Using neuromuscular-blocking agents to reduce hypoxemia during intubation in infants
Addition of Neuromuscular-Blocking Agents During Sevoflurane Induction in Infants : Potential Interest in Reducing Hypoxemia Episodes
This study is testing if using a muscle relaxant during intubation can help prevent low oxygen levels in infants under 2 years old.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 412 (estimated) |
| Ages | N/A to 2 Years |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 6 sites (Créteil and 5 other locations) |
| Trial ID | NCT02589691 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of neuromuscular-blocking agents on the incidence of hypoxemia during intubation in infants under 2 years of age. It aims to modify the anesthesia protocol to improve intubating conditions and reduce respiratory complications associated with general anesthesia. The study will compare the effects of rocuronium against a placebo (sodium chloride) in a controlled setting. By focusing on a specific age group and anesthesia method, the study seeks to provide clearer insights into the safety and efficacy of these agents in pediatric anesthesia.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under 2 years old who require general anesthesia with tracheal intubation.
Not a fit: Patients with contraindications to inhalational induction or the use of rocuronium, as well as those with severe comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and reduced respiratory complications during anesthesia in young children.
How similar studies have performed: Previous studies have shown promising results regarding the use of neuromuscular-blocking agents in pediatric anesthesia, suggesting potential benefits in similar approaches.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Créteil and 5 other locations
- Centre Hospitalier Intercommunal Creteil (CHIC) — Créteil, France (Completed)
- Hôpital Jeanne de Flandre, CHRU de Lille — Lille, France (Recruiting)
- Hôpital Necker-Enfants malades — Paris, France (Completed)
- Hopital Robert Debre — Paris, France (Recruiting)
- Hôpital Fondation Adolphe de Rothschild — Paris, France (Recruiting)
- CHU de Toulouse — Toulouse, France (Completed)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.