Intra-tracheal IntubationPhase 3REMICRUSHNCT03960801
Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant
A Phase 3 study testing Remifentanil group and neuromuscular blockade group in people with Intra-tracheal Intubation, run by Nantes University Hospital at 13 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intra-tracheal Intubation
- What is being tested?
- Remifentanil group and neuromuscular blockade group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 13 sitesFrance
- Study dates
- 9 Oct 2019to 22 Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- 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%)
Show all 11Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
University Hospital
Angers
Military Hospital
Brest
University Hospital
Brest
University Hospital
Grenoble
CHD Vendée
La Roche-sur-Yon
Hospital
Le Mans
University hospital (SALENGRO hospital)
Lille
University Hospital
Lille
University Hospital Lyon Sud
Lyon
Le Confluent
Nantes
University Hospital
Nantes
Toulouse University Hospital
Toulouse
Hospital
Valenciennes
About this study
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
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).
Read the 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.
- Conditions
- Intra-tracheal Intubation
- Being tested
- Remifentanil group, neuromuscular blockade group
- Keywords
- Intubation, Remifentanil, neuromuscular blockade, succinylcholine, Rocuronium, emergency anesthesia, rapid sequence induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil groupDrug
bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction
neuromuscular blockade groupDrug
Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil group | Experimental | bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction Receives: 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 Receives: Drug: neuromuscular blockade group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tracheal intubation without major complication
Primary endpoint is the rate of tracheal intubation without major complications as defined by
- tracheal intubation with less than 2 laryngoscopies
- no aspiration during the 10 minutes after induction
- no desaturation under 95% during the 10 minutes after induction
- no hypo or hypertension as defined by a MAP<50mmHg or >110mmHg
- no ventricular arrhythmia involving an emergency treatment or cardiac arrest during the 10 minutes after induction
- no grade III or IV anaphylactic reaction during the 10 minutes after induction
Measured: Day 7 from randomization
Secondary outcomes (13)
quality of intubation: score IDS3
score IDS3 is a composite score for evaluating the difficulty of intubation under laryngoscopy.
Measured: At Day 7
level of intubation difficulty
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.
Measured: within 10 minutes
Intubation difficulty evaluated by Percentage of opening of the gluteal opening
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
Measured: within 10 minutes
use of alternative technic
frequency of alternative technic use
Measured: within 10 minutes
induction-intubation delay
delay between hypnotic injection and apparition of the sixth capnographic curve
Measured: Within 7 days
desaturation
frequency of saturation between 80 et 95% and under 80% following anesthetic induction
Measured: within 10 minutes
severe hemodynamic reaction
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
Measured: within 10 minutes
teeth/ tracheal trauma
proportion of patient with teeth or tracheal (endoscopic exam) trauma
Measured: At day 7
Allergies
proportion of patients with grade I or II anaphylactic reaction
Measured: within 10 minutes
postoperative sore throat
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)
Measured: 1 hour after extubation
post operative pneumonia
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
Measured: At day 7
Proportion of patients with post-operative respiratory distress
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
Measured: At day 7
In hospital mortality
proportion of patients who died in hospital
Measured: At day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start9 Oct 2019
- Primary completion22 Apr 2021
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intra-tracheal IntubationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960801
- Sponsor's protocol ID
- RC19_0055
- Other IDs
- 2019-000753-31, 2019
- Acronym
- REMICRUSH
- Status last verified
- Apr 2021
- First submitted
- 21 May 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41453779Grillot 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.
PubMed 40086728Grillot 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.
PubMed 36594947Grillot 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.
PubMed 33785069
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03960801
- Acronym / sponsor ID
- REMICRUSH / RC19_0055
- Conditions
- Intra-tracheal Intubation
- Keywords
- Intubation, Remifentanil, neuromuscular blockade, succinylcholine, Rocuronium, emergency anesthesia, rapid sequence induction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial in 2 parallel groups assigned to tested drug in intervention group and to reference treatment for control group.
| Arm | Type | Receives |
|---|---|---|
| Remifentanil group | Experimental | Drug: Remifentanil groupbolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction |
| Neuromuscular blockade group | Active comparator | Drug: neuromuscular blockade groupBolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remifentanil groupbolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction | Drug | Remifentanil group |
| neuromuscular blockade groupBolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction | Drug | Neuromuscular blockade group |
Primary outcome
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
13 secondary outcomes
quality of intubation: score IDS3
Time frame: At Day 7
level of intubation difficulty
Time frame: within 10 minutes
Intubation difficulty evaluated by Percentage of opening of the gluteal opening
Time frame: within 10 minutes
use of alternative technic
Time frame: within 10 minutes
induction-intubation delay
Time frame: Within 7 days
desaturation
Time frame: within 10 minutes
severe hemodynamic reaction
Time frame: within 10 minutes
teeth/ tracheal trauma
Time frame: At day 7
Allergies
Time frame: within 10 minutes
postoperative sore throat
Time frame: 1 hour after extubation
post operative pneumonia
Time frame: At day 7
Proportion of patients with post-operative respiratory distress
Time frame: At day 7
In hospital mortality
Time frame: At day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 41453779Auriault 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.
- Derived from this study: PubMed 40086728Grillot 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.
- Derived from this study: PubMed 36594947Grillot 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.
- Derived from this study: PubMed 33785069Grillot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remifentanil group and neuromuscular blockade group in people with Intra-tracheal Intubation, run by Nantes University Hospital at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of tracheal intubation without major complication (time frame: Day 7 from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03960801, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.