AzTrials
AzTrials

ComaPhase 3CURASMURNCT02000674

Succinylcholine vs Rocuronium for Prehospital Emergency Intubation

A Phase 3 study testing Succinylcholine : 1mg/kg and Rocuronium : 1.2 mg/kg in people with Coma and Major Trauma, run by Centre Hospitalier Universitaire de la Réunion at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included in order to compare the use of succinylcholine vs Rocuronium for prehospital emergency intubation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coma, Major Trauma, Respiratory Distress
What is being tested?
Succinylcholine : 1mg/kg and Rocuronium : 1.2 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,321 participants
Where
17 sitesFrance
Study dates
Dec 2013to Jul 2016
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context

Who cannot join

  • Patients in cardiac arrest;
  • Patients under-18s;
  • Patients under guardianship ;
  • Pregnancy known;
  • Patients with cons to one of the following three drugs: rocuronium, succinylcholine, sugammadex;
  • Patients not affiliated to a social security scheme (beneficiary or legal).

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • CHU Avicenne

    Bobigny

  • CHU Henri Mondor

    Créteil

  • CHU de Dijon

    Dijon

  • CHU Raymond Poincaré

    Garches

  • CH Gonesse

    Gonesse

  • CHRU de Lille

    Lille

  • CH Marc Jacquet

    Melun

  • CHU de Nîmes

    Nîmes

  • CHU Hôtel-Dieu

    Paris

  • CHU Lariboisière

    Paris

  • CHU Necker

    Paris

  • CHU Pitié-Salpêtrière

    Paris

  • CH René Dubos

    Pontoise

  • CH Annecy

    Pringy

  • CHU de La Réunion

    Saint-Denis, La Réunion, 97405

  • CHU de la Réunion

    Saint-Pierre, La Réunion

  • CHU Toulouse - Hôpital PURPAN

    Toulouse

Other trials in France

About this study

Official title: Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial

All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included in order to compare the use of succinylcholine vs Rocuronium for prehospital emergency intubation.

Read the detailed description

All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included. All intubation will be performed by an emergency physician or a nurse specialized in anesthesia. For patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation.

Comparisons studied will be : Intubation success rate at the first laryngoscopy, glottis exposure assessed by Cormack and Lehane classification, difficult intubation rate assessed by the Intubation Difficult Score (IDS), the conditions of intubation assessed by the Copenhagen score, the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.

Being tested
Succinylcholine : 1mg/kg, Rocuronium : 1.2 mg/kg
Keywords
tracheal intubation, pre hospital emergency
Medical subject headings
Coma, Dyspnea, Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Succinylcholine : 1mg/kgDrug

    Also called Suxaméthonium Aguetant®, SUXAMETHONIUM BIOCODEX 50 mg/ml, solution injectable

  • Rocuronium : 1.2 mg/kgDrug

    Also called ESMERON®

Study groups in NCT02000674
Study groupRoleWhat they receive
Administration of SuccinylcholineActive comparatorIntubation after IV administration of Succinylcholine 1mg/kg
Receives: Drug: Succinylcholine : 1mg/kg
Administration of RocuroniumExperimentalIntubation after IV administration of Rocuronium 1.2 mg/kg
Receives: Drug: Rocuronium : 1.2 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First-pass intubation success rate

    Measured by the proportion of successful intubation in the first laryngoscopy.

    Measured: between 1 hour to 3 hours after inclusion

Secondary outcomes (4)

  1. Incidence of difficult intubation

    measured by the Intubation Difficulty Scale

    Measured: between 1 hour to 3 hours after inclusion

  2. Intubation conditions assessment

    using the Copenhagen score

    Measured: between 1 hour to 3 hours after inclusion

  3. Need for alternate airway devices

    Measured: between 1 hour to 3 hours after inclusion

  4. early intubation-related complications

    complications : esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, bronchospasm or laryngospasm, ventricular tachycardia, arterial desaturation, hypotension, or cardiac arrest

    Measured: between 1 hour to 3 hours after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02000674
Sponsor's protocol ID
2013/CHU/05
Other IDs
2013-001438-16
Acronym
CURASMUR
Status last verified
Mar 2017
First submitted
9 Oct 2013
Last updated
15 Dec 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Guihard B, Chollet-Xemard C, Lakhnati P, Vivien B, Broche C, Savary D, Ricard-Hibon A, Marianne Dit Cassou PJ, Adnet F, Wiel E, Deutsch J, Tissier C, Loeb T, Bounes V, Rousseau E, Jabre P, Huiart L, Ferdynus C, Combes X. Effect of Rocuronium vs Succinylcholine on Endotracheal Intubation Success Rate Among Patients Undergoing Out-of-Hospital Rapid Sequence Intubation: A Randomized Clinical Trial. JAMA. 2019 Dec 17;322(23):2303-2312. doi: 10.1001/jama.2019.18254.

    PubMed 31846014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Succinylcholine : 1mg/kg and Rocuronium : 1.2 mg/kg in people with Coma and Major Trauma, run by Centre Hospitalier Universitaire de la Réunion at 17 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 1 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: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First-pass intubation success rate (time frame: between 1 hour to 3 hours after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02000674, which also lists 1 linked publication.

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 15 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in