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

NCT01259648 | Completed Phase 4

• 2 other identifiers: LOCAL/2009/AC-022009-018169-12
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Tachycardia

Keywords

remifentanil; anesthesia induction; reactional tachycardia

Outcome Measures

Primary Outcomes (1)

• Cardiac frequency (beats per minute)

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

  15 minutes

Study Arms (3)

0.5 µg / kg remifentanil

EXPERIMENTAL

Induction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol.

Drug: 0.5 µg/kg remifentanil

1.0 µg/kg remifentanil

EXPERIMENTAL

Induction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol.

Drug: 1.0 µg/kg remifentanil

NaCl

PLACEBO COMPARATOR

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

0.5 µg/kg remifentanil DRUG

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

0.5 µg / kg remifentanil

1.0 µg/kg remifentanil DRUG

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

1.0 µg/kg remifentanil

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

NaCl

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

Polyclinique Grand Sud

Nîmes, Gard, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 31614244 RESULT

MeSH Terms

Conditions

Tachycardia

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Arnaud Chaumeron, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 14, 2010
• Study Start: March 9, 2011
• Primary Completion: May 20, 2014
• Study Completion: May 20, 2014
• Last Updated: November 17, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (2)