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Succinylcholine vs Rocuronium for Prehospital Emergency Intubation (CURASMUR)

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ClinicalTrials.gov Identifier: NCT02000674
Recruitment Status : Completed
First Posted : December 4, 2013
Last Update Posted : December 15, 2017
Sponsor:
Collaborators:
Unité de Soutien Méthodologique (CHU de La Réunion)
SAMU de Paris, Hôpital Necker - Enfants Malades
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Brief 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.

Condition or disease Intervention/treatment Phase
Coma Major Trauma Respiratory Distress Shock Drug: Succinylcholine : 1mg/kg Drug: Rocuronium : 1.2 mg/kg Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial
Actual Study Start Date : December 2013
Primary Completion Date : July 2016
Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Administration of Succinylcholine
Intubation after IV administration of Succinylcholine 1mg/kg
Drug: Succinylcholine : 1mg/kg
Other Names:
  • Suxaméthonium Aguetant®
  • SUXAMETHONIUM BIOCODEX 50 mg/ml, solution injectable
Experimental: Administration of Rocuronium
Intubation after IV administration of Rocuronium 1.2 mg/kg
Drug: Rocuronium : 1.2 mg/kg
Other Name: ESMERON®



Primary Outcome Measures :
  1. First-pass intubation success rate [ Time Frame: between 1 hour to 3 hours after inclusion ]
    Measured by the proportion of successful intubation in the first laryngoscopy.


Secondary Outcome Measures :
  1. Incidence of difficult intubation [ Time Frame: between 1 hour to 3 hours after inclusion ]
    measured by the Intubation Difficulty Scale

  2. Intubation conditions assessment [ Time Frame: between 1 hour to 3 hours after inclusion ]
    using the Copenhagen score

  3. Need for alternate airway devices [ Time Frame: between 1 hour to 3 hours after inclusion ]
  4. early intubation-related complications [ Time Frame: between 1 hour to 3 hours after inclusion ]
    complications : esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, bronchospasm or laryngospasm, ventricular tachycardia, arterial desaturation, hypotension, or cardiac arrest



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000674


Locations
France
CHU de La Réunion
Saint Denis, La Réunion, France, 97405
CHU de la Réunion
Saint Pierre, La Réunion, France
CHU Avicenne
Bobigny, France
CHU Henri Mondor
Créteil, France
CHU de Dijon
Dijon, France
CHU Raymond Poincaré
Garches, France
CH Gonesse
Gonesse, France
CHRU de Lille
Lille, France
CH Marc Jacquet
Melun, France
CHU de Nîmes
Nîmes, France
CHU Hôtel-Dieu
Paris, France
CHU Lariboisière
Paris, France
CHU Necker
Paris, France
CHU Pitié-Salpêtrière
Paris, France
CH René Dubos
Pontoise, France
CH Annecy
Pringy, France
CHU Toulouse - Hôpital PURPAN
Toulouse, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Unité de Soutien Méthodologique (CHU de La Réunion)
SAMU de Paris, Hôpital Necker - Enfants Malades
Investigators
Principal Investigator: Xavier Combes, MD CHU de La Réunion

Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT02000674     History of Changes
Other Study ID Numbers: 2013/CHU/05
2013-001438-16 ( EudraCT Number )
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: March 2017

Keywords provided by Centre Hospitalier Universitaire de la Réunion:
tracheal intubation
pre hospital emergency

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Rocuronium
Succinylcholine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neuromuscular Depolarizing Agents