Comparing Safety and Efficacy of Dexmedetomidine and Propofol

NCT01152021 | Terminated Phase 3 Results DMC

• 1 other identifier: 09-05-0250
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open label randomized study. The purpose of this study is to compare propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically identifying important patient demographics and looking at important outcomes including adverse events.

Conditions

Safety and Efficacy of Sedation Medications

Keywords

dexmedetomidine; propofol; sedation; MRI; scanning; pediatric; children; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events During the Sedation and Recovery Period

  Adverse events will be described by type, system involvement and level of severity.

  During sedation, recovery period and overnight, up to 24 hours

Secondary Outcomes (1)

• Clinical Parameters (Sedation Scales, Hemodynamic Variables, Clinical Observations)

  During sedation, recovery and overnight, up to 24 hours

Study Arms (2)

Dexmedetomidine Group

ACTIVE COMPARATOR

Dexmedetomidine given as 2mcg/kg bolus over 10 minutes followed by 1.5mcg/kg/hr infusion for duration of scan. The bolus may be repeated up to 2 times at any time during the sedation in the event that adequate sedation conditions (minimum Ramsay Sedation Score of 4) are not achieved. In the event that dexmedetomidine is unable to achieve motionless conditions, after a total of 3 boluses, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg, per established protocol.

Drug: Dexmedetomidine

Propofol Group

ACTIVE COMPARATOR

Propofol bolus at an initial dose of 1 mg/kg over 1 minute then up to two additional 1 mg/kg boluses may be administered (total 3 mg/kg) - each over a one (1) minute interval, waiting 30 seconds after completion of each bolus to reassess sedation level. Once a minimum Ramsey Sedation Score 4 is achieved, an infusion at 125 mcg/kg/min is initiated. It may be titrated to 300 mcg/kg/min. If there is movement or awakening the patient may be rebolused with no more than 2 doses of Propofol at 1 mg/kg over 1 minute, in the same dosing manner as described above, waiting 30 seconds between doses. If adequate sedation is not achieved, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg.

Drug: Propofol

Interventions

Dexmedetomidine DRUG

An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete.

Also known as: Precedex

Dexmedetomidine Group

Propofol DRUG

An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete.

Also known as: Diprivan

Propofol Group

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient is 3 - 11 years
• Patient is scheduled for MRI at Children's Hospital Boston.
• Patient meets criteria to receive either dexmedetomidine or propofol sedation
• Patient's guardian provides written consent

You may not qualify if:

• Patient does not meet established sedation criteria
• Patient has history of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity
• Patient has current, repaired, or risk for Moya-Moya disease
• Patient has had a stroke within the past six months
• Patient has uncontrolled hypertension
• Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker
• Known soy, Lecithin, or egg allergy

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

The study was terminated (halted prematurely) due to publication of a similar study and it was deemed unethical to continue.

Results Point of Contact

• Title: Rachel Dabek
• Organization: Department of Anesthesia, Perioperative and Pain Medicine

rachel.dabek@childrens.harvard.edu

857-218-5413

Study Officials

• Randy Prescilla, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Perioperative Anesthesia

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: August 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 21, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-05

Locations

US (1)