Addition of neuromuscular-blocking agents during induction in infants: potential interest in reducing episodes of oxygen decrease in blood

Addition of neuromuscular-blocking agents during induction in infants: potential interest in reducing hypoxia episodes - ROC-HYPOX

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001668-21-FR

Enrollment

412

Registered

2024-07-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chirurgie programmée sous anesthésie générale avec intubation orotrachéale, avec induction inhalatoire prévue MedDRA version: 21.0 Level: LLT Classification code 10002326 Term: Anesthetic induction System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: ESMERON Pharmaceutical Form: Solution for injection INN or Proposed INN: ROCURONIUM BROMIDE Other descriptive name: ROCURONIUM BROMIDE Concentration unit: mg/ml milligram(s)/millilitre Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Contraindication to: . inhalation induction (stomach full) . the use of rocuronium (intubating scheduled difficult, documented allergy ...) - ASA III or IV - Intracranial surgery - parental refusal - no affiliation to French public wellfare system

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate that adding rocuronium (0,3 mg.kg-1) to the sevoflurane-6 % and sufentanil 0,1 mcg.kg-1 anaesthetic protocole reduces the incidence of hypoxemia while intubating infants aged 1-24 months;Secondary Objective: Search the impact of curare administration on the incidence of respiratory events (bronchospasm, laryngospasm, prolonged apnea duration) Search link between intubating conditions (assessed by the score of Copenhagen) and incidence, intensity and duration of hypoxemia, as well as the occurrence of respiratory events;Primary end point(s): Incidence rate of hypoxemia, defined as a blood oxygen saturation <90%, obtained by continuous measurement of pulse oximetry (SpO2) at any time between the injection of rocuronium or placebo and 5 minutes after completion intubation;Timepoint(s) of evaluation of this end point: At any time between the injection of rocuronium or placebo and 5 minutes after completion intubation ( paritcipation time = 1 hour)	—

Measure

Time frame

Main Objective: Demonstrate that adding rocuronium (0,3 mg.kg-1) to the sevoflurane-6 % and sufentanil 0,1 mcg.kg-1 anaesthetic protocole reduces the incidence of hypoxemia while intubating infants aged 1-24 months;Secondary Objective: Search the impact of curare administration on the incidence of respiratory events (bronchospasm, laryngospasm, prolonged apnea duration) Search link between intubating conditions (assessed by the score of Copenhagen) and incidence, intensity and duration of hypoxemia, as well as the occurrence of respiratory events;Primary end point(s): Incidence rate of hypoxemia, defined as a blood oxygen saturation <90%, obtained by continuous measurement of pulse oximetry (SpO2) at any time between the injection of rocuronium or placebo and 5 minutes after completion intubation;Timepoint(s) of evaluation of this end point: At any time between the injection of rocuronium or placebo and 5 minutes after completion intubation ( paritcipation time = 1 hour)

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Secondary

Measure	Time frame
Secondary end point(s): 1 / respiratory events: . cumulative duration of hypoxemia (time with SpO2 30% of the heart rate and mean arterial pressure 4 / incidence of residual paralysis (monitoring by train 4 to the adductor inch) 5 / incidence of pharmacological reversal necessitated by residual paralysis;Timepoint(s) of evaluation of this end point: At any time between the injection of rocuronium or placebo and 5 minutes after completion intubation ( paritcipation time = 1 hour)	—

Measure

Time frame

Secondary end point(s): 1 / respiratory events: . cumulative duration of hypoxemia (time with SpO2 30% of the heart rate and mean arterial pressure 4 / incidence of residual paralysis (monitoring by train 4 to the adductor inch) 5 / incidence of pharmacological reversal necessitated by residual paralysis;Timepoint(s) of evaluation of this end point: At any time between the injection of rocuronium or placebo and 5 minutes after completion intubation ( paritcipation time = 1 hour)

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Countries

France

Contacts

Public ContactUnité de Recherche Clinique

Fondation Ophtalmologique A. de Rothschild

lsalomon@fo-rothschild.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026