Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules
- Conditions
- Pain
- Interventions
- Drug: Remifentanyl, Ultiva®
- Registration Number
- NCT02048293
- Lead Sponsor
- Fundación Universitaria de Ciencias de la Salud
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Patients requiring orotracheal intubation
- 18-50 years old
- Body mass index <31 kg/m2
- Written informed consent
- Pregnancy
- Risk of difficult airway
- History of opioid use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group O Fada Remifentanilo Remifentanyl innovative molecule = Ultiva® Group O Remifentanyl, Ultiva® Remifentanyl innovative molecule = Ultiva® Group A Remifentanil Laboratorios Chalver de Colombia S.A. Remifentanyl comparator A = Remifentanil Laboratorios Chalver de Colombia S.A. Group B Remifentanyl, Ultiva® Remifentanyl comparator B = Fada Remifentanilo Group B Remifentanil Laboratorios Chalver de Colombia S.A. Remifentanyl comparator B = Fada Remifentanilo Group A Fada Remifentanilo Remifentanyl comparator A = Remifentanil Laboratorios Chalver de Colombia S.A.
- Primary Outcome Measures
Name Time Method Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation Average of 5 minutes Heart rate measured with EKG. Mean arterial pressure measured with automatic blood pressure cuff.
- Secondary Outcome Measures
Name Time Method Cooper intubation condition score Measured during tracheal intubation, average of 30 seconds 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
Trial Locations
- Locations (1)
Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose
🇨🇴Bogota, Cundinamarca, Colombia