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

Primary Purpose

Epilepsy, Cerebral Palsy, Developmental Delay

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dexmedetomidine bolus and high infusion-Propofol

Dexmedetomidine bolus and low infusion-Propofol

Dexmedetomidine bolus only - Propofol

About this trial

This is an interventional health services research trial for Epilepsy focused on measuring pediatrics, sedation, dexmedetomidine, propofol, MRI

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
The subject must be a candidate for the sedation technique described in this study with a natural airway (see exclusion criteria described below). This decision will be made by a staff member of the Department of Anesthesiology.
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

Exclusion Criteria:

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.

Sites / Locations

Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Dexmedetomidine (bolus and high infusion)-Propofol arm

Dexmedetomidine (bolus and low infusion)-Propofol arm

Dexmedetomidine (bolus only)-Propofol arm

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Dosage/Consumption

Dosage and consumption of dexmedetomidine infusion

Incidence of Patient Movement and MRI Interruption

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

Incidence of Adverse Events

arterial desaturation, airway obstruction, hypotension and bradycardia

Case Times

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

Secondary Outcome Measures

Incidence of Technique Failure

lack of adequate sedation for MRI scan in spite of the sedation as described above

Sedation Infusion Time

The number of minutes that the patient was receiving dexmedetomidine infusion

Case Duration

total number of minutes in the MRI scanner,

Recovery Time

number of minutes in the recovery area until the patient appeared awake (eye opening),

Full Information

NCT ID

NCT02633241

First Posted

December 11, 2015

Last Updated

June 23, 2023

Sponsor

Joseph Cravero

1. Study Identification

Unique Protocol Identification Number

NCT02633241

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

March 2, 2017 (Actual)

Primary Completion Date

September 6, 2022 (Actual)

Study Completion Date

September 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Joseph Cravero

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

A recent publication in the New England Journal of Medicine highlighted the accumulating evidence for neurotoxic effects of anesthetics in animal models and a collection of epidemiologic studies in humans. Recent studies of anesthesia in fetal and neonatal primates are yielding more evidence of neurotoxicity associated with many common anesthesia and sedation techniques (e.g. propofol, etomidate, sevoflurane, desflurane and isoflurane). On the other hand, the data suggests that some alternative sedative agents, such as Dexmedetomidine, may not have the same neurotoxic effect. Children routinely undergo sedation for MRI scanning with large doses of propofol and other sedatives. Many of these scans occur at young ages when these children may be at risk of neurological injury from sedative exposure. In addition, these scans do not involve any stimulation - which could be protective against neurodegeneration. The investigators propose 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. Based on previous work with the combination of propofol with dexmedetomidine for other procedures, the investigators propose a standard dose of dexmedetomidine (1 mcg/kg bolus followed by an infusion at 1.0 mcg/kg/hour, 0.5 mcg/kg/hour, or no infusion). The investigators will augment this sedation with propofol 2-3 mg/kg titrated bolus followed by 100 mcg/kg/min infusion which can also be titrated up or down to a maximum of 300 mcg/kg/min to keep the blood pressure and heart rate within 30% of baseline levels). The investigators hypothesize that the use of low dose propofol with dexmedetomidine will be effective undergoing MRI while sparing exposure to the high dose of the sedative.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Cerebral Palsy, Developmental Delay

Keywords

pediatrics, sedation, dexmedetomidine, propofol, MRI

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine (bolus and high infusion)-Propofol arm

Arm Type

Other

Arm Description

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.

Arm Title

Dexmedetomidine (bolus and low infusion)-Propofol arm

Arm Type

Other

Arm Description

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.

Arm Title

Dexmedetomidine (bolus only)-Propofol arm

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine bolus and high infusion-Propofol

Other Intervention Name(s)

Dexmedetomidine-Propofol

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine bolus and low infusion-Propofol

Other Intervention Name(s)

Dexmedetomidine-Propofol

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine bolus only - Propofol

Other Intervention Name(s)

Dexmedetomidine-Propofol

Intervention Description

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.

Primary Outcome Measure Information:

Title

Dosage/Consumption

Description

Dosage and consumption of dexmedetomidine infusion

Time Frame

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

Title

Incidence of Patient Movement and MRI Interruption

Description

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

Time Frame

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

Title

Incidence of Adverse Events

Description

arterial desaturation, airway obstruction, hypotension and bradycardia

Time Frame

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.

Title

Case Times

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Incidence of Technique Failure

Description

lack of adequate sedation for MRI scan in spite of the sedation as described above

Time Frame

During the MRI scan until completion - approximately one hour

Title

Sedation Infusion Time

Description

The number of minutes that the patient was receiving dexmedetomidine infusion

Time Frame

For the duration of the MRI scan - approximately one hour

Title

Case Duration

Description

total number of minutes in the MRI scanner,

Time Frame

Duration of the MRI scan - approximately one hour

Title

Recovery Time

Description

number of minutes in the recovery area until the patient appeared awake (eye opening),

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). The subject must be a candidate for the sedation technique described in this study with a natural airway (see exclusion criteria described below). This decision will be made by a staff member of the Department of Anesthesiology. 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Cravero, MD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Children's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25714157

Citation

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.

Results Reference

background

PubMed Identifier

24814202

Citation

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.

Results Reference

background

PubMed Identifier

17683409

Citation

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.

Results Reference

background

PubMed Identifier

12006795

Citation

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.

Results Reference

background

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

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