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NCT Number: NCT05091151

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

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

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Key information

Conditions

Anesthesia Deep Sedation Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Magnetic Resonance Imaging Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Onset sedation time of Intranasal dexmedetomidine.

    Time frame: 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 :

    • 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

Secondary outcomes

  1. Duration of Sedation

    Time frame: 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 :

    • 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

Other outcomes

  1. Recovery time

    Time frame: Up to 2 hours after MRI procedure has been completed

    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.)

  2. Adverse effect

    Time frame: During MRI procedure dan recovery time

    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)

  3. Rescue dose of Propofol needed

    Time frame: During MRI procedure

    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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2021
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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