Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging
- Conditions
- Administration Related ReactionFailed Moderate Sedation During ProcedureChloral Hydrate Adverse Reaction
- Interventions
- Registration Number
- NCT02239445
- Lead Sponsor
- Guangzhou Women and Children's Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
- 160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description chloral hydrate group 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) low dose dexmedetomidine Group 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. high dose dexmedetomidine group 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.
- Primary Outcome Measures
Name Time Method successful rescue sedation rate 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
Name Time Method sedation induction time 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 toneWake -up time 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
Trial Locations
- Locations (2)
Department of Anesthesiology of Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, Guangdong, China
Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, Guangdong, China