A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
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|ClinicalTrials.gov Identifier: NCT02633241|
Recruitment Status : Recruiting
First Posted : December 17, 2015
Results First Posted : August 28, 2019
Last Update Posted : January 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Cerebral Palsy Developmental Delay||Drug: Dexmedetomidine bolus and infusion-Propofol Drug: Dexmedetomidine bolus only - Propofol||Phase 4|
A recent publication in the New England Journal of Medicine highlighted the accumulating evidence for neurotoxic effects of anesthetics in animal models and a collection of epidemiologic studies in humans. Recent studies of anesthesia in fetal and neonatal primates are yielding more evidence of neurotoxicity associated with many common anesthesia and sedation techniques (e.g. propofol, etomidate, sevoflurane, desflurane and isoflurane). On the other hand, the data suggests that some alternative sedative agents, such as Dexmedetomidine, may not have the same neurotoxic effect.
Children routinely undergo sedation for MRI scanning with large doses of propofol and other sedatives. Many of these scans occur at young ages when these children may be at risk of neurological injury from sedative exposure. In addition, these scans do not involve any stimulation - which could be protective against neurodegeneration.
The investigators propose a pilot study to determine if a standard bolus dose and infusion of dexmedetomidine can significantly decrease the dose of propofol (infusion) required for accomplishing an MRI. Based on previous work with the combination of propofol with dexmedetomidine for other procedures, the investigators propose a standard dose of dexmedetomidine (1 mcg/kg bolus followed by an infusion at 0.5 mcg/kg/hour). The investigators will augment this sedation with propofol 2-3mg/kg titrated bolus followed by 100mcg/kg/min infusion which can also be titrated up or down to a maximum of 300mcg/kg/min to keep the blood pressure and heart rate within 30% of baseline levels.) This arm of the study was completed in January 2018 and results were posted on clinicaltrials.gov thereafter.
The investigators are now adding a second arm to this study (amendment submitted to the FDA August 2021) to examine the effectiveness of dexmedetomidine (single) bolus dose (with no infusion) followed by propofol infusion to accomplish MRI. Recruitment for this arm is currently open (started October 2021) and therefore no data is available to be reported on this arm of the study.
The investigators hypothesize that the use of low dose propofol with dexmedetomidine will be effective undergoing MRI while sparing exposure to the high dose of the sedative.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging|
|Actual Study Start Date :||March 2, 2017|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||January 1, 2023|
Dexmedetomidine (bolus and infusion)-Propofol arm
Patients in this cohort will receive a combination of Dexmedetomidine 1mcg/kg and Propofol100mcg/kg/minute to accomplish an MRI examination.
Drug: Dexmedetomidine bolus and infusion-Propofol
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5mcg/kg/hour. At the 5 minute point, propofol will be given (2-3mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine whether or not the child is in an adequate state to begin the MRI scan. If the sedative effect of the dexmedetomidine-propofol does not produce a sufficiently sedated state within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose of Dexmedetomidine will not be changed. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes, the outcome will be recorded as a technique failure and sedation will continue at the discretion of the anesthesiologist.
Other Name: Dexmedetomidine-Propofol
Dexmedetomidine (bolus only)-Propofol arm
Patients in this cohort will receive dexmedetomidine 1mcg/kg over 5 minutes and then propofol 2-3mg/kg titrated bolus followed by 100mcg/kg/min infusion to accomplish MRI
Drug: Dexmedetomidine bolus only - Propofol
First, the investigators will begin by administering dexmedetomidine 1mcg/kg over 5 minutes. When this is completed, they will administer propofol 2-3mg/kg titrated bolus followed by 100mcg/kg/min infusion which can also be titrated up or down to a maximum of 300mcg/kg/min to keep the blood pressure and heart rate within 30% of baseline levels.
Other Name: Dexmedetomidine-Propofol
- Dosage/Consumption [ Time Frame: Prior to beginning the MRI and throughout the MRI scan - approximately one hour. ]Dosage and consumption of dexmedetomidine
- Incidence of Patient Movement and MRI Interruption [ Time Frame: During the MRI scan, until completion, approximately one hour. ]If patient moved during their MRI and caused an interruption of the scan.
- Incidence of Adverse Events [ Time Frame: From the time the medication is initiated just (5 minutes) prior to the MRI scan and during the MRI scan and immediately during recovery - approximately one hour and twenty minutes in total. ]arterial desaturation, airway obstruction, hypotension and bradycardia
- Case Times [ Time Frame: Timeframe immediately before the MRI scan while sedation medication is administered - approximately 10 minutes ]Number of minutes from the start of sedation medication administration to the time the patient is adequately sedated for the MRI scan,
- Incidence of Technique Failure [ Time Frame: During the MRI scan until completion - approximately one hour ]lack of adequate sedation for MRI scan in spite of the sedation as described above
- Sedation Infusion Time [ Time Frame: For the duration of the MRI scan - approximately one hour ]The number of minutes that the patient was receiving dexmedetomidine infusion,
- Case Duration [ Time Frame: Duration of the MRI scan - approximately one hour ]total number of minutes in the MRI scanner,
- Recovery Time [ Time Frame: from completion of the MRI scan until prepared for discharge - approximately 90 minutes ]number of minutes in the recovery area until the patient appeared awake (eye opening),
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633241
|Contact: Jocelyn Booth, BSfirstname.lastname@example.org|
|Contact: Rachel Bernier, MPHemail@example.com|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Joseph Cravero, MD firstname.lastname@example.org|
|Principal Investigator:||Joseph Cravero, MD||Boston Children's Hospital|