Dexmedetomidine and Propofol for Pediatric MRI Sedation

NCT03513757 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: CHW 959242-5
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol). The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. The investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, the investigators will administer whatever is necessary. At the end of the study, the investigators will have an observer record the time it takes for participants to spontaneously open eyes , to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that the investigators find out from participants about changes in behavior, or if eating or sleeping habits were unusual following completion of the study. For that reason, the investigators will call participants in a day or so following the MRI scan. The investigators expect to recruit 40 children between the ages of 12 and 72 months for the study and hope to have the study completed in December 2018.

Conditions

Headache; Tumor; Seizure Disorder; Neurofibromatoses; Hydrocephalus; Abdominal Neoplasm; Spine Deformity

Outcome Measures

Primary Outcomes (1)

• Efficiency of Propofol Dexmedetomidine Sedation Compared With Propofol Infusion

  Time (minutes) from anesthesia start to readiness for discharge from the department to home or clinic.

  through study completion, an average of 2 hours

Secondary Outcomes (12)

• Total Propofol Administered

  up to 90 minutes

• Dexmedetomidine Dose

  up to 90 minutes

• Glycopyrrolate Dose

  5 minutes

• Lidocaine Dose

  up to 90 minutes

• Nitrous Oxide

  up to 10 minutes

Study Arms (2)

propofol

ACTIVE COMPARATOR

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

Drug: propofol; Drug: Lidocaine 1% Injectable Solution; Drug: Nitrous Oxide; Drug: Sevoflurane

propofol dexmedetomidine

EXPERIMENTAL

Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.

Drug: propofol; Drug: Dexmedetomidine; Drug: Glycopyrrolate; Drug: Lidocaine 1% Injectable Solution; Drug: Nitrous Oxide; Drug: Sevoflurane

Interventions

propofol DRUG

propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists

Also known as: diprivan

propofol; propofol dexmedetomidine

Dexmedetomidine DRUG

single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg

Also known as: precedex

propofol dexmedetomidine

Glycopyrrolate DRUG

4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group

Also known as: Robinul

propofol dexmedetomidine

Lidocaine 1% Injectable Solution DRUG

1 mg/kg intravenous administration prior to propofol administration

Also known as: Xylocaine 1%

propofol; propofol dexmedetomidine

Nitrous Oxide DRUG

Inhalation of nitrous oxide may be used for IV placement

propofol; propofol dexmedetomidine

Sevoflurane DRUG

Inhalation of sevoflurane may be used for IV placement

Also known as: Ultane

propofol; propofol dexmedetomidine

Eligibility Criteria

• Age: 12 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children scheduled for outpatient MRI scans with expected duration of scan between 30 minutes and 75 minutes.

You may not qualify if:

• Inpatient status, airway abnormalities, allergy to any study medications, eggs and soy, and mitochondrial disorders.
• All subjects with any cardiac disease or history of cardiac arrhythmias will be excluded.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (9)

• Andropoulos DB, Greene MF. Anesthesia and Developing Brains - Implications of the FDA Warning. N Engl J Med. 2017 Mar 9;376(10):905-907. doi: 10.1056/NEJMp1700196. Epub 2017 Feb 8. No abstract available.

  PMID: 28177852 BACKGROUND

• Vespasiano M, Finkelstein M, Kurachek S. Propofol sedation: intensivists' experience with 7304 cases in a children's hospital. Pediatrics. 2007 Dec;120(6):e1411-7. doi: 10.1542/peds.2007-0145.

  PMID: 18055659 BACKGROUND

• Emrath ET, Stockwell JA, McCracken CE, Simon HK, Kamat PP. Provision of deep procedural sedation by a pediatric sedation team at a freestanding imaging center. Pediatr Radiol. 2014 Aug;44(8):1020-5. doi: 10.1007/s00247-014-2942-z. Epub 2014 May 24.

  PMID: 24859263 BACKGROUND

• Mallory MD, Baxter AL, Kost SI; Pediatric Sedation Research Consortium. Propofol vs pentobarbital for sedation of children undergoing magnetic resonance imaging: results from the Pediatric Sedation Research Consortium. Paediatr Anaesth. 2009 Jun;19(6):601-11. doi: 10.1111/j.1460-9592.2009.03023.x.

  PMID: 19645979 BACKGROUND

• Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. Paediatr Anaesth. 2008 May;18(5):403-11. doi: 10.1111/j.1460-9592.2008.02468.x. Epub 2008 Mar 18.

  PMID: 18363626 BACKGROUND

• Siddappa R, Riggins J, Kariyanna S, Calkins P, Rotta AT. High-dose dexmedetomidine sedation for pediatric MRI. Paediatr Anaesth. 2011 Feb;21(2):153-8. doi: 10.1111/j.1460-9592.2010.03502.x.

  PMID: 21210884 BACKGROUND

• Akpinar H, Naziroglu M, Ovey IS, Cig B, Akpinar O. The neuroprotective action of dexmedetomidine on apoptosis, calcium entry and oxidative stress in cerebral ischemia-induced rats: Contribution of TRPM2 and TRPV1 channels. Sci Rep. 2016 Nov 22;6:37196. doi: 10.1038/srep37196.

  PMID: 27872485 BACKGROUND

• Boriosi JP, Eickhoff JC, Klein KB, Hollman GA. A retrospective comparison of propofol alone to propofol in combination with dexmedetomidine for pediatric 3T MRI sedation. Paediatr Anaesth. 2017 Jan;27(1):52-59. doi: 10.1111/pan.13041. Epub 2016 Oct 25.

  PMID: 27779360 BACKGROUND

• Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.

  PMID: 15114210 BACKGROUND

MeSH Terms

Conditions

Headache; Neoplasms; Epilepsy; Neurofibromatoses; Hydrocephalus; Abdominal Neoplasms

Interventions

Propofol; Dexmedetomidine; Glycopyrrolate; Lidocaine; Nitrous Oxide; Sevoflurane

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quaternary Ammonium Compounds; Amines; Onium Compounds; Pyrrolidines; Acetanilides; Anilides; Amides; Aniline Compounds; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Susan Taylor MD
• Organization: Medical College of Wisconsin

sutaylor@mcw.edu

414-266-3560

Study Officials

• Susan P Taylor, MD, MPH

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients and their parents/guardians as well as the blinded observer or investigator who participates in outcomes assessment will be blinded to the drug or drugs administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatric Anesthesiology

Model Details: observer blinded comparison of propofol with low-dose propofol and dexmedetomidine for pediatric MRI sedation

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: May 2, 2018
• Study Start: March 4, 2018
• Primary Completion: August 21, 2018
• Study Completion: October 21, 2018
• Last Updated: February 21, 2020
• Results First Posted: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)