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)
Abstract Background Rapid-onset paralytic agents are recommended to achieve muscle relaxation and facilitate tracheal intubation during rapid sequence induction in patients at risk of pulmonary aspiration of gastric contents. However, opioids are frequently used in this setting. The study’s objectiv...
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BMC
2021-03-01
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Series: | Trials |
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Online Access: | https://doi.org/10.1186/s13063-021-05192-x |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Nicolas Grillot Matthias Garot Sigismond Lasocki Olivier Huet Pierre Bouzat Charlène Le Moal Mathieu Oudot Nolwenn Chatel-Josse Younes El Amine Marc Danguy des Déserts Nathalie Bruneau Raphael Cinotti Jean-Stéphane David Olivier Langeron Vincent Minville Martine Tching-Sin Elodie Faurel-Paul Céline Lerebourg Delphine Flattres-Duchaussoy Alexandra Jobert Karim Asehnoune Fanny Feuillet Antoine Roquilly |
spellingShingle |
Nicolas Grillot Matthias Garot Sigismond Lasocki Olivier Huet Pierre Bouzat Charlène Le Moal Mathieu Oudot Nolwenn Chatel-Josse Younes El Amine Marc Danguy des Déserts Nathalie Bruneau Raphael Cinotti Jean-Stéphane David Olivier Langeron Vincent Minville Martine Tching-Sin Elodie Faurel-Paul Céline Lerebourg Delphine Flattres-Duchaussoy Alexandra Jobert Karim Asehnoune Fanny Feuillet Antoine Roquilly 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 Rapid sequence induction Full stomach patient Remifentanil Paralytic agents Succinylcholine Rocuronium |
author_facet |
Nicolas Grillot Matthias Garot Sigismond Lasocki Olivier Huet Pierre Bouzat Charlène Le Moal Mathieu Oudot Nolwenn Chatel-Josse Younes El Amine Marc Danguy des Déserts Nathalie Bruneau Raphael Cinotti Jean-Stéphane David Olivier Langeron Vincent Minville Martine Tching-Sin Elodie Faurel-Paul Céline Lerebourg Delphine Flattres-Duchaussoy Alexandra Jobert Karim Asehnoune Fanny Feuillet Antoine Roquilly |
author_sort |
Nicolas Grillot |
title |
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) |
title_short |
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) |
title_full |
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) |
title_fullStr |
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) |
title_full_unstemmed |
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) |
title_sort |
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) |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2021-03-01 |
description |
Abstract Background Rapid-onset paralytic agents are recommended to achieve muscle relaxation and facilitate tracheal intubation during rapid sequence induction in patients at risk of pulmonary aspiration of gastric contents. However, opioids are frequently used in this setting. The study’s objective is to demonstrate the non-inferiority of remifentanil compared to rapid-onset paralytic agents, in association with an hypnotic drug, for tracheal intubation in patients undergoing procedure under general anesthesia and at risk of pulmonary aspiration of gastric contents. Methods The REMICRUSH (Remifentanil for Rapid Sequence Induction of Anaesthesia) study is a multicenter, single-blinded, non-inferiority randomized controlled trial comparing remifentanil (3 to 4 μg/kg) with rapid-onset paralytic agents (succinylcholine or rocuronium 1 mg/kg) for rapid sequence induction in 1150 adult surgical patients requiring tracheal intubation during general anesthesia. Enrolment started in October 2019 in 15 French anesthesia units. The expected date of the final follow-up is October 2021. The primary outcome is the proportion of successful tracheal intubation without major complications. A non-inferiority margin of 7% was chosen. Analyses of the intent-to-treat and per-protocol populations are planned. Discussion The REMICRUSH trial protocol has been approved by the ethics committee of The Comité de Protection des Personnes Sud-Ouest et Outre-Mer II and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. The REMICRUSH trial is the first randomized controlled trial powered to investigate whether remifentanil with hypnotics is non-inferior to rapid-onset paralytic agents with hypnotic in rapid sequence induction of anesthesia for full stomach patients considering successful tracheal intubation without major complication. Trial registration ClinicalTrials.gov NCT03960801. Registered on May 23, 2019. |
topic |
Rapid sequence induction Full stomach patient Remifentanil Paralytic agents Succinylcholine Rocuronium |
url |
https://doi.org/10.1186/s13063-021-05192-x |
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doaj-8f33332ce790428f983215da343880912021-04-04T11:29:40ZengBMCTrials1745-62152021-03-0122111010.1186/s13063-021-05192-xAssessment 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)Nicolas Grillot0Matthias Garot1Sigismond Lasocki2Olivier Huet3Pierre Bouzat4Charlène Le Moal5Mathieu Oudot6Nolwenn Chatel-Josse7Younes El Amine8Marc Danguy des Déserts9Nathalie Bruneau10Raphael Cinotti11Jean-Stéphane David12Olivier Langeron13Vincent Minville14Martine Tching-Sin15Elodie Faurel-Paul16Céline Lerebourg17Delphine Flattres-Duchaussoy18Alexandra Jobert19Karim Asehnoune20Fanny Feuillet21Antoine Roquilly22Université de Nantes, CHU Nantes, Pôle Anesthésie-Réanimation, Service d’Anesthésie Réanimation Chirurgicale, Hôtel DieuCHU de Lille, Pole Anesthésie Réanimation, Hôpital Claude HuriezUniversité d’Angers, CHU d’Angers, Département Anesthésie RéanimationAnaesthesia, and Intensive Care Unit, Brest Regional University HospitalPôle d’Anesthésie-Réanimation, Hôpital Albert MichallonAnaesthesia and Intensive Care Unit, Le Mans Public HospitalAnaesthesia Unit, Vendée District Hospital CenterAnaesthesia Unit, Le Confluent Private HospitalAnaesthesia Unit, Valenciennes Public HospitalAnaesthesia and Intensive Care Unit, Clermont-Tonnerre Military HospitalAnaesthesia and Intensive Care Unit, Lille Regional University HospitalCHU Nantes, Pôle Anesthésie-Réanimation, Service d’Anesthésie Réanimation Chirurgicale, Hôpital Guillaume et René Laennec, Université de NantesHospices Civils de Lyon, Lyon Sud Regional University Hospital, Anaesthesia and Intensive Care UnitAnaesthesia and Intensive Care Unit, Henri-Mondor University Hospital (AP-HP)Anaesthesia and Intensive Care Unit, Toulouse University HospitalDepartment of Pharmacy, Nantes University HospitalDepartment of Clinical Research, Nantes University HospitalUniversité de Nantes, CHU Nantes, Pôle Anesthésie-Réanimation, Service d’Anesthésie Réanimation Chirurgicale, Hôtel DieuUniversité de Nantes, CHU Nantes, Pôle Anesthésie-Réanimation, Service d’Anesthésie Réanimation Chirurgicale, Hôtel DieuDepartment of Clinical Research, Nantes University HospitalUniversité de Nantes, CHU Nantes, Pôle Anesthésie-Réanimation, Service d’Anesthésie Réanimation Chirurgicale, Hôtel DieuNantes University Hospital, Methodology and Biostatistics Platform, Department of Clinical ResearchUniversité de Nantes, CHU Nantes, Pôle Anesthésie-Réanimation, Service d’Anesthésie Réanimation Chirurgicale, Hôtel DieuAbstract Background Rapid-onset paralytic agents are recommended to achieve muscle relaxation and facilitate tracheal intubation during rapid sequence induction in patients at risk of pulmonary aspiration of gastric contents. However, opioids are frequently used in this setting. The study’s objective is to demonstrate the non-inferiority of remifentanil compared to rapid-onset paralytic agents, in association with an hypnotic drug, for tracheal intubation in patients undergoing procedure under general anesthesia and at risk of pulmonary aspiration of gastric contents. Methods The REMICRUSH (Remifentanil for Rapid Sequence Induction of Anaesthesia) study is a multicenter, single-blinded, non-inferiority randomized controlled trial comparing remifentanil (3 to 4 μg/kg) with rapid-onset paralytic agents (succinylcholine or rocuronium 1 mg/kg) for rapid sequence induction in 1150 adult surgical patients requiring tracheal intubation during general anesthesia. Enrolment started in October 2019 in 15 French anesthesia units. The expected date of the final follow-up is October 2021. The primary outcome is the proportion of successful tracheal intubation without major complications. A non-inferiority margin of 7% was chosen. Analyses of the intent-to-treat and per-protocol populations are planned. Discussion The REMICRUSH trial protocol has been approved by the ethics committee of The Comité de Protection des Personnes Sud-Ouest et Outre-Mer II and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. The REMICRUSH trial is the first randomized controlled trial powered to investigate whether remifentanil with hypnotics is non-inferior to rapid-onset paralytic agents with hypnotic in rapid sequence induction of anesthesia for full stomach patients considering successful tracheal intubation without major complication. Trial registration ClinicalTrials.gov NCT03960801. Registered on May 23, 2019.https://doi.org/10.1186/s13063-021-05192-xRapid sequence inductionFull stomach patientRemifentanilParalytic agentsSuccinylcholineRocuronium |