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

NCT05091151 | Completed DMC

• 1 other identifier: IndonesiaUAnes118
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia; Deep Sedation; Magnetic Resonance Imaging; Pediatric ALL

Outcome Measures

Primary Outcomes (1)

• 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 : 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

  45 minutes before MRI procedure.

Secondary Outcomes (1)

• Duration of Sedation

  During MRI procedure

Other Outcomes (3)

• Recovery time

  Up to 2 hours after MRI procedure has been completed

• Adverse effect

  During MRI procedure dan recovery time

• Rescue dose of Propofol needed

  During MRI procedure

Study Arms (2)

Intranasal dexmedetomidine at dose of 2 mcg/kg

ACTIVE COMPARATOR

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

Intranasal dexmedetomidine at dose of 4 mcg/kg.

ACTIVE COMPARATOR

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

Interventions

Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg DRUG

Intranasal dexmedetomidine were given 45 minutes before the MRI procedure through both nostrils using a 1 mL syringe.

Intranasal dexmedetomidine at dose of 2 mcg/kg; Intranasal dexmedetomidine at dose of 4 mcg/kg.

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects aged between 1-10 years old undergoing MRI
• ASA I-II
• Weighed between 1-30 kg

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (5)

• 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.

  PMID: 26323489 RESULT

• 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.

  PMID: 28781452 RESULT

• 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.

  PMID: 29363517 RESULT

• 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.

  PMID: 26936022 RESULT

• 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.

  PMID: 29377404 RESULT

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Adhrie Sugiarto, SpAn KIC

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 25, 2021
• Study Start: February 1, 2019
• Primary Completion: April 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)