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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-12
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine (IV) 0.5 mcg/kg

    Drug

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

  • Propofol (IV) 2-4 mg/kg

    Drug

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

  • Dexmedetomidine (IV) 1 mcg/kg

    Drug

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

  • Propofol (IV) 1-2 mg/kg

    Drug

    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.

  • Propofol (IV) Infusion 250 mcg/kg/min

    Drug

    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.

  • Propofol (IV) Infusion 150 mcg/kg/min

    Drug

    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.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Propofol Only (P)Active comparator 2 interventions
Group B: Dexmedetomidine (high)-Propofol (DHP)Active comparator 3 interventions
Group C: Dexmedetomidine (low)-Propofol (DLP)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Total Propofol (mcg/kg/min) consumption

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.

Time frame
Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan

Secondary outcomes

1

Peak Pediatric Anesthesia Emergence Delirium (PAED) Score

The peak (highest) PAED score will be obtained in the post-anesthesia recovery area (PACU).

Time frame
Up to 180 minutes or duration of PACU stay
2

Incidence of Adverse Events

Arterial desaturation, airway obstruction, hypotension and bradycardia

Time frame
Up to 240 minutes or from induction of anesthesia/sedation to immediately during recovery
3

Incidences of Patient Movements/MRI Interruptions

If patient moved during their MRI and caused an interruption of the scan.

Time frame
Up to 90 minutes or duration of MRI scan
4

Incidence of Technique Failure

Lack of adequate sedation for MRI scan in spite of the sedation as described above (based on anesthesiologist's discretion or PSSS)

Time frame
Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan

Other outcomes

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