Intranasal Dexmedetomidine Sedation at Dose of 2 mcg/kg Versus 4 mcg/kg in Children Undergoing MRI

Study Overview
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Brief Summary
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This study aimed to compare the effectiveness of intranasal Dexmedetomidine sedation at Dose of 2 mcg/kg and 4 mcg/kg in Children Undergoing MRI at Cipto Mangunkusumo Hospital

Detailed Description
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Ninety-four pediatric subjects who would undergo MRI with sedation were recruited. Subjects aged between 1-10 years old, ASA I-II, weighed between 1-30 kg were included in this study and assigned into two groups randomly. One group received 2 mcg/kg (IND2 group) and the other group received 4 mcg/kg (IND 4 group) of intranasal dexmedetomidine. Randomization was done by the third party, who was not participated in the data collection, by using randomization tool from www.randomizer.org. Dose of intranasal dexmedetomidine for each participant was concealed using closed envelope and was opened preprocedure by the second party who prepared the sedation drugs. The doctor, who gave sedation drug to the patient and recorded the data, was also blinded. All patients were blinded to data collection. Patients were allowed to drink clear fluid until 2 hours and required to fast for 6 hours before the procedure. Baseline heart rate, SpO2 was recorded premedication. Subjects in IND 2 and IND 4 group received 2 mcg/kg and 4 mcg/kg intranasal dexmedetomidine. Intranasal drugs were given 45 minutes before the MRI procedure through both nostrils using a 1 mL syringe. Patient was maintained in supine position for 1-2 minutes to maximize absorption. After the patient was sedated, peripheral intravenous access was performed. The level of sedation was assessed using RSS. Heart rate, oxygen saturation, and RSS are recorded every 10 minutes until the procedure was done. After the target sedation has been reached, MRI started immediately. If the sedation target was not reached and/or the child moved, 0.5 mg/kg rescue dose of propofol would be given. After completing the MRI procedure, the patient was then transferred to the recovery room to record the recovery time. Outpatients were allowed to go home when they reached Aldrete score of 9-10.

Official Title
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Comparison of The Effectiveness of Intranasal Dexmedetomidine Sedation at Dose of 2 mcg/kg and 4 mcg/kg in Children Undergoing MRI at Cipto Mangunkusumo Hospital

Conditions
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Anesthesia, Deep Sedation, Magnetic Resonance Imaging, Pediatric ALL

Intervention / Treatment
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* Drug: Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged between 1-10 years old undergoing MRI ASA I-II Weighed between 1-30 kg Exclusion Criteria: Patients who had history of hypersensitivity reaction to dexmedetomidine or showed an allergic reaction due to sedation drugs during MRI examination. Patients with cardiorespiratory, liver, kidney problems, risk of difficult airway, undergoing digoxin or beta blocker therapy, and failed to be sedated after 45 minutes since drug administered.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intranasal dexmedetomidine at dose of 2 mcg/kg<br>Subjects in IND 2 group received Intranasal dexmedetomidine at dose of 2 mcg/kg, before the MRI procedure through both nostrils using a 1 mL syringe. Patient was maintained in supine position for 1-2 minutes to maximize absorption. | Drug: Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg<br>* Intranasal dexmedetomidine were given 45 minutes before the MRI procedure through both nostrils using a 1 mL syringe.<br>|
| Active Comparator: Intranasal dexmedetomidine at dose of 4 mcg/kg.<br>Subjects in IND 4 group received Intranasal dexmedetomidine at dose of 4 mcg/kg, before the MRI procedure through both nostrils using a 1 mL syringe. Patient was maintained in supine position for 1-2 minutes to maximize absorption. | Drug: Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg<br>* Intranasal dexmedetomidine were given 45 minutes before the MRI procedure through both nostrils using a 1 mL syringe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset sedation time of Intranasal dexmedetomidine. | This study compared the onset time of IND 2 to IND 4 group. Operational definition: Time taken from drug induction to achieve sedation (Ramsay sedation score 5). Ramsay Sedation Scoring system : Patient is anxious and agitated or restless, or both Patient is co-operative, oriented, and tranquil Patient responds to commands only Patient exhibits brisk response to light glabellar tap or loud auditory stimulus Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus Patient exhibits no response | 45 minutes before MRI procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Sedation | This study compared the duration of sedation of IND 2 to IND 4 group. Operational definition: Time taken from achieving the sedation target to Ramsay's sedation score 3 Ramsay Sedation Scoring system : Patient is anxious and agitated or restless, or both Patient is co-operative, oriented, and tranquil Patient responds to commands only Patient exhibits brisk response to light glabellar tap or loud auditory stimulus Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus Patient exhibits no response | During MRI procedure |