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AnesthesiaNCT05091151

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

A study testing Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg in people with Anesthesia and Deep Sedation, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 1 year to 10 yearsHealthy volunteers can take part
What is being tested?
Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteIndonesia
Study dates
1 Feb 2019to 30 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo General Hospital

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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

Read the 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.

Being tested
Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kgDrug

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

Study groups in NCT05091151
Study groupRoleWhat they receive
Intranasal dexmedetomidine at dose of 2 mcg/kgActive comparatorSubjects 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.
Receives: Drug: Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg
Intranasal dexmedetomidine at dose of 4 mcg/kg.Active comparatorSubjects 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.
Receives: Drug: Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 45 minutes before MRI procedure.

Secondary outcomes (1)

  1. 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 :

    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

    Measured: During MRI procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start1 Feb 2019
  3. Primary completion30 Apr 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05091151
Sponsor's protocol ID
IndonesiaUAnes118
Status last verified
Oct 2021
First submitted
21 Sep 2021
Last updated
25 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26323489

  • 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.

    PubMed 28781452

  • 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.

    PubMed 29363517

  • 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.

    PubMed 26936022

  • 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.

    PubMed 29377404

Questions about this trial

What is this clinical trial studying?

A study testing Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg in people with Anesthesia and Deep Sedation, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset sedation time of Intranasal dexmedetomidine. (time frame: 45 minutes before MRI procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05091151, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.

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