NCT02589691

Neuromuscular-Blocking Agents and Hypoxemia During Intubation in Infants (ROC-HYPOX)

Addition of Neuromuscular-Blocking Agents During Sevoflurane Induction in Infants : Potential Interest in Reducing Hypoxemia Episodes

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 412 (estimated)
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild · Network
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The prevention of the occurrence of respiratory events is a constant concern in pediatric anesthesia, as these represent the main cause of the anesthesic mortality. These events occur partly during induction of anesthesia and are all the more frequent as the child is young. The French recommendations do not propose the use of neuromuscular-blocking agents in pediatric anesthesia. This recommendation is controversial In a recently published study, it has been shown that the use of neuromuscular blocking agents during induction in children under 2 years improves intubating conditions and reduces the incidence of hemodynamic and respiratory events. This monocentric study, centered on intubating conditions, does not allow to conclude on the influence of muscle relaxants on reduction of the respiratory morbidity. The objective of study is to demonstrate that, in children under 2 years, changing the anesthesia protocol can reduce the incidence and severity of episodes of hypoxemia associated with respiratory events occurring during induction

Conditions

• Hypoxemia

Interventions

Type	Name	Description
DRUG	Rocuronium
OTHER	Sodium chloride 0.9%

Timeline

• Start date: 2015-12-23
• Primary completion: 2024-12-23
• Completion: 2025-12-23
• First posted: 2015-10-28
• Last updated: 2023-07-18

Locations

6 sites across 1 country: France