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

Not Applicable

Completed

• Conditions: Anesthesia; Deep Sedation; Magnetic Resonance Imaging; Pediatric ALL
• Interventions: Drug: Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg

• Registration Number: NCT05091151
• Lead Sponsor: Indonesia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-06-30
• Study First Submitted: 2021-09-21
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-13
• Last Update Submitted: 2021-10-13
• Study First Posted: 2021-10-25
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal dexmedetomidine at dose of 2 mcg/kg	Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg	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.
Intranasal dexmedetomidine at dose of 4 mcg/kg.	Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg	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.

Primary Outcome Measures

Name	Time	Method
Onset sedation time of Intranasal dexmedetomidine.	45 minutes before MRI procedure.	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 : 1. Patient is anxious and agitated or restless, or both; 2. Patient is co-operative, oriented, and tranquil; 3. Patient responds to commands only; 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6. Patient exhibits no response

Secondary Outcome Measures

Name	Time	Method
Duration of Sedation	During MRI procedure	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 : 1. Patient is anxious and agitated or restless, or both; 2. Patient is co-operative, oriented, and tranquil; 3. Patient responds to commands only; 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6. Patient exhibits no response

Trial Locations

Locations (1)

Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia