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Completed

NCT Number: NCT02996058

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

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.

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Key information

Conditions

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dexmedetomidine 0.35µg/kg /h

Drug

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

Other names: Precedex

Dexmedetomidine 0.5µg/kg /h

Drug

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

Other names: Precedex

Primary outcomes

  1. University of Michigan sedation scale

    Time frame: 72H

    The university of Michigan sedation scale (UMSS) will be assessed every hour

Secondary outcomes

  1. The blood pressure

    Time frame: 72h

    The invasive arterial blood pressure will be recorded every hour

  2. The heart rate

    Time frame: 72h

    The heart rate will be recorded every hour.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Dexmedetomidine Sedation in Pediatric Intensive Care Unit

Acronym: DEXinPICU

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2016
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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