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

Study Overview
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Brief Summary
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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

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

Conditions
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Hypoxemia

Intervention / Treatment
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* Drug: Rocuronium
* Other: Sodium chloride 0.9%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rocuronium<br>Intra-venous injection during induction anesthesia of 0.3 mg/kg (1 mL/kg) of rocuronium | Drug: Rocuronium<br> <br> |
| Placebo Comparator: Placebo<br>Intra-venous injection during induction anesthesia of 1 mL/kg of sodium chloride 0.9% | Other: Sodium chloride 0.9%<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Lowest recorded value of arterial oxygen saturation. |  | 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 |