Clinical trial NCT02589691: Neuromuscular-Blocking Agents and Hypoxemia During Intubation in Infants (ROC-HYPOX)
Official title: Addition of Neuromuscular-Blocking Agents During Sevoflurane Induction in Infants : Potential Interest in Reducing Hypoxemia Episodes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypoxemia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-10-28
Enrollment: 412
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: Inclusion Criteria:

* age \<2 years
* indication of general anesthesia with tracheal intubation
* inhalational induction scheduled
* written informed consent of both parents

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence, expressed as a percentage, of at least on episode of hypoxemia, defined as an arterial oxygen saturation <90%, obtained by continuous measurement of pulse oximetry.
timeFrame: Up to 15 minutes after anesthesia induction
Secondary outcomes:
measure: Cumulative duration of hypoxemia expressed in seconds and defined as an arterial oxygen saturation <90%
timeFrame: Up to 15 minutes after anesthesia induction
measure: Cumulative duration, expressed in seconds, with a decreased in arterial oxygen saturation of 5% as compared to the arterial oxygen saturation at baseline
timeFrame: Up to 15 minutes after anesthesia induction
measure: Lowest recorded value of arterial oxygen saturation.
timeFrame: Up to 15 minutes after anesthesia induction
measure: Incidence, expressed as a percentage, of at least one episode of bronchospasm
timeFrame: Up to 15 minutes after anesthesia induction
measure: Incidence, expressed as a percentage, of at least one episode of laryngospasm
timeFrame: Up to 15 minutes after anesthesia induction
measure: Duration, expressed in seconds, of apnea
timeFrame: Up to 15 minutes after anesthesia induction
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal Creteil (CHIC)
city: Lille
country: France
facility: Hôpital Jeanne de Flandre, CHRU de Lille
city: Paris
country: France
facility: Hôpital Necker-Enfants malades
city: Paris
country: France
facility: Hopital Robert Debre
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
References: