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CompletedNCT01259648Updated Nov 17, 2025

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

A Phase 4 interventional study of 0.5 µg/kg remifentanil and 1.0 µg/kg remifentanil in Tachycardia, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 2 sites in France. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
65 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Tachycardia

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Keywords

  • remifentanil
  • anesthesia induction
  • reactional tachycardia
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In context

Tachycardia

623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.

This study's enrollment of 75 is above the median of 64 across 379 interventional studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • 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

  • 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

  • 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

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

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What researchers measure

Primary outcomes

  1. Cardiac frequency (beats per minute)

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

    Time frame: 15 minutes

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Study locations

2 sites
  • Centre Hospitalier Universitaire de Nîmes
    Nîmes, Gard 30029, France
  • Polyclinique Grand Sud
    Nîmes, Gard 30029, France
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References and documents

Publications

  • Chaumeron A, Castanie J, Fortier LP, Basset P, Bastide S, Alonso S, Lefrant JY, Cuvillon P. Efficacy and safety of remifentanil in a rapid sequence induction in elderly patients: A three-arm parallel, double blind, randomised controlled trial. Anaesth Crit Care Pain Med. 2020 Apr;39(2):215-220. doi: 10.1016/j.accpm.2019.09.010. Epub 2019 Oct 12. PubMed 31614244 ↗

Individual participant data

Plan to share: Yes — Data available upon request.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01259648
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Dec 14, 2010
Start date
Mar 9, 2011
Primary completion
May 20, 2014
Completion
May 20, 2014
Last update
Nov 17, 2025

Study contacts

Arnaud Chaumeron, MD
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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