Clinical Trial Results:
Evaluation of REMIFENTANIL as an alternative to curare for rapid sequence anesthetic induction in patients at risk of gastric fluid inhalation
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Summary
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EudraCT number |
2019-000753-31 |
Trial protocol |
FR |
Global end of trial date |
22 Apr 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Sep 2022
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First version publication date |
08 Sep 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RC19_0055
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03960801 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
CHU NANTES
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Sponsor organisation address |
5 allée de l'ile gloriette, NANTES, France,
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Public contact |
Direction de la Recherche, CHU NANTES, 33 25348283533, bp-prom-reg@chu-nantes.fr
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Scientific contact |
Direction de la Recherche, CHU NANTES, 33 25348283533, bp-prom-reg@chu-nantes.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Apr 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Apr 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the study is to demonstrate the non-inferiority of a rapid sequence anesthetic induction without curare with remifentanil on the prevention of major complications related to tracheal intubation compared to a rapid sequence induction with curare of short duration of action.
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Protection of trial subjects |
The investigators are responsible for obtaining the written free and informed consent of the patient, after having provided him/her with information about the protocol .In case of impossibility for the investigators to deliver clear and loyal information to the patient within the maximum time of inclusion of the study (e.g.: urgent surgical procedure, polytrauma, confusional state), an emergency procedure was available to the investigator in order to support the inclusion of the patient without delaying the medical-surgical management
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Oct 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 1150
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Worldwide total number of subjects |
1150
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EEA total number of subjects |
1150
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
840
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From 65 to 84 years |
308
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85 years and over |
2
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Recruitment
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Recruitment details |
The study population was composed of adult hospitalized patients requiring rapid sequence induction in the operating room or in the dechoking room. Participation in the study was proposed to the patient during the preoperative anaesthesia consultation by the anaesthesiologist-intensive care physician, with the presentation of the information not | |||||||||
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Pre-assignment
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Screening details |
Subjects were included in few french hospital | |||||||||
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Period 1
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Period 1 title |
Period 1 (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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REMIFENTANIL | |||||||||
Arm description |
Injection of remifentanil (3 to 4µg/kg) immediately after the injection of a hypnotic | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
REMIFENTANIL
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for injection
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
Injection of remifentanil (3 to 4µg/kg) immediately after the injection of a hypnotic
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Arm title
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MYORELAXANT | |||||||||
Arm description |
injection of rocuronium bromide or suxamethonium chloride | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
SUXAMETHONIUM CHLORIDE
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Investigational medicinal product code |
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Other name |
succinylcholine
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Pharmaceutical forms |
Powder for injection
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
a rapid onset paralytic agent (1 mg/kg of succinylcholine was intravenously injected immediately after
administering a hypnotic, and the tracheal intubation was initiated 30 to 60 seconds after
administration of the myorelaxant. Succinylcholine was the myorelaxant first choice and
rocuronium was recommended in case of counterindication of the use of succinylcholine. No
morphine derivates should be injected before the first intubation attempt.
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Investigational medicinal product name |
ROCURONIUM CHLORIDE
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for injection
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
a rapid onset paralytic agent (1 mg/kg of rocuronium ) was intravenously injected immediately after
administering a hypnotic, and the tracheal intubation was initiated 30 to 60 seconds after
administration of the myorelaxant. Succinylcholine was the myorelaxant first choice and
rocuronium was recommended in case of counterindication of the use of succinylcholine. No
morphine derivates should be injected before the first intubation attempt.
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Baseline characteristics reporting groups
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Reporting group title |
Period 1
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Reporting group description |
- | |||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Analysis ITT
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||
Subject analysis set description |
From October 2019 to April 2021, 1150 patients underwent randomization (egal ITT population) and were followed up for seven days (575 patients in the remifentanil group and 575 in the myorelaxant group).
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End points reporting groups
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Reporting group title |
REMIFENTANIL
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Reporting group description |
Injection of remifentanil (3 to 4µg/kg) immediately after the injection of a hypnotic | ||
Reporting group title |
MYORELAXANT
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Reporting group description |
injection of rocuronium bromide or suxamethonium chloride | ||
Subject analysis set title |
Analysis ITT
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
From October 2019 to April 2021, 1150 patients underwent randomization (egal ITT population) and were followed up for seven days (575 patients in the remifentanil group and 575 in the myorelaxant group).
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End point title |
successful tracheal intubation without major complications | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
within 10 min after intubation
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Statistical analysis title |
ITT analysis | ||||||||||||
Comparison groups |
MYORELAXANT v REMIFENTANIL
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Number of subjects included in analysis |
1136
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
Method |
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Parameter type |
Proportion difference | ||||||||||||
Point estimate |
-6.1
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-11.7 | ||||||||||||
upper limit |
-0.6 | ||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
until end of hospitalization
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24
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Reporting groups
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Reporting group title |
All patients randomized
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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06 Feb 2020 |
Modification of investigator list
Modification of inclusion criteria
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10 Sep 2020 |
change in manufacturer of remifentanil |
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03 Dec 2020 |
Change in investigator list
Change in statistical analysis part |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
