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Completed

NCT Number: NCT02239445

Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging

The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.

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Key information

Conditions

Administration Related Reaction Chloral Hydrate Adverse Reaction Failed Moderate Sedation During Procedure

Age range

1 month–6 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, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning

Exclusion criteria

  • known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or and congenital heart disease.

Treatment and study plan

chloral hydrate Group

Drug

chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)

low dose dexmedetomidine group

Drug

Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup

Other names: AiBeiNing

high dose dexmedetomidine group

Drug

Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup

Other names: AiBeiNing

Primary outcomes

  1. successful rescue sedation rate

    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 Observer Assessment of Alertness and Sedation Scale (MOAA/S; Table 1).

    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 2, 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. non-invasive systolic blood pressure

    Time frame: baseline, before and 15 , 30, 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

  2. heart rate

    Time frame: baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration

    changes in heart rates 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
2015
Study completion
2015
First posted
Sep 12, 2014
Registry last updated
May 12, 2015

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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