RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies

Study Overview
=================
Brief Summary
-----------------
RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies

Detailed Description
-----------------
A study comparing the dose of propofol used as a continuous infusion versus intermittent bolus dosing looking at recovery time complications, and quality of the MRI studies in Pediatric Sedation Services for patients age 1 month to 18 years receiving an brain or spine MRI.

Official Title
-----------------
RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies

Conditions
-----------------
Encephalopathy, Developmental Delay and Behavioral Changes, Cord Tumor Compression or Instability, Cord Tethering or Malformation

Intervention / Treatment
-----------------
* Procedure: Intermittent Propofol Sedation
* Procedure: Continuous Propofol Sedation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1 month to 18 years Receiving a brain or spine MRI with propofol sedation Deemed safe to undergo sedation with propofol based on a pre-sedation examination Patient judged not to require any pre-medication with any other medication except nasal decongestants or anticholinergic medications Exclusion Criteria: Patient below or above set age limits. Patient requires MRI studies on other body areas. Patient requires pre-medication with a sedative or tranquilizer Patient requires additional medications during sedation to complete the procedure. Propofol is being used as a rescue sedative to complete the procedure. Propofol is being used as a rescue sedative to complete a procedure that was initiated by another sedative. Patients who develop complications that require termination of the imaging procedure will not be included in the dose or recovery time calculations, but the complication will be counted as such in their respective group and study will be reported as non-diagnostic. Insulin dependent diabetes Thyroid disease

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dose Comparison<br>continuous versus intermittent bolus dosing | Procedure: Intermittent Propofol Sedation<br>* Intermittent versus continuous dosage<br>Procedure: Continuous Propofol Sedation<br>* intermittent vs continuous dosage<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing |  | study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedation, MRI, pediatric, propofol, brain, spine, quality of MRI, Continuous propofol dosing, continuous propofol administration, Intermittent propofol dosing, intermittent propofol administration, Sedative agent, propofol continuous infusions, Recovery time, Complications of sedation, bolus dosing