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

Study Overview
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Brief Summary
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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.

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

Intervention / Treatment
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* Drug: chloral hydrate Group
* Drug: low dose dexmedetomidine group
* Drug: high dose dexmedetomidine group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: chloral hydrate group<br>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<br>* chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)<br>|
| Experimental: low dose dexmedetomidine Group<br>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<br>* Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup<br>* Other names: AiBeiNing;|
| Experimental: high dose dexmedetomidine group<br>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<br>* Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup<br>* Other names: AiBeiNing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful rescue sedation rate | 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 | up to 1 hours after MRI scaning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation induction time | 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 | up to 30 min after rescue drug administration | 
| Wake -up time | 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 | up to 4 hours after rescue drug administration |