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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocuronium | Experimental | Intra-venous injection during induction anesthesia of 0.3 mg/kg (1 mL/kg) of rocuronium |
|
| Placebo | Placebo Comparator | Intra-venous injection during induction anesthesia of 1 mL/kg of sodium chloride 0.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug |
| ||
| Sodium chloride 0.9% |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal Creteil (CHIC) | Completed | Créteil | 94000 | France | ||
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| 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 |
| Hôpital Jeanne de Flandre, CHRU de Lille |
| Recruiting |
| Lille |
| 59000 |
| France |
|
| Hôpital Necker-Enfants malades | Completed | Paris | 75015 | France |
| Hopital Robert Debre | Recruiting | Paris | 75019 | France |
|
| Hôpital Fondation Adolphe de Rothschild | Recruiting | Paris | 75019 | France |
|
| CHU de Toulouse | Completed | Toulouse | 31059 | France |
| D011083 |
| Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |