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Sedative

Dexmedetomidine (bolus only)-Propofol arm for Cerebral Palsy

Phase 4
Waitlist Available
Led By Joseph Cravero, MD
Research Sponsored by Joseph Cravero
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of the mri scan - approximately one hour
Awards & highlights

Study Summary

This trial is testing whether using dexmedetomidine can lower the amount of propofol needed for an MRI. There are two groups - one getting a dexmedetomidine infusion and one getting a dexmedetomidine bolus.

Eligible Conditions
  • Cerebral Palsy
  • Epilepsy
  • Developmental Delay

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from completion of the mri scan until prepared for discharge - approximately 90 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and from completion of the mri scan until prepared for discharge - approximately 90 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Case Times
Dosage/Consumption
Incidence of Adverse Events
+1 more
Secondary outcome measures
Case Duration
Incidence of Technique Failure
Recovery Time
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dexmedetomidine (bolus only)-Propofol armExperimental Treatment1 Intervention
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
Group II: Dexmedetomidine (bolus and low infusion)-Propofol armExperimental Treatment1 Intervention
Patients in this cohort will receive a combination of Dexmedetomidine 1mcg/kg bolus, Dexmedetomidine 0.5 mcg/kg/hour infusion, and Propofol 100mcg/kg/minute to accomplish an MRI examination.
Group III: Dexmedetomidine (bolus and high infusion)-Propofol armExperimental Treatment1 Intervention
Patients in this cohort will receive a combination of Dexmedetomidine 1mcg/kg bolus, Dexmedetomidine 1 mcg/kg/hour infusion, and Propofol 100mcg/kg/minute to accomplish an MRI examination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine bolus and high infusion-Propofol
2017
Completed Phase 4
~80
Dexmedetomidine bolus and low infusion-Propofol
2017
Completed Phase 4
~80
Dexmedetomidine bolus only - Propofol
2017
Completed Phase 4
~80

Find a Location

Who is running the clinical trial?

Joseph CraveroLead Sponsor
Joseph Cravero, MDPrincipal InvestigatorBoston Children's Hospital
2 Previous Clinical Trials
631 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Pediatric AnesthesiaJournal
Dexmedetomidine for Pediatric MRI Sedation: A Review of a Series of Cases
HEARD, CHRISTOPHER M.B., PRASHANT JOSHI, and KRISTIN JOHNSON. 2007. “Dexmedetomidine for Pediatric MRI Sedation: A Review of a Series of Cases”. Pediatric Anesthesia. Wiley. doi:10.1111/j.1460-9592.2007.02272.x.
Critical Care MedicineJournal
Bispectral Index-guided Sedation with Dexmedetomidine in Intensive Care: A Prospective, Randomized, Double Blind, Placebo-controlled Phase II Study*
Triltsch, Andreas E., Martin Welte, Peter von Homeyer, Jochen Groe, Arka Genähr, Maryam Moshirzadeh, Alexander Sidiropoulos, Wolfgang Konertz, Wolfgang J. Kox, and Claudia D. Spies. 2002. “Bispectral Index-guided Sedation with Dexmedetomidine in Intensive Care: A Prospective, Randomized, Double Blind, Placebo-controlled Phase II Study*”. Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00003246-200205000-00009.
New England Journal of MedicineJournal
Anesthetic Neurotoxicity — Clinical Implications of Animal Models
Rappaport, Bob A., Santhanam Suresh, Sharon Hertz, Alex S. Evers, and Beverley A. Orser. 2015. “Anesthetic Neurotoxicity — Clinical Implications of Animal Models”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmp1414786.
Pediatric AnesthesiaJournal
Comparison of Propofol and Dexmedetomedine Techniques in Children Undergoing Magnetic Resonance Imaging
Wu, Junzheng, Mohamed Mahmoud, Megan Schmitt, Md Hossain, and Dean Kurth. 2014. “Comparison of Propofol and Dexmedetomedine Techniques in Children Undergoing Magnetic Resonance Imaging”. Edited by Charles Cote. Pediatric Anesthesia. Wiley. doi:10.1111/pan.12408.
~9 spots leftby Apr 2025
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