Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules

Study Overview
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Brief Summary
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Unbranded drug molecules are produced after the patent of a given drug has expired. Unbranded molecules of Remifentanil have been marketed in Colombia, and several reports by anesthesiologist indicate that there are differences in the physiologic response of patients to these molecules. The investigators hypothesized that unbranded molecules of remifentanil require higher doses to obtain desired physiological responses as compared to the branded molecule.

Detailed Description
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Introduction. Several remifentanil products are commercialized in Colombia while these have never been compared in a clinical setting. Objective. The aim of this study was to investigate the pharmacodynamic profile of the innovative molecule of remifentanil (group O = Ultiva®) and two unbranded molecules (group A = Remifentanil Laboratorios Chalver de Colombia S.A. and group B = Fada Remifentanilo) registered in Colombia. Methods. The investigators carried out a double-blind, randomized, controlled trial. The branded molecule of remifentanil (group O, n=29) was compared against the two unbranded molecules (group A, n=29; group B, n=32) during anesthetic induction and tracheal intubation in adult patients American Society of Anesthesiology Physical Status Classification = I without predictors for difficult airway. The target controlled infusion (TCI) doses evaluated were 6, 8 and 10 ng/ml with the Minto model. Induction was complemented with propofol 5 mg/ml (TCI) with the Schneider model and rocuronium 0.6 mg/kg. The primary outcome was defined as the difference in mean arterial pressure and heart rate pre-intubation (TCI equilibrium) and post-intubation (maximum measurement within 5 minutes).

Official Title
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Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules Available in Colombia for Tracheal Intubation of Adult Patients, 2012-2013

Conditions
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Pain

Intervention / Treatment
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* Drug: Remifentanyl, Ultiva®
* Drug: Remifentanil Laboratorios Chalver de Colombia S.A.
* Drug: Fada Remifentanilo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring orotracheal intubation 18-50 years old Body mass index <31 kg/m2 Written informed consent Exclusion Criteria: Pregnancy Risk of difficult airway History of opioid use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group O<br>Remifentanyl innovative molecule = Ultiva® | Drug: Remifentanyl, Ultiva®<br>* Anesthetic induction for orotracheal intubation. Group O<br>Drug: Fada Remifentanilo<br>* Anesthetic induction for orotracheal intubation. Group B<br>|
| Active Comparator: Group A<br>Remifentanyl comparator A = Remifentanil Laboratorios Chalver de Colombia S.A. | Drug: Remifentanil Laboratorios Chalver de Colombia S.A.<br>* Anesthetic induction for orotracheal intubation. Group A<br>Drug: Fada Remifentanilo<br>* Anesthetic induction for orotracheal intubation. Group B<br>|
| Active Comparator: Group B<br>Remifentanyl comparator B = Fada Remifentanilo | Drug: Remifentanyl, Ultiva®<br>* Anesthetic induction for orotracheal intubation. Group O<br>Drug: Remifentanil Laboratorios Chalver de Colombia S.A.<br>* Anesthetic induction for orotracheal intubation. Group A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation | Heart rate measured with EKG. Mean arterial pressure measured with automatic blood pressure cuff. | Average of 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cooper intubation condition score | Jaw relaxation: 0 poor, 1 minimum, 2 moderate, 3 good. Vocal cords: 0 closed, 1 closing, 2 moving, 3 open. Intubation response: 0 severe cough, 1 mild cough, 2 mild diaphragmatic movement, 3 no response. Cooper score: Jaw relaxation + Vocal cords + Intubation response | Measured during tracheal intubation, average of 30 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remifentanil, propofol, pharmacodynamic, total intravenous anesthesia, orotracheal intubation, heart rate, mean arterial pressure, Cooper intubation condition score