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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hypoxemia
• Intervention / Treatment: Drug: Rocuronium; Other: Sodium chloride 0.9%

• Study Type: Interventional
• Enrollment (Estimated): 412
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Completed
    • Centre Hospitalier Intercommunal Creteil (CHIC)
  • Lille, France, 59000
    • Recruiting
    • Hôpital Jeanne de Flandre, CHRU de Lille
    • Contact: Francis Veyckemans, Dr; Phone Number: 03 20 4463 23; Email: francis.veyckemans@chru-lille.fr
  • Paris, France, 75019
    • Recruiting
    • Hôpital Robert Debré
    • Contact: Souhayl DAHMANI, Pr; Phone Number: 0140032020; Email: souhayl.dahmani@rdb.aphp.fr
  • Paris, France, 75015
    • Completed
    • Hôpital Necker-Enfants Malades
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation Adolphe de Rothschild
    • Contact: Amélie YAVCHITZ, MD, PhD; Phone Number: +33 1 48 03 64 54; Email: ayavchitz@for.paris
  • Toulouse, France, 31059
    • Completed
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rocuronium; Intra-venous injection during induction anesthesia of 0.3 mg/kg (1 mL/kg) of rocuronium	Drug: Rocuronium
Placebo Comparator: Placebo; Intra-venous injection during induction anesthesia of 1 mL/kg of sodium chloride 0.9%	Other: Sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2015
• Primary Completion (Estimated): December 23, 2024
• Study Completion (Estimated): December 23, 2025

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimated): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: FDE_2014_25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No