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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01259648

Enrollment

Registered

2010-12-14

Start date

2011-03-09

Completion date

2014-05-20

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tachycardia

Keywords

remifentanil, anesthesia induction, reactional tachycardia

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.

Interventions

DRUG0.5 µg/kg remifentanil

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

DRUG1.0 µg/kg remifentanil

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

DRUGNaCl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiac frequency (beats per minute)	15 minutes	Patient cardiac frequency (beats per minute) at the time of induction

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026