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

NCT02996058 | Completed Phase 2 DMC

• 1 other identifier: IRB00008718/00436
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• University of Michigan sedation scale

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

  72H

Secondary Outcomes (2)

• The blood pressure

  72h

• The heart rate

  72h

Study Arms (2)

DEX I 0.35µg/kg /h

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine 0.35µg/kg /h

DEX II 0.5µg/kg /h

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine 0.5µg/kg /h

Interventions

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

Also known as: Precedex

DEX I 0.35µg/kg /h

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

Also known as: Precedex

DEX II 0.5µg/kg /h

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hala S Abdel-Ghaffar, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)