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

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01259648
First received: December 13, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Tachycardia
Drug: 0.5 µg/kg remifentanil
Drug: 1.0 µg/kg remifentanil
Drug: NaCl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Cardiac frequency (beats per minute) [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
    Patient cardiac frequency (beats per minute) at the time of induction


Estimated Enrollment: 75
Study Start Date: March 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259648

Contacts
Contact: Arnaud M Chaumeron, Md +33.4.66.68.30.50 arnaud.chaumeron@orange.fr
Contact: Carey M Suehs 3466686788 carey.suehs@chu-nimes.fr

Locations
France
Centre Hospitalier Universitaire de Nîmes Recruiting
Nîmes, Gard, France, 30029
Principal Investigator: Arnaud Chaumeron, MD         
Sub-Investigator: Alban Brougère, MD         
Sub-Investigator: Nathalie Valade, MD         
Sub-Investigator: Jacques Ripart, MD PhD         
Polyclinique Grand Sud Recruiting
Nîmes, Gard, France, 30029
Sub-Investigator: Patrick Basset, MD         
Sub-Investigator: Gilles Benistand, MD         
Sub-Investigator: Eric Veyrat, MD         
Sub-Investigator: Bérengère Etesse, MD         
Sub-Investigator: Patrick Mayo, MD         
Sub-Investigator: Marc Grossetete, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Arnaud Chaumeron, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01259648     History of Changes
Other Study ID Numbers: LOCAL/2009/AC-02, 2009-018169-12
Study First Received: December 13, 2010
Last Updated: March 3, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
remifentanil
anesthesia induction
reactional tachycardia

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anesthetics
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on April 17, 2014