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

Hypoxemia Clinical Trial

— ROC-HYPOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02589691
• Other study ID #: FDE_2014_25
• Status: Recruiting
• Phase: Phase 4
• Start date: December 23, 2015
• Est. completion date: December 23, 2025

Study information

• Verified date: March 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 412
• Est. completion date: December 23, 2025
• Est. primary completion date: December 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

Drug:
• Rocuronium

Other:
• Sodium chloride 0.9%

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Creteil (CHIC)	Créteil
France	Hôpital Jeanne de Flandre, CHRU de Lille	Lille
France	Hôpital Fondation Adolphe de Rothschild	Paris
France	Hôpital Necker-Enfants malades	Paris
France	Hopital Robert Debre	Paris
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative duration of hypoxemia expressed in seconds and defined as an arterial oxygen saturation <90%		Up to 15 minutes after anesthesia induction
Secondary	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
Secondary	Lowest recorded value of arterial oxygen saturation.		Up to 15 minutes after anesthesia induction
Secondary	Incidence, expressed as a percentage, of at least one episode of bronchospasm		Up to 15 minutes after anesthesia induction
Secondary	Incidence, expressed as a percentage, of at least one episode of laryngospasm		Up to 15 minutes after anesthesia induction
Secondary	Duration, expressed in seconds, of apnea		Up to 15 minutes after anesthesia induction