (max 25 mg) of IV lidocaine will be administered followed by a dose of 2-3 mg\u002Fkg titrated bolus of propofol (P), which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After this, 150 mcg\u002Fkg\u002Fmin infusion of P will be initiated. If the Ramsay Sedation score of 5-6 is not achieved within 2 minutes, 1-2 mg\u002Fkg bolus of P may be administered and P infusion will be increased to 200 mcg\u002Fkg\u002Fmin. The P infusion can be titrated up to a maximum of 300 mcg\u002Fkg\u002Fmin 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.",[19,20,21],"Drug: Dexmedetomidine (IV) 1 mcg\u002Fkg","Drug: Propofol (IV) 1-2 mg\u002Fkg","Drug: Propofol (IV) Infusion 150 mcg\u002Fkg\u002Fmin",{"label":23,"type":10,"description":24,"interventionNames":25},"Dexmedetomidine (low)-Propofol (DLP)","0.5 mcg\u002Fkg dexmedetomidine (DEX) bolus over 5-10 minutes will be delivered by fractionated doses or infusion. After the DEX bolus is complete, 1 mg\u002Fkg (max 25 mg) of IV lidocaine will be administered followed by a dose of 2-3 mg\u002Fkg titrated bolus of propofol (P), which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After this, 150 mcg\u002Fkg\u002Fmin infusion of P will be initiated. If the Ramsay Sedation score of 5-6 is not achieved within 2 minutes, 1-2 mg\u002Fkg bolus of P may be administered and P infusion will be increased to 200 mcg\u002Fkg\u002Fmin. The P infusion can be titrated up to a maximum of 300 mcg\u002Fkg\u002Fmin 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.",[26,20,21],"Drug: Dexmedetomidine (IV) 0.5 mcg\u002Fkg",[28,35,41,46,51,56],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Dexmedetomidine (IV) 0.5 mcg\u002Fkg","If patient is randomized to the DLP arm, patient will receive an IV bolus of 0.5 mcg\u002Fkg dexmedetomidine over 5 minutes.",[23],[34],"Precedex",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Propofol (IV) 2-4 mg\u002Fkg","If patient is randomized to the P arm, patient will receive 2-4 mg\u002Fkg titrated, IV bolus of propofol until sleep is induced.",[9],[40],"Diprivan",{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Dexmedetomidine (IV) 1 mcg\u002Fkg","If patient is randomized to the DHP arm, patient will receive an IV bolus of 1 mcg\u002Fkg dexmedetomidine over 5 minutes.",[16],[34],{"type":29,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Propofol (IV) 1-2 mg\u002Fkg","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\u002Fkg propofol.",[16,23],[40],{"type":29,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Propofol (IV) Infusion 250 mcg\u002Fkg\u002Fmin","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\u002Fkg\u002Fmin.",[9],[40],{"type":29,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Propofol (IV) Infusion 150 mcg\u002Fkg\u002Fmin","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\u002Fkg\u002Fmin.",[16,23],[40],[62],{"name":63,"affiliation":5,"role":64},"Joseph Cravero, MD","PRINCIPAL_INVESTIGATOR",[66,72],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},"Samuel Kim, BS","CONTACT","617-919-3692",null,"samuel.kim@childrens.harvard.edu",{"name":73,"role":68,"phone":74,"phoneExt":70,"email":75},"Rachel Bernier, MPH","857-218-5348","rachel.bernier@childrens.harvard.edu",[77],{"facility":5,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-71.05977,42.35843,{"lat":88,"lon":87},[91],{"name":63,"role":68,"phone":70,"phoneExt":70,"email":92},"joseph.cravero@childrens.harvard.edu",{"type":64,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":70,"oldOrganization":70},"Joseph Cravero","MD, Anesthesia, Critical Care and Pain Medicine, Principal Investigator","100621323","phase-4-propofol-only-versus-dexmedetomidine-propofol-in-children-undergoing-magnetic-resonance-imaging-100621323",false,"NCT07369128","Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging","A Randomized, Dose-Ranging Trial of Propofol-Only and Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging","Inclusion Criteria:\n\n* Patients presenting as outpatients, scheduled to receive an anesthetic for MRI of brain, body (spine, chest, abdomen, and\u002For pelvis) and\u002For extremity (arm and\u002For leg).\n* 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.\n* Between 1 and 12 years of age.\n* ASA status I, II, or III\n\nExclusion Criteria:\n\n* Inpatient at BCH\n* 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.\n* Congenital heart disease or history of dysrhythmia.\n* Taking digoxin or beta-blocker\n* Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).\n* History or a family (parent or sibling) history of malignant hyperthermia.\n* Allergy to or has a contraindication to propofol, lidocaine, or dexmedetomidine.\n* Tracheostomy or other mechanical airway device present\n* Received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).\n* Patient is not scheduled to receive anesthesia-sedation care or is noted to \"try-without anesthesia\" for the MRI\n* Patient has significant developmental or psychological delays\n* Patient scheduled for scan of duration \\\u003C30 minutes or \\>90 minutes","ALL","1 Year","12 Years",{"count":107,"type":108},105,"ESTIMATED","INTERVENTIONAL",[111],"PHASE4","The most common imaging procedure requiring sedation\u002Fanesthesia for the pediatric population is magnetic resonance imaging (MRI). However, the optimal anesthetic\u002Fsedation 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.\n\nA 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\u002Fkg dose of dexmedetomidine with a bolus of titrated propofol of 2-3 mg\u002Fkg and an infusion of propofol of 100 mcg\u002Fkg\u002Fmin provided adequate sedation for successful scans, reduced propofol (infusion) exposure by 60%, and did not significantly increase recovery times.\n\nFinally, 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.",[114,115,116,117,118,119],"MRI Sedation","Pediatric Sedation","Propofol Dosage","Emergence Delirium, Anesthesia","Recovery Time","Dexmedetomidine",[121,122,123,124,125],"pediatrics","sedation","dexmedetomidine","propofol","MRI","2026-05-27",{"date":128,"type":129},"2026-05-29","ACTUAL",{"date":131,"type":108},"2026-06",{"date":133,"type":108},"2028-03",{"name":5,"class":6},1]