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

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ClinicalTrials.gov Identifier: NCT02239445
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Wenhua Zhang, Guangzhou Women and Children's Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Administration Related Reaction Failed Moderate Sedation During Procedure Chloral Hydrate Adverse Reaction Drug: chloral hydrate Group Drug: low dose dexmedetomidine group Drug: high dose dexmedetomidine group Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Study Start Date : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: chloral hydrate group
chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)
 Drug: chloral hydrate Group
chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)
Experimental: low dose dexmedetomidine Group

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

Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.

 Drug: low dose dexmedetomidine group
Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup
Other Name: AiBeiNing
Experimental: high dose dexmedetomidine group

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

Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.

 Drug: high dose dexmedetomidine group
Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup
Other Name: AiBeiNing


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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

    1. Does not respond to mild prodding or shaking
    2. Responds only after mild prodding or shaking
    3. Responds only after name is called loudly orrepeatedly
    4. Lethargic response to name spoken in normal tone
    5. Appears asleep, but responds readily to namespoken in normal tone
    6. 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 Outcome Measures:
  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%


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239445


Locations
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China, Guangdong
Department of Anesthesiology of Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510000
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wenhua Zhang, Bureau of Health of Guangzhou, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT02239445    
Other Study ID Numbers: WZhang
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Dexmedetomidine
Chloral Hydrate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action