Succinylcholine vs Rocuronium for Prehospital Emergency Intubation (CURASMUR)

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.

Study Overview

• Status: Completed
• Conditions: Shock; Coma; Major Trauma; Respiratory Distress
• Intervention / Treatment: Drug: Succinylcholine : 1mg/kg; Drug: Rocuronium : 1.2 mg/kg

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
• Enrollment (Actual): 1321
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bobigny, France
    • CHU Avicenne
  • Créteil, France
    • CHU Henri Mondor
  • Dijon, France
    • CHU de Dijon
  • Garches, France
    • CHU Raymond Poincare
  • Gonesse, France
    • CH Gonesse
  • Lille, France
    • CHRU de Lille
  • Melun, France
    • CH Marc Jacquet
  • Nîmes, France
    • CHU de Nimes
  • Paris, France
    • CHU Lariboisière
  • Paris, France
    • CHU Hôtel-Dieu
  • Paris, France
    • CHU Necker
  • Paris, France
    • CHU Pitié-Salpêtrière
  • Pontoise, France
    • CH René Dubos
  • Pringy, France
    • CH Annecy
  • Toulouse, France
    • Chu Toulouse - Hopital Purpan
  • La Réunion
    • Saint Denis, La Réunion, France, 97405
      • CHU de la Réunion
    • Saint Pierre, La Réunion, France
      • CHU de la Réunion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: ESMERON®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-pass intubation success rate	Measured by the proportion of successful intubation in the first laryngoscopy.	between 1 hour to 3 hours after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of difficult intubation	measured by the Intubation Difficulty Scale	between 1 hour to 3 hours after inclusion
Intubation conditions assessment	using the Copenhagen score	between 1 hour to 3 hours after inclusion
Need for alternate airway devices		between 1 hour to 3 hours after inclusion
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	between 1 hour to 3 hours after inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Collaborators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2013
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (ESTIMATE): December 4, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: tracheal intubation; pre hospital emergency
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Rocuronium; Succinylcholine
• Other Study ID Numbers: 2013/CHU/05; 2013-001438-16 (EUDRACT_NUMBER)