A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging

NCT02633241 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB-P00019084
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This is 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. The investigators studied three arms to examine the effectiveness of dexmedetomidine. Arm 1 was a single bolus of 1.0 mcg/kg with 1.0 mcg/kg/hr infusion followed by propofol infusion. Arm 2 was a bolus of 1.0 mcg/kg with 0.5 mcg/kg/hr infusion followed by propofol infusion. Arm 3 was only a single bolus of 1.0 mcg/kg with no infusion followed by propofol infusion.

Conditions

Epilepsy; Cerebral Palsy; Developmental Delay

Keywords

pediatrics; sedation; dexmedetomidine; propofol; MRI

Outcome Measures

Primary Outcomes (4)

• Dosage/Consumption

  Dosage and consumption of dexmedetomidine infusion

  Prior to beginning the MRI and throughout the MRI scan - approximately one hour.

• Incidence of Patient Movement and MRI Interruption

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

  During the MRI scan, until completion, approximately one hour.

• Incidence of Adverse Events

  arterial desaturation, airway obstruction, hypotension and bradycardia

  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.

• Case Times

  Number of minutes from the start of sedation medication administration to the time the patient is adequately sedated for the MRI scan,

  Timeframe immediately before the MRI scan while sedation medication is administered - approximately 10 minutes

Secondary Outcomes (4)

• Incidence of Technique Failure

  During the MRI scan until completion - approximately one hour

• Sedation Infusion Time

  For the duration of the MRI scan - approximately one hour

• Case Duration

  Duration of the MRI scan - approximately one hour

• Recovery Time

  from completion of the MRI scan until prepared for discharge - approximately 90 minutes

Study Arms (3)

Dexmedetomidine (bolus and high infusion)-Propofol arm

OTHER

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.

Drug: Dexmedetomidine bolus and high infusion-Propofol

Dexmedetomidine (bolus and low infusion)-Propofol arm

OTHER

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.

Drug: Dexmedetomidine bolus and low infusion-Propofol

Dexmedetomidine (bolus only)-Propofol arm

OTHER

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

Interventions

Dexmedetomidine bolus and high infusion-Propofol DRUG

First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 1mcg/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.

Also known as: Dexmedetomidine-Propofol

Dexmedetomidine (bolus and high infusion)-Propofol arm

Dexmedetomidine bolus and low infusion-Propofol DRUG

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.

Also known as: Dexmedetomidine-Propofol

Dexmedetomidine (bolus and low infusion)-Propofol arm

Dexmedetomidine bolus only - Propofol DRUG

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.

Also known as: Dexmedetomidine-Propofol

Dexmedetomidine (bolus only)-Propofol arm

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects presenting as out-patients, scheduled to receive an anesthetic for MRI of body (spine, chest, abdomen, and/or pelvis) and/or extremity (arm and/or leg).

You may not qualify if:

• The subjects must be 1 and 12 years.
• The subject's legally authorized representative has given written informed consent to participate in the study.
• American Society of Anesthesiologist status I, II, or III
• The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.
• Diagnosis of a difficult airway or severe obstructive sleep apnea that is not compatible with spontaneous ventilation in a supine position.
• Congenital heart disease or history of dysrhythmia.
• Patient taking digoxin or beta-blocker
• Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
• The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
• The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
• The subject has previously been treated under this protocol.
• The subject has a tracheostomy or other mechanical airway device.
• The subject has received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).
• The subject is not scheduled to receive anesthesia-sedation care for the MRI.
• The subject received one of the anesthetic regimens for the same MRI during the past six months.

Sponsors & Collaborators

• Joseph Cravero: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• Rappaport BA, Suresh S, Hertz S, Evers AS, Orser BA. Anesthetic neurotoxicity--clinical implications of animal models. N Engl J Med. 2015 Feb 26;372(9):796-7. doi: 10.1056/NEJMp1414786.

  PMID: 25714157 BACKGROUND

• Wu J, Mahmoud M, Schmitt M, Hossain M, Kurth D. Comparison of propofol and dexmedetomedine techniques in children undergoing magnetic resonance imaging. Paediatr Anaesth. 2014 Aug;24(8):813-8. doi: 10.1111/pan.12408. Epub 2014 May 12.

  PMID: 24814202 BACKGROUND

• Heard CM, Joshi P, Johnson K. Dexmedetomidine for pediatric MRI sedation: a review of a series of cases. Paediatr Anaesth. 2007 Sep;17(9):888-92. doi: 10.1111/j.1460-9592.2007.02272.x.

  PMID: 17683409 BACKGROUND

• Triltsch AE, Welte M, von Homeyer P, Grosse J, Genahr A, Moshirzadeh M, Sidiropoulos A, Konertz W, Kox WJ, Spies CD. Bispectral index-guided sedation with dexmedetomidine in intensive care: a prospective, randomized, double blind, placebo-controlled phase II study. Crit Care Med. 2002 May;30(5):1007-14. doi: 10.1097/00003246-200205000-00009.

  PMID: 12006795 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Cerebral Palsy; Learning Disabilities

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Joseph P. Cravero
• Organization: Boston Children's Hospital

Joseph.Cravero@childrens.harvard.edu

617-355-4292

Study Officials

• Joseph Cravero, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 17, 2015
• Study Start: March 2, 2017
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: June 27, 2023
• Results First Posted: August 28, 2019

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)