Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects
This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01259648
First received: December 13, 2010
Last updated: March 25, 2013
Last verified: March 2013
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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: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (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 25, 2013 |
| 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 May 21, 2013