Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure

Phase 2

Completed

• Conditions: Sedation
• Interventions: Drug: Dexmedetomidine 0.5µg/kg /h; Drug: Dexmedetomidine 0.35µg/kg /h

• Registration Number: NCT02996058
• Lead Sponsor: Assiut University

Brief Summary

Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.

Detailed Description

Critically ill children require sedation for comfort and to facilitate mechanical ventilation and interventions. The ideal sedative agent for use in critically ill children has to be effective and short-acting, of rapid onset of action, lacks active metabolites, does not accumulate in patients with renal or hepatic dysfunction, has minimal to no cardiovascular or respiratory adverse effects, and has few drug interactions.

Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.

The only FDA approved indication of dexmedetomidine is sedation of intubated mechanically ventilated adults for less than 24h. However, the literature is full of many research studies that investigated the use off-lable use of dexmedetomidine for sedation more than 24h in both adult and pediatric population and proved its safety and effectiveness.

The aim of this study will be to investigate the safety and efficacy of dexmedetomidine in two different doses in sedation for critically ill mechanically ventilated infants with respiratory failure for 72h duration.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-19
• Primary Completion: 2018-03
• Status Verified: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2018-07-01
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Infants (1-12 months).
• Respiratory failure/
• Requiring PICU admission and mechanical ventilation up to 72h.

Exclusion Criteria

• Significant renal, hepatic, endocrine or metabolic disease.
• 2nd or 3rd degree heart block.
• hypotension or bradycardia (defined as any value outside the normal range from the patient's age).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEX II 0.5µg/kg /h	Dexmedetomidine 0.5µg/kg /h	the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale.
DEX I 0.35µg/kg /h	Dexmedetomidine 0.35µg/kg /h	the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale

Primary Outcome Measures

Name	Time	Method
University of Michigan sedation scale	72H	The university of Michigan sedation scale (UMSS) will be assessed every hour

Secondary Outcome Measures

Name	Time	Method
The blood pressure	72h	The invasive arterial blood pressure will be recorded every hour
The heart rate	72h	The heart rate will be recorded every hour.

Trial Locations

Locations (1)

Pediatric hospital; 🇪🇬 Assiut, Assiut Governorate, Egypt