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

Centre Hospitalier Universitaire de Nīmes

Status and phase: Completed; Phase 4

Conditions: Tachycardia

Treatments: Drug: NaCl; Drug: 1.0 µg/kg remifentanil; Drug: 0.5 µg/kg remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01259648

LOCAL/2009/AC-02

2009-018169-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

0.5 µg / kg remifentanil

Experimental group

Description:

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

Treatment:

Drug: 0.5 µg/kg remifentanil

1.0 µg/kg remifentanil

Experimental group

Description:

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

Treatment:

Drug: 1.0 µg/kg remifentanil

NaCl

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl