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NCT01259648 Clinical Trial

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

Tachycardia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01259648
Other study ID # LOCAL/2009/AC-02
Secondary ID 2009-018169-12
Status Completed
Phase Phase 4
First received
Last updated
Start date March 9, 2011
Est. completion date May 20, 2014

Study information
Verified date March 2022
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date May 20, 2014
Est. primary completion date May 20, 2014
Accepts healthy volunteers No
Gender All
Age group 65 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• 0.5 µg/kg remifentanil
0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol
• 1.0 µg/kg remifentanil
1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol
• 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

Locations
Country Name City State
France Centre Hospitalier Universitaire de Nîmes Nîmes Gard
France Polyclinique Grand Sud Nîmes Gard

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac frequency (beats per minute) Patient cardiac frequency (beats per minute) at the time of induction 15 minutes
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