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

November 14, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

Randomized 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Gard
      • Nîmes, Gard, France, 30029
        • Centre Hospitalier Universitaire de Nîmes
      • Nîmes, Gard, France, 30029
        • Polyclinique Grand Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.5 µg / kg remifentanil
Induction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol.
Drug: 0.5 µg/kg remifentanil
0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol
Experimental: 1.0 µg/kg remifentanil
Induction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol.
Drug: 1.0 µg/kg remifentanil
1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol
Placebo Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Arnaud Chaumeron, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2011

Primary Completion (Actual)

May 20, 2014

Study Completion (Actual)

May 20, 2014

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimated)

December 14, 2010

Study Record Updates

Last Update Posted (Estimated)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2009/AC-02
  • 2009-018169-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data available upon request.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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