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

NCT02253199 | Completed Phase 4 DMC

• 1 other identifier: WZhang-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged; Drug; Dose-Response Relationship

Outcome Measures

Primary Outcomes (1)

• 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

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)

• heart rate

  baseline, before and 15 , 60, 75, 90 min after rescue drug administration

• non-invasive systolic blood pressure

  baseline, before and 15 , 60, 75, 90 min after rescue drug administration

• Oxyhemoglobin desaturation

  baseline and four hours after rescue medicine administration

Study Arms (4)

1-6 months (Group 1)

ACTIVE COMPARATOR

Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).

Drug: intranasal dexmedetomidine

7-12 months (Group 2)

ACTIVE COMPARATOR

Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).

Drug: intranasal dexmedetomidine

13-24 months (Group 3)

ACTIVE COMPARATOR

Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).

Drug: intranasal dexmedetomidine

25-36 months (Group 4)

ACTIVE COMPARATOR

Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4).

Drug: intranasal dexmedetomidine

Interventions

intranasal dexmedetomidine DRUG

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.

1-6 months (Group 1); 13-24 months (Group 3); 25-36 months (Group 4); 7-12 months (Group 2)

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (1)

Department of Anesthesiology of Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 27627818 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Resesearch

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 1, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

CN (1)