Intra-nasal Dexmedetomidine for Children Undergoing MRI Imaging

MRI Sedation Clinical Trial

— DexmedMRI  

Official title:

Intra-nasal Dexmedetomidine for Children Undergoing MRI Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03806777
• Other study ID #: H18-02794
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 2019
• Est. completion date: October 2020

Study information

• Verified date: January 2019
• Source: University of British Columbia
• Contact: Andrew K Poznikoff, BSc
• Phone: 604-875-2000
• Email: andrew.poznikoff[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the use of intranasal dexmedetomidine (IN-dex) as a sole agent in aiding the successful completion of a MRI scans in children. Dexmedetomidine, a routinely used anesthetic agent in our institution, has many benefits including sedation with neuro-protective and respiratory sparing features. We will test its effectiveness in completing MRI scans in children that would otherwise be given a full general anesthetic.

Description:

Purpose:

To assess the use of IN-dex as a sole agent in aiding the successful completion of a MRI scan in children.

Hypothesis:

We hypothesize that the optimal dose for IN-dex to produce appropriate sedation for MRI will be between 1 and 3 mcg/kg. We also hypothesize that this dose will be lower in the older age group.

Justification:

The dose required for IN-dex to enable safe sedation for MRI scanning as a sole agent is undetermined at present. This study will enable us to find the optimal dose for effective sedation for MRI scanning in a range of age groups. This will avoid the need for propofol and remifentanil general anesthesia (that is the current standard of care) in this group of patients. Our motivation for avoiding general anesthesia is that there is ongoing concern that general anesthesia causes long term neurocognitive effects in children. Finally, identifying a safe yet effective dose of IN-dex, which can be nurse-administered, will also allow us to improve access to MRI scans that are limited by the access to general anesthesia.

Objectives:

1. To determine the dose of IN-dex that, when used as a sole agent, produces minimal to moderate sedation that is adequate for successful completion of MRI in children with >90% effectiveness.

2. To explore the logistics of a nurse-administered sedation protocol to increase access to the MRI.

Research Design:

We propose a dose finding study of IN-dex using the biased coin design (BCD) method in three different age groups (3 to <8 years, 8 to <12 years, 12 to <19 years). The study specific interventions will include identification of children appropriate for the study following detailed assessment using a scoring system developed by our Child Life specialists for use at their MRI preparation session.

Statistical Analysis:

The dose of IN-Dex that produces mild to moderate sedation in 90% of subjects will be calculated using the pooled adjacent violators algorithm (PAVA) and bootstrap methods will be used to calculate the 95% confidence limits.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: October 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• ASA 1 or 2

• Scheduled for elective MRI scan on the general anesthesia list

• Child Life MRI simulation score of 6-10 (Figure 1)

• Age 3 - 18

Exclusion Criteria:

• Taking existing opioid, sedative, or cannabinoid medication

• Severe learning disability defined as the inability to follow simple commands

• Severe Cardiac disease

• Chronic hypertension

• Allergy to dexmedetomidine

• Nasal anatomical abnormality

• Known or anticipated difficult airway

Related Conditions & MeSH terms

• MRI Sedation

Intervention

Drug:
• Dexmedetomidine
Highly selective alpha-2 adrenergic agonist with sedative properties.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose	The intranasal dexmedetomidine dose in mcg/kg that produces successful completion of MRI scan with acceptable MRI image quality in 90% of individuals (ED 90).	Immediately after completion of the MRI scan.
Secondary	Uninterrupted scans	Total number of scans that were able to be completed without interruptions	Immediately after completion of the MRI scan.
Secondary	Respirator support	Total number of occurrences of respiratory support	During MRI scan
Secondary	Adverse events	Occurrence of haemodynamic disturbance (bradycardia: absolute heart rate = 40 bpm, hypertension: relative mean arterial pressure = 50% baseline, hypotension: relative mean arterial pressure = 50% baseline)	During MRI scan
Secondary	modified Yale Preoperative Anxiety Scale (mYPAS)	Pre-procedure mYPAS score. The scale is a total summed score (4-22) of 5 areas; Activity (1-4), Vocalizations (1-6), Emotional expressivity (1-4), state of apparent arousal (1-4), and use of parents (1-4). A lower score represents a lower level of anxiety.	Immediately before administration of intranasal dexmedetomidine

External Links

•   Pediatric Anesthesia Research Team website