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

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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Key information

Conditions

Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Universitaire de Nîmes, Nîmes, Gard, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.5 µg/kg remifentanil

Drug

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

1.0 µg/kg remifentanil

Drug

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

NaCl

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

Primary outcomes

Cardiac frequency (beats per minute)

Time frame: 15 minutes

Patient cardiac frequency (beats per minute) at the time of induction

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Dec 14, 2010
Registry last updated: Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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