Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging
1 other identifier
interventional
158
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2014
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 4, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 12, 2015
May 1, 2015
8 months
September 4, 2014
May 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
sedation induction time
up to 30 min after rescue drug administration
Wake -up time
up to 4 hours after rescue drug administration
Other Outcomes (3)
non-invasive systolic blood pressure
baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration
heart rate
baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration
Oxyhemoglobin desaturation
baseline and four hours after rescue medicine administration
Study Arms (3)
chloral hydrate group
ACTIVE COMPARATORchloral 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
EXPERIMENTALGroup 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
EXPERIMENTALGroup 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.
Interventions
chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)
Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup
Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup
Eligibility Criteria
You may qualify if:
- children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Anesthesiology of Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510000, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Related Publications (3)
Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
PMID: 34397100DERIVEDZhang W, Wang Z, Song X, Fan Y, Tian H, Li B. Comparison of rescue techniques for failed chloral hydrate sedation for magnetic resonance imaging scans--additional chloral hydrate vs intranasal dexmedetomidine. Paediatr Anaesth. 2016 Mar;26(3):273-9. doi: 10.1111/pan.12824. Epub 2015 Dec 30.
PMID: 26714442DERIVEDMiller J, Xue B, Hossain M, Zhang MZ, Loepke A, Kurth D. Comparison of dexmedetomidine and chloral hydrate sedation for transthoracic echocardiography in infants and toddlers: a randomized clinical trial. Paediatr Anaesth. 2016 Mar;26(3):266-72. doi: 10.1111/pan.12819. Epub 2015 Nov 30.
PMID: 26616644DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Bureau of Health of Guangzhou
Study Record Dates
First Submitted
September 4, 2014
First Posted
September 12, 2014
Study Start
September 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 12, 2015
Record last verified: 2015-05