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

Aged Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253199
• Other study ID #: WZhang-02
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2014
• Last updated: March 26, 2016
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Guangzhou Women and Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 36 Months

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator)

Related Conditions & MeSH terms

• Aged
• Dose-Response Relationship
• Drug

Intervention

Drug:
• intranasal dexmedetomidine
Children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) received a bolus of intranasal dexmedetomidine which adjusted by the "Dixon up-and-down method for rescue sedation. The first child received 0.8mcg/Kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose interval was set at 0.1mcg/Kg.

Locations

Country	Name	City	State
China	Department of Anesthesiology of Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	heart rate	changes in heart rates at the baseline, before and 15 , 60, 75, 90 min after rescue drug administration	baseline, before and 15 , 60, 75, 90 min after rescue drug administration	Yes
Other	non-invasive systolic blood pressure	changes in the non-invasive systolic blood pressure at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration	baseline, before and 15 , 60, 75, 90 min after rescue drug administration	Yes
Other	Oxyhemoglobin desaturation	Significant Oxyhemoglobin desaturation was defined as<94%	baseline and four hours after rescue medicine administration	Yes
Primary	The median effect dose of intranasal dexmedetomidine	Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S).successful sedation was defined as an MOAA/S of between 0 and 3	up to 1 hours after MRI scaning	Yes
Secondary	sedation induction time	Successful sedation was defined as an MOAA/S of between 0 and 3, 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	Yes
Secondary	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	Yes