Informations générales (source: ClinicalTrials.gov)
Addition of Neuromuscular-Blocking Agents During Sevoflurane Induction in Infants : Potential Interest in Reducing Hypoxemia Episodes (ROC-HYPOX)
Interventional
Phase 4
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
décembre 2015
décembre 2025
29 juin 2024
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Marion ANDREOLETTI | 29/03/2024 01:28:20 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Anoushee SHAFFII | 21/06/2024 13:31:15 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Robert Debré | Souhayl DAHMANI, Pr | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Jeanne de Flandre, CHRU de Lille - 59000 - Lille - France | Francis Veyckemans, Dr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Toulouse - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- age <2 years
- indication of general anesthesia with tracheal intubation
- inhalational induction scheduled
- written informed consent of both parents
- age <2 years
- indication of general anesthesia with tracheal intubation
- inhalational induction scheduled
- written informed consent of both parents
- contra-indication to inhalational induction (full stomach)
- contra-indication to the use of rocuronium
- American Society of Anesthesiologists score (ASA) III or IV
- intracranial surgery
- parental refusal
- absence of affiliation to social security