Clinical trial

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

Name
FDE_2014_25
Description
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
Trial arms
Trial start
2015-12-23
Estimated PCD
2024-12-23
Trial end
2025-12-23
Status
Recruiting
Phase
Early phase I
Treatment
Rocuronium
Arms:
Rocuronium
Sodium chloride 0.9%
Arms:
Placebo
Size
412
Primary endpoint
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
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 412, 'type': 'ESTIMATED'}}
Updated at
2023-07-18

1 organization

1 product

1 indication

Product
Rocuronium
Indication
Hypoxemia