Clinical trial NCT02253199: The Effect of Age on the Median Effective Dose (ED50) of Intranasal Dexmedetomidine for Rescue Sedation Following Failed Sedation With Oral Chloral Hydrate During Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aged
Drug
Dose-Response Relationship
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children. We performed a up-down sequential allocation study to determine the ED50 for rescue sedation following sedation failures in children and to investigate age-related differences in the rescue sedation with dexmedetomidine.

Detailed description: About 150 children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) were stratified into four age groups as follows: 1-6 month, 7 -12 month, 13 -24 month, and 25-36 month. The intranasal dexmedetomidine dose was determined by the success or failure of rescue sedation achieved by the previous patients, according to Dixon's up-down sequential allocation method. Successful sedation was defined as a MOAA/S(modified Observer Assessment of Alertness and Sedation) of between 0 and 3. The EC50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression. Patients' sedation status, sedation induction time, time to Wake up, blood pressure, heart rate, and oxygen saturation were recorded.

Eligibility criteria: Inclusion Criteria:

* 150 children of ASA physical status I or II, aged between 1 and 36 months, failed chloral hydrate sedation during MRI scanning,

Exclusion Criteria:

* known allergy or hypersensitive reaction to drugs of this study, Weight greater than 20 kg or less than 4.5 kg, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia and congenital heart disease.

Primary outcomes:
measure: The median effect dose of intranasal dexmedetomidine
timeFrame: up to 1 hours after MRI scaning
Secondary outcomes:
measure: sedation induction time
timeFrame: up to 30 min after rescue drug administration
measure: Wake -up time
timeFrame: up to 4 hours after rescue drug administration
Other outcomes:
measure: heart rate
timeFrame: baseline, before and 15 , 60, 75, 90 min after rescue drug administration
measure: non-invasive systolic blood pressure
timeFrame: baseline, before and 15 , 60, 75, 90 min after rescue drug administration
measure: Oxyhemoglobin desaturation
timeFrame: baseline and four hours after rescue medicine administration
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesiology of Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
References:
citation: Zhang W, Fan Y, Zhao T, Chen J, Zhang G, Song X. Median Effective Dose of Intranasal Dexmedetomidine for Rescue Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging. Anesthesiology. 2016 Dec;125(6):1130-1135. doi: 10.1097/ALN.0000000000001353.