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

NCT03960801 | Completed Phase 3

• 2 other identifiers: RC19_00552019-000753-31
• Study Type: interventional
• Target: 1,150
• Locations: 1 country
• Sites: 13

Brief 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).

Conditions

Intra-tracheal Intubation

Keywords

Intubation; Remifentanil; neuromuscular blockade; succinylcholine; Rocuronium; emergency anesthesia; rapid sequence induction

Outcome Measures

Primary Outcomes (1)

• Rate of tracheal intubation without major complication

  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 MAP\<50mmHg or \>110mmHg 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 during the 10 minutes after induction

  Day 7 from randomization

Secondary Outcomes (13)

• quality of intubation: score IDS3

  At Day 7

• level of intubation difficulty

  within 10 minutes

• Intubation difficulty evaluated by Percentage of opening of the gluteal opening

  within 10 minutes

• use of alternative technic

  within 10 minutes

• induction-intubation delay

  Within 7 days

Study Arms (2)

Remifentanil group

EXPERIMENTAL

bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction

Drug: Remifentanil group

Neuromuscular blockade group

ACTIVE COMPARATOR

Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction

Drug: neuromuscular blockade group

Interventions

Remifentanil group DRUG

bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction

Remifentanil group

neuromuscular blockade group DRUG

Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction

Neuromuscular blockade group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (13)

University Hospital

Angers, France

Location

Military Hospital

Brest, France

Location

University Hospital

Brest, France

Location

University Hospital

Grenoble, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

Hospital

Le Mans, France

Location

University hospital (SALENGRO hospital)

Lille, France

Location

University Hospital

Lille, France

Location

University Hospital Lyon Sud

Lyon, France

Location

Le Confluent

Nantes, France

Location

University Hospital

Nantes, France

Location

Toulouse University Hospital

Toulouse, France

Location

Hospital

Valenciennes, France

Location

Related Publications (4)

• Auriault C, Tching-Sin M, Biron L, Faurel-Paul E, Flet L. Assessing the carbon footprint of French academic clinical trials using the NIHR method. BMJ Open. 2025 Dec 25;15(12):e111710. doi: 10.1136/bmjopen-2025-111710.

  PMID: 41453779 DERIVED

• Grillot N, Gonzalez V, Deransy R, Rouhani A, Cintrat G, Rooze P, Naux E, Volteau C, Bouras M, Cinotti R, Roquilly A. Post-induction hypotension during rapid sequence intubation in the operating room: A post hoc analysis of the randomized controlled REMICRUSH trial. Anaesth Crit Care Pain Med. 2025 May;44(3):101502. doi: 10.1016/j.accpm.2025.101502. Epub 2025 Mar 12.

  PMID: 40086728 DERIVED

• Grillot N, Lebuffe G, Huet O, Lasocki S, Pichon X, Oudot M, Bruneau N, David JS, Bouzat P, Jobert A, Tching-Sin M, Feuillet F, Cinotti R, Asehnoune K, Roquilly A; Atlanrea Study GroupSociete Francaise d'Anesthesie Reanimation (SFAR) Research Network. Effect of Remifentanil vs Neuromuscular Blockers During Rapid Sequence Intubation on Successful Intubation Without Major Complications Among Patients at Risk of Aspiration: A Randomized Clinical Trial. JAMA. 2023 Jan 3;329(1):28-38. doi: 10.1001/jama.2022.23550.

  PMID: 36594947 DERIVED

• Grillot N, Garot M, Lasocki S, Huet O, Bouzat P, Le Moal C, Oudot M, Chatel-Josse N, El Amine Y, Danguy des Deserts M, Bruneau N, Cinotti R, David JS, Langeron O, Minville V, Tching-Sin M, Faurel-Paul E, Lerebourg C, Flattres-Duchaussoy D, Jobert A, Asehnoune K, Feuillet F, Roquilly A. Assessment of remifentanil for rapid sequence induction and intubation in patients at risk of pulmonary aspiration of gastric contents compared to rapid-onset paralytic agents: study protocol for a non-inferiority simple blind randomized controlled trial (the REMICRUSH study). Trials. 2021 Mar 30;22(1):237. doi: 10.1186/s13063-021-05192-x.

  PMID: 33785069 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial in 2 parallel groups assigned to tested drug in intervention group and to reference treatment for control group.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: October 9, 2019
• Primary Completion: April 22, 2021
• Study Completion: April 22, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)