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

NCT ID: NCT02996058

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-07-31

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.

Conditions

Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DEX I 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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine 0.35µg/kg /h

Intervention Type: 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

DEX II 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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine 0.5µg/kg /h

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Precedex; Precedex

Eligibility Criteria

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).

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

Locations

Pediatric hospital

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB00008718/00436

Identifier Type: -

Identifier Source: org_study_id