Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant

• Status: Completed
• Trial end date: 2021-04-22
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Anesthetics; Hypnotics and Sedatives; Remifentanil; Rocuronium; Succinylcholine

Criteria

Inclusion Criteria:

• - male or female

• aged from 18 to 80 years old

• surgery requiring general anaesthesia with tracheal with oro-tracheal intubation

• Rapid sequence intubation indication

• aspiration risk defined as : fasting < 6h00, digestive occlusion, functional ileus, vomiting < 12h00, orthopaedic trauma < 12h00, severe gastric reflux, gastroparesis and/or dysautonomia and or gastro-oesophagus surgery

• signed informed consent sheet ; or emergency procedure if impossible

Exclusion Criteria:

• planned impossible intubation

• suspected/known allergy to neuromuscular blockade or remifentanil

• Neuromuscular disease forbidding neuromuscular blockade use

• Prolonged neuromuscular block former episode

• Malignant hyperthermia former episode

• Pre-operative respiratory failure (spO2< 95%)

• Pre-operative hemodynamic failure (use of vasopressor)

• cardiac arrest

• A woman of childbearing age who has an active pregnancy and/or clinical signs suggestive of an active pregnancy and/or does not have a contraceptive or contraceptive method and has had unprotected sex within 15 days of the last menstrual period.

• Patients under justice protection

• Use of etomidate for anesthetic induction