Clinical trial NCT05091151: Intranasal Dexmedetomidine Sedation at Dose of 2 mcg/kg Versus 4 mcg/kg in Children Undergoing MRI
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Deep Sedation
Magnetic Resonance Imaging
Pediatric ALL
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 94
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Onset sedation time of Intranasal dexmedetomidine.
timeFrame: 45 minutes before MRI procedure.
Secondary outcomes:
measure: Duration of Sedation
timeFrame: During MRI procedure
Other outcomes:
measure: Recovery time
timeFrame: Up to 2 hours after MRI procedure has been completed
measure: Adverse effect
timeFrame: During MRI procedure dan recovery time
measure: Rescue dose of Propofol needed
timeFrame: During MRI procedure
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
References:
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.
citation: 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. 2017 Apr-Jun;33(2):236-240. doi: 10.4103/joacp.JOACP_204_16.
citation: Olgun G, Ali MH. Use of Intranasal Dexmedetomidine as a Solo Sedative for MRI of Infants. Hosp Pediatr. 2018 Jan 23:hpeds.2017-0120. doi: 10.1542/hpeds.2017-0120. Online ahead of print.
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 2016 Mar 3.
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-blinded study. Paediatr Anaesth. 2018 Mar;28(3):264-274. doi: 10.1111/pan.13315. Epub 2018 Jan 27.