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

Phase 4

Recruiting

• Conditions: Hypoxemia
• Interventions: Other: Sodium chloride 0.9%; Drug: Rocuronium

• Registration Number: NCT02589691
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2015-12-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18
• Primary Completion: 2024-12-23
• Study Completion: 2025-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 412

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Sodium chloride 0.9%	Intra-venous injection during induction anesthesia of 1 mL/kg of sodium chloride 0.9%
Rocuronium	Rocuronium	Intra-venous injection during induction anesthesia of 0.3 mg/kg (1 mL/kg) of rocuronium

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Duration, expressed in seconds, of apnea	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

Trial Locations

Locations (6)

Hôpital Fondation Adolphe de Rothschild; 🇫🇷 Paris, France

Hopital Robert Debre; 🇫🇷 Paris, France

Centre Hospitalier Intercommunal Creteil (CHIC); 🇫🇷 Créteil, France

Hôpital Necker-Enfants malades; 🇫🇷 Paris, France

CHU de Toulouse; 🇫🇷 Toulouse, France

Hôpital Jeanne de Flandre, CHRU de Lille; 🇫🇷 Lille, France