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

NCT02589691 | Unknown Phase 4

• 1 other identifier: FDE_2014_25
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 6

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

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Rocuronium

EXPERIMENTAL

Intra-venous injection during induction anesthesia of 0.3 mg/kg (1 mL/kg) of rocuronium

Drug: Rocuronium

Placebo

PLACEBO COMPARATOR

Intra-venous injection during induction anesthesia of 1 mL/kg of sodium chloride 0.9%

Other: Sodium chloride 0.9%

Interventions

Rocuronium DRUG

Rocuronium

Sodium chloride 0.9% OTHER

Placebo

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age \<2 years
• indication of general anesthesia with tracheal intubation
• inhalational induction scheduled
• written informed consent of both parents

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (6)

Centre Hospitalier Intercommunal Creteil (CHIC)

Créteil, 94000, France

COMPLETED

Hôpital Jeanne de Flandre, CHRU de Lille

Lille, 59000, France

RECRUITING

Hôpital Necker-Enfants malades

Paris, 75015, France

COMPLETED

Hopital Robert Debre

Paris, 75019, France

RECRUITING

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

RECRUITING

CHU de Toulouse

Toulouse, 31059, France

COMPLETED

MeSH Terms

Conditions

Hypoxia

Interventions

Rocuronium; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: December 23, 2015
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2025
• Last Updated: July 18, 2023

Record last verified: 2023-03

Locations

FR (6)