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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-09

Study Completion Date

2014-05-20

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.

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Detailed Description

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Conditions

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Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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0.5 µg / kg remifentanil

Induction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol.

Group Type EXPERIMENTAL

0.5 µg/kg remifentanil

Intervention Type DRUG

0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol

1.0 µg/kg remifentanil

Induction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol.

Group Type EXPERIMENTAL

1.0 µg/kg remifentanil

Intervention Type DRUG

1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol

NaCl

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

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type DRUG

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

Interventions

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0.5 µg/kg remifentanil

0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol

Intervention Type DRUG

1.0 µg/kg remifentanil

1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol

Intervention Type DRUG

NaCl

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

Intervention Type DRUG

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No