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

Primary Purpose

Hypoxemia

Status

Recruiting

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Rocuronium

Sodium chloride 0.9%

About this trial

This is an interventional prevention trial for Hypoxemia

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Intercommunal Creteil (CHIC)
Hôpital Jeanne de Flandre, CHRU de LilleRecruiting
Hôpital Necker-Enfants malades
Hopital Robert DebreRecruiting
Hôpital Fondation Adolphe de RothschildRecruiting
CHU de Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rocuronium

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cumulative duration of hypoxemia expressed in seconds and defined as an arterial oxygen saturation <90%

Cumulative duration, expressed in seconds, with a decreased in arterial oxygen saturation of 5% as compared to the arterial oxygen saturation at baseline

Lowest recorded value of arterial oxygen saturation.

Incidence, expressed as a percentage, of at least one episode of bronchospasm

Incidence, expressed as a percentage, of at least one episode of laryngospasm

Duration, expressed in seconds, of apnea

Full Information

NCT ID

NCT02589691

First Posted

October 27, 2015

Last Updated

July 17, 2023

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

1. Study Identification

Unique Protocol Identification Number

NCT02589691

Brief Title

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

Acronym

ROC-HYPOX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 23, 2015 (Actual)

Primary Completion Date

December 23, 2024 (Anticipated)

Study Completion Date

December 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxemia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

412 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rocuronium

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rocuronium

Intervention Type

Other

Intervention Name(s)

Sodium chloride 0.9%

Primary Outcome Measure Information:

Title

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.

Time Frame