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

Phase 4

Completed

• Conditions: Tachycardia
• Interventions: Drug: 0.5 µg/kg remifentanil; Drug: 1.0 µg/kg remifentanil; Drug: NaCl

• Registration Number: NCT01259648
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Study Start: 2011-03-09
• Primary Completion: 2014-05-20
• Study Completion: 2014-05-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5 µg / kg remifentanil	0.5 µg/kg remifentanil	Induction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol.
1.0 µg/kg remifentanil	1.0 µg/kg remifentanil	Induction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol.
NaCl	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

Primary Outcome Measures

Name	Time	Method
Cardiac frequency (beats per minute)	15 minutes	Patient cardiac frequency (beats per minute) at the time of induction

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes, Gard, France

Polyclinique Grand Sud; 🇫🇷 Nîmes, Gard, France