Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects

Study Overview
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Brief Summary
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The primary objective is to determine whether, during a rapid sequence intubation by etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2 different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous reactional tachycardia.

Official Title
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Randomized Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects

Conditions
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Tachycardia

Intervention / Treatment
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* Drug: 0.5 µg/kg remifentanil
* Drug: 1.0 µg/kg remifentanil
* Drug: NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring rapid sequence intubation for whatever reason. This includes the following: a full stomach, obesity, diabetic gastroparesis, gastroesophageal reflux Patient able to give informed consent, and sign the consent. Exclusion Criteria: Contraindication for the use of any drugs used (regardless of the patient group): a history of serious side effects, allergic reaction Morbid obesity (Body Mass Index > 40) Emergency situation with unstable hemodynamics, and stabilization is impossible before induction Inclusion in another research project within the past 3 months The patient is not insured or beneficiary of a health insurance plan (for the French centers) Patient under guardianship of any kind Patient unable to give informed consent Refusal to sign the consent form

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5 µg / kg remifentanil<br>Induction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol. | Drug: 0.5 µg/kg remifentanil<br>* 0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol<br>|
| Experimental: 1.0 µg/kg remifentanil<br>Induction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol. | Drug: 1.0 µg/kg remifentanil<br>* 1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol<br>|
| Placebo Comparator: NaCl<br>An equivalent volume (1 ml for 10 kg of weight) of isotonic 0.9% NaCl is injected in addition to the classic anesthesia induction protocol | Drug: NaCl<br>* an equivalent volume (1 ml for 10 kg of weight) of 0.9% isotonic NaCl is injected in addition to the classic anesthesia induction protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac frequency (beats per minute) | Patient cardiac frequency (beats per minute) at the time of induction | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remifentanil, anesthesia induction, reactional tachycardia