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Completed

NCT Number: NCT02253199

The Effect of Age on the Median Effective Dose (ED50) of Intranasal Dexmedetomidine for Rescue Sedation Following Failed Sedation With Oral Chloral Hydrate During Magnetic Resonance Imaging

Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children. We performed a up-down sequential allocation study to determine the ED50 for rescue sedation following sedation failures in children and to investigate age-related differences in the rescue sedation with dexmedetomidine.

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Key information

Conditions

Aged Dose-Response Relationship Drug

Age range

1 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology of Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510000, China

About this study

About 150 children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) were stratified into four age groups as follows: 1-6 month, 7 -12 month, 13 -24 month, and 25-36 month. The intranasal dexmedetomidine dose was determined by the success or failure of rescue sedation achieved by the previous patients, according to Dixon's up-down sequential allocation method. Successful sedation was defined as a MOAA/S(modified Observer Assessment of Alertness and Sedation) of between 0 and 3. The EC50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression. Patients' sedation status, sedation induction time, time to Wake up, blood pressure, heart rate, and oxygen saturation were recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 150 children of ASA physical status I or II, aged between 1 and 36 months, failed chloral hydrate sedation during MRI scanning,

Exclusion criteria

  • known allergy or hypersensitive reaction to drugs of this study, Weight greater than 20 kg or less than 4.5 kg, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia and congenital heart disease.

Treatment and study plan

Intranasal dexmedetomidine

Drug

Children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) received a bolus of intranasal dexmedetomidine which adjusted by the "Dixon up-and-down method for rescue sedation.

The first child received 0.8mcg/Kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose interval was set at 0.1mcg/Kg.

Primary outcomes

  1. The median effect dose of intranasal dexmedetomidine

    Time frame: up to 1 hours after MRI scaning

    Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S).successful sedation was defined as an MOAA/S of between 0 and 3

Secondary outcomes

  1. sedation induction time

    Time frame: up to 30 min after rescue drug administration

    Successful sedation was defined as an MOAA/S of between 0 and 3, and sedation induction time was defined as the time from rescue drug administration to the onset of satisfactory sedation

    0 Does not respond to a noxious stimulus

    • Does not respond to mild prodding or shaking
    • Responds only after mild prodding or shaking
    • Responds only after name is called loudly orrepeatedly
    • Lethargic response to name spoken in normal tone
    • Appears asleep, but responds readily to namespoken in normal tone
    • Appears alert and awake, responds readily to namespoken in normal tone

  2. Wake -up time

    Time frame: up to 4 hours after rescue drug administration

    Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke

Other outcomes

  1. heart rate

    Time frame: baseline, before and 15 , 60, 75, 90 min after rescue drug administration

    changes in heart rates at the baseline, before and 15 , 60, 75, 90 min after rescue drug administration

  2. non-invasive systolic blood pressure

    Time frame: baseline, before and 15 , 60, 75, 90 min after rescue drug administration

    changes in the non-invasive systolic blood pressure at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration

  3. Oxyhemoglobin desaturation

    Time frame: baseline and four hours after rescue medicine administration

    Significant Oxyhemoglobin desaturation was defined as<94%

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 1, 2014
Registry last updated
Mar 29, 2016

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

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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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