Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant
Condition: Intra-tracheal Intubation
MeSH terms: Muscle Hypotonia
Study type: Interventional
Phase: Phase 3

Summary: 
      REMICrush is a French multicentric non inferiority simple blind randomized clinical trial
      that will compare the use of Remifentanil to muscle relaxant (reference treatment) for
      anesthetic rapid sequence intubation in terms of major complications (difficult intubation,
      gastric liquid aspiration, desaturation, hemodynamics reaction, ventricular arrhythmia,
      anaphylactic reaction).
    

Detailed description: 
      BACKGROUND: Rapid sequence intubation is the reference anaesthetic procedure for patient at
      risk of pulmonary aspiration of gastric contents (for example emergency procedure, bowel
      obstruction, obese patients, gastroesophageal reflux …) or difficult airway management.
      Nowadays the use of Succinylcholine (CELOCURINE), a neuromuscular blockade with a short
      duration of action, is recommended in this indication. However, several adverse events are
      frequently reported, especially anaphylactic reaction, restraining its use for rapid sequence
      intubation. Other adverse effects such as extended neuromuscular block, malignant
      hyperthermia or severe hyperkaliemia prohibit its use. In this case the use of another
      neuromuscular blockade, Rocuronium (ESMERON), is an alternative solution. Unfortunately, this
      other molecule causes as many anaphylactic event as Succinylcholine (1 anaphylactic event for
      3000 uses) and produce a long duration of neuromuscular block. Incidence of anaphylactic
      reaction is increasing in France and mostly severe reactions. Its utilization is therefore
      reduced to 31 to 55% of crush induction despite the recommendations. Remifentanil is an
      opioid agent with very shorts delay and duration of action. Several study have shown similar
      intubation conditions in planned surgery with the use of Remifentanil instead of
      neuromuscular blockade and less hemodynamic reactions. Remifentanil is already approved for
      anesthetic induction and recognized as an alternative to neuromuscular blockade for the
      intubation of children. Use of remifentanil has shown satisfying intubation conditions for
      adults but its incidence of major complications compared to succinylcholine remains unknown.

      Study hypothesis: The investigators thus hypothesized that Remifentanil is non inferior to
      neuromuscular blockade in terms of major complications after a crush induction.

      Methods: A multicenter simple blind randomized controlled trial. 11 centers will participate
      in this project.

      Experimental treatment arm: During anesthetic induction remifentanil will be injected
      immediately after hypnotic drug through bolus intravenous injection by a peripheral or
      verified central venous access, at 3 to 4 µg/kg. Orotracheal intubation will be performed 30
      to 60 seconds later by a graduated anesthesiologist or a resident with 4 validated semesters.

      Control arm treatment: A neuromuscular blockade will be injected right after the hypnotic
      drug. Whether succinylcholine (CELOCURINE) at 1mg/kg or Rocuronium (ESMERON) at 1mg/kg in a
      bolus intravenous injection by a peripheral or verified central venous access. Orotracheal
      intubation will be performed after occurring of fasciculations with succinylcholine or 30 to
      60 seconds after injection of Rocuronium by a graduated anesthesiologist or a resident with 4
      validated semesters.

      Objective and judgment criteria: The primary objective is to demonstrate non inferiority of
      Remifentanil compared to neuromuscular blockade in terms of major complications after a crush
      induction. Primary endpoint is the rate of tracheal intubation without major complications as
      defined by 1/ tracheal intubation with less than 2 laryngoscopies 2/ no aspiration during the
      10 minutes after induction 3/ no desaturation under 95% during the 10 minutes after induction
      4/ no hypo or hypertension as defined by a Median blood pressure<50 mmHg or >110 mmHg 5/ NO
      ventricular arrhythmia involving an emergency treatment or cardiac arrest during the 10
      minutes after induction 6/ No grade III or IV anaphylactic reaction after the 10 minutes
      after induction.

      Statistical analyses:

      A 80% incidence of intubation without major complication was hypothesized. Non inferiority
      has been set under a superior limit of 7% for the primary endpoint 95% of the proportions
      difference between intervention and control group. In order to achieve 80 power with a 5%
      alpha risk, 1150 patients (575 for each arms) are to be included.
    

Intervention name(s): Remifentanil group; neuromuscular blockade group
Intervention type(s): Drug; Drug
Intervention description(s): bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction; Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial in 2 parallel groups assigned to tested drug in intervention group and to reference treatment for control group.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Intubation; Remifentanil; neuromuscular blockade; succinylcholine; Rocuronium; emergency anesthesia; rapid sequence induction