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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05091151
• Other study ID #: IndonesiaUAnes118
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Deep Sedation
• Magnetic Resonance Imaging
• Pediatric ALL

Intervention

Drug:
• Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg
Intranasal dexmedetomidine were given 45 minutes before the MRI procedure through both nostrils using a 1 mL syringe.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

Gupta A, Dalvi NP, Tendolkar BA. Comparison between intranasal dexmedetomidine and intranasal midazolam as premedication for brain magnetic resonance imaging in pediatric patients: A prospective randomized double blind trial. J Anaesthesiol Clin Pharmacol — View Citation

Li BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, Song XR, Yuen VM, Irwin MG. A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016 May;71(5):522-8. doi: 10.1111/anae.13407. Epub 2 — View Citation

Olgun G, Ali MH. Use of Intranasal Dexmedetomidine as a Solo Sedative for MRI of Infants. Hosp Pediatr. 2018 Jan 23. pii: hpeds.2017-0120. doi: 10.1542/hpeds.2017-0120. [Epub ahead of print] — View Citation

Schmitz A, Weiss M, Kellenberger C, O'Gorman Tuura R, Klaghofer R, Scheer I, Makki M, Sabandal C, Buehler PK. Sedation for magnetic resonance imaging using propofol with or without ketamine at induction in pediatrics-A prospective randomized double-blinde — View Citation

Tug A, Hanci A, Turk HS, Aybey F, Isil CT, Sayin P, Oba S. Comparison of Two Different Intranasal Doses of Dexmedetomidine in Children for Magnetic Resonance Imaging Sedation. Paediatr Drugs. 2015 Dec;17(6):479-85. doi: 10.1007/s40272-015-0145-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recovery time	This study compared the recovery time in IND 2 to IND 4 group.; Operational definition: Time calculated from the completion of the MRI procedure until the Aldrete score 9 is achieved; (The Aldrete's scoring system is a commonly used scale for determining when patient can be safely discharged from the post-anesthesia care unit. A score of 8-10 is considered adequate to discharge a patient from Phase I of post anesthesia care.)	Up to 2 hours after MRI procedure has been completed
Other	Adverse effect	This study compared the adverse effect occured in IND 2 to IND 4 group.; The acute side effects of sedation, including: Bradycardia (Heart Rate < 60 x/min and/or decrease in HR > 20% from baseline) Desaturation (Moderate desaturation if SpO2 < 95% for 15 seconds, Severe desaturation if SpO2 < 90% for 15 seconds) Allergic reaction (rash, itchy sensation, and hypotension)	During MRI procedure dan recovery time
Other	Rescue dose of Propofol needed	This study compared the amount of rescue dose of propofol needed in IND2 to IND4 group.; This study calculated the amount of rescue dose of propofol needed during the MRI procedure under following conditions: If sedation targets are not achieved, inadequate, or the patient is immobile, boluses of propofol 0.5 mg/kg intravenously could be given to the patient.	During MRI procedure
Primary	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	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