HypoxemiaPhase 4ROC-HYPOXNCT02589691
Neuromuscular-Blocking Agents and Hypoxemia During Intubation in Infants (ROC-HYPOX)
A Phase 4 study testing Rocuronium and Sodium chloride 0.9% in people with Hypoxemia, run by Fondation Ophtalmologique Adolphe de Rothschild at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Rocuronium and Sodium chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 412 participants
- Where
- 6 sitesFrance
- Study dates
- 23 Dec 2015to 23 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age <2 years
- indication of general anesthesia with tracheal intubation
- inhalational induction scheduled
- written informed consent of both parents
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 3 recruiting
- Completed
Centre Hospitalier Intercommunal Creteil (CHIC)
Créteil, 94000
- Recruiting
Hôpital Jeanne de Flandre, CHRU de Lille
Lille, 59000
Francis Veyckemans, Dr, 03 20 4463 23, francis.veyckemans@chru-lille.fr
- Completed
Hôpital Necker-Enfants malades
Paris, 75015
- Recruiting
Hopital Robert Debre
Paris, 75019
Souhayl DAHMANI, Pr, 0140032020, souhayl.dahmani@rdb.aphp.fr
- Recruiting
Hôpital Fondation Adolphe de Rothschild
Paris, 75019
Amélie YAVCHITZ, MD, PhD, +33 1 48 03 64 54, ayavchitz@for.paris
- Completed
CHU de Toulouse
Toulouse, 31059
About this study
Official title: 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
- Conditions
- Hypoxemia
- Being tested
- Rocuronium, Sodium chloride 0.9%
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Sodium chloride 0.9%Other
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium | Experimental | Intra-venous injection during induction anesthesia of 0.3 mg/kg (1 mL/kg) of rocuronium Receives: Drug: Rocuronium |
| Placebo | Placebo comparator | Intra-venous injection during induction anesthesia of 1 mL/kg of sodium chloride 0.9% Receives: Other: Sodium chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%
Measured: 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
Measured: Up to 15 minutes after anesthesia induction
Lowest recorded value of arterial oxygen saturation.
Measured: Up to 15 minutes after anesthesia induction
Incidence, expressed as a percentage, of at least one episode of bronchospasm
Measured: Up to 15 minutes after anesthesia induction
Incidence, expressed as a percentage, of at least one episode of laryngospasm
Measured: Up to 15 minutes after anesthesia induction
Duration, expressed in seconds, of apnea
Measured: Up to 15 minutes after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start23 Dec 2015
- Primary completion23 Dec 2024 (estimated)
- Study completion23 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589691
- Sponsor's protocol ID
- FDE_2014_25
- Acronym
- ROC-HYPOX
- Status last verified
- Mar 2023
- First submitted
- 27 Oct 2015
- Last updated
- 18 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Neuromuscular-Blocking Agents During Sevoflurane Induction in Infants : Potential Interest in Reducing Hypoxemia Episodes
- ClinicalTrials.gov ID
- NCT02589691
- Acronym / sponsor ID
- ROC-HYPOX / FDE_2014_25
- Conditions
- Hypoxemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 23 Dec 2015 (actual)
- Primary completion
- 23 Dec 2024 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium | Experimental | Drug: RocuroniumIntra-venous injection during induction anesthesia of 0.3 mg/kg (1 mL/kg) of rocuronium |
| Placebo | Placebo comparator | Other: Sodium chloride 0.9%Intra-venous injection during induction anesthesia of 1 mL/kg of sodium chloride 0.9% |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age <2 years
- indication of general anesthesia with tracheal intubation
- inhalational induction scheduled
- written informed consent of both parents
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuronium | Drug | Rocuronium |
| Sodium chloride 0.9% | Other | Placebo |
Primary outcome
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: Up to 15 minutes after anesthesia induction
6 secondary outcomes
Cumulative duration of hypoxemia expressed in seconds and defined as an arterial oxygen saturation <90%
Time frame: 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
Time frame: Up to 15 minutes after anesthesia induction
Lowest recorded value of arterial oxygen saturation.
Time frame: Up to 15 minutes after anesthesia induction
Incidence, expressed as a percentage, of at least one episode of bronchospasm
Time frame: Up to 15 minutes after anesthesia induction
Incidence, expressed as a percentage, of at least one episode of laryngospasm
Time frame: Up to 15 minutes after anesthesia induction
Duration, expressed in seconds, of apnea
Time frame: Up to 15 minutes after anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium and Sodium chloride 0.9% in people with Hypoxemia, run by Fondation Ophtalmologique Adolphe de Rothschild at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: Up to 15 minutes after anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.