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

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ClinicalTrials.gov Identifier: NCT03960801
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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).

Condition or disease Intervention/treatment Phase
Intra-tracheal Intubation Drug: Remifentanil group Drug: neuromuscular blockade group Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1150 participants
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
Official Title: Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant. A Non-inferiority Simple Blind Randomized Controlled Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remifentanil group
bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction
Drug: Remifentanil group
bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction

Active Comparator: Neuromuscular blockade group
Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction
Drug: neuromuscular blockade group
Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction




Primary Outcome Measures :
  1. Rate of tracheal intubation without major complication [ Time Frame: Day 7 from randomization ]

    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


Secondary Outcome Measures :
  1. quality of intubation: score IDS3 [ Time Frame: At Day 7 ]
    score IDS3 is a composite score for evaluating the difficulty of intubation under laryngoscopy.

  2. level of intubation difficulty [ Time Frame: within 10 minutes ]

    Cormack Lehane score This score describes laryngoscopic views during orotracheal intubation:

    • Cormack 1: The glottis is seen in its entirety
    • Cormack 2: Only the posterior half of the glottis is seen
    • Cormack 3: Only a tiny part of the glottis is seen
    • Cormack 4: The glottis is hidden by the epiglottis and tongue.

  3. Intubation difficulty evaluated by Percentage of opening of the gluteal opening [ Time Frame: within 10 minutes ]

    Evaluated by POGO (Percentage of opening of the gluteal opening) The opening of the orifice is defined by the distance between the anterior and posterior corners of the glottis.

    • A POGO score of 0% means that the glottic opening is not visible.
    • A POGO score of 100% means that the entire glottic gap is visible

  4. use of alternative technic [ Time Frame: within 10 minutes ]
    frequency of alternative technic use

  5. induction-intubation delay [ Time Frame: Within 7 days ]
    delay between hypnotic injection and apparition of the sixth capnographic curve

  6. desaturation [ Time Frame: within 10 minutes ]
    frequency of saturation between 80 et 95% and under 80% following anesthetic induction

  7. severe hemodynamic reaction [ Time Frame: within 10 minutes ]
    proportion of patients with cardiac frequency under 45 or above 110 and / or systolic arterial pressure under 80 mmHg or above 160 mmHg and or mean arterial pressure under 55mmHg or above 100 mmHg during the ten minutes following induction

  8. teeth/ tracheal trauma [ Time Frame: At day 7 ]
    proportion of patient with teeth or tracheal (endoscopic exam) trauma

  9. Allergies [ Time Frame: within 10 minutes ]
    proportion of patients with grade I or II anaphylactic reaction

  10. postoperative sore throat [ Time Frame: 1 hour after extubation ]

    POST grade (postoperative sore throat) is evaluated at 1 h after extubation

    Grade 0 = No pain Grade 1 = Mild pain (complains of pain on request) Grade 2 = Moderate pain (complains of pain spontaneously) Grade 3 = Severe pain (voice change, hoarseness, aphonia)


  11. post operative pneumonia [ Time Frame: At day 7 ]
    proportion of patients who developed pneumonia at day 7 of hospitalization, as defined by new lung infiltration at chest X-ray or tomodensitometry scanner associated with at least one of the following symptom : new purulent expectoration, change of chronic expectorations, fever> 38°C, leukocyte count < 4000/mL or > 12000/mL, positive blood culture and pathogen identification on respiratory sample

  12. Proportion of patients with post-operative respiratory distress [ Time Frame: At day 7 ]
    proportion of patients who developed post-operative respiratory distress within 7 days of hospitalization defined by acute respiratory failure with hypoxemia, PaO2/FiO2 ratio < 300 mmHg, new bilateral infiltrations on chest X-ray without cardiac etiology

  13. In hospital mortality [ Time Frame: At day 7 ]
    proportion of patients who died in hospital



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03960801


Locations
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France
University Hospital Not yet recruiting
Angers, France
Contact: Sigismond LASOCKI         
Principal Investigator: Sigismond LASOCKI         
Military Hospital Not yet recruiting
Brest, France
Contact: Marc DANGUY DES DESERTS         
Principal Investigator: Marc DANGUY DES DESERTS         
University Hospital Not yet recruiting
Brest, France
Contact: Olivier HUET         
Principal Investigator: Olivier HUET         
University Hospital
Grenoble, France
CHD Vendée Not yet recruiting
La Roche-sur-Yon, France
Contact: Mathieu OUDOT         
Principal Investigator: Mathieu OUDOT         
Hospital Not yet recruiting
Le Mans, France
Contact: Charlène LE MOAL         
Principal Investigator: Charlène LE MOAL         
University Hospital Not yet recruiting
Lille, France
Contact: Matthias GAROT         
Principal Investigator: Matthias GAROT         
University Hospital Lyon Sud Not yet recruiting
Lyon, France
Contact: Jean-Stéphane DAVID         
Principal Investigator: Jean-Stéphane DAVID         
Le Confluent Not yet recruiting
Nantes, France
Contact: Nolwenn CHATEL-JOSSE         
Principal Investigator: Nolwenn CHATEL-JOSSE         
University Hospital Not yet recruiting
Nantes, France
Contact: Nicolas GRILLOT         
Principal Investigator: Antoine ROQUILLY         
Hospital Not yet recruiting
Valenciennes, France
Contact: Younes EL AMINE         
Principal Investigator: Younes EL AMINE         
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03960801     History of Changes
Other Study ID Numbers: RC19_0055
2019-000753-31 ( EudraCT Number )
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
Intubation
Remifentanil
neuromuscular blockade
succinylcholine
Rocuronium
emergency anesthesia
rapid sequence induction

Additional relevant MeSH terms:
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Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Remifentanil
Rocuronium
Succinylcholine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Neuromuscular Depolarizing Agents