Hypoxemia
Conditions
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
Interventions
DRUGRocuronium
OTHERSodium chloride 0.9%
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Up to 15 minutes after anesthesia induction |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative duration of hypoxemia expressed in seconds and defined as an arterial oxygen saturation <90% | Up to 15 minutes after anesthesia induction |
| Cumulative duration, expressed in seconds, with a decreased in arterial oxygen saturation of 5% as compared to the arterial oxygen saturation at baseline | Up to 15 minutes after anesthesia induction |
| Incidence, expressed as a percentage, of at least one episode of bronchospasm | Up to 15 minutes after anesthesia induction |
| Incidence, expressed as a percentage, of at least one episode of laryngospasm | Up to 15 minutes after anesthesia induction |
| Duration, expressed in seconds, of apnea | Up to 15 minutes after anesthesia induction |
| Lowest recorded value of arterial oxygen saturation. | Up to 15 minutes after anesthesia induction |
Countries
France
Outcome results
None listed