Pain
Conditions
Keywords
remifentanil, propofol, pharmacodynamic, total intravenous anesthesia, orotracheal intubation, heart rate, mean arterial pressure, Cooper intubation condition score
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).
Interventions
DRUGRemifentanyl, Ultiva®
Anesthetic induction for orotracheal intubation. Group O
DRUGRemifentanil Laboratorios Chalver de Colombia S.A.
Anesthetic induction for orotracheal intubation. Group A
DRUGFada Remifentanilo
Anesthetic induction for orotracheal intubation. Group B
Sponsors
Hospital de San Jose
Fundación Universitaria de Ciencias de la Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Colombia
Outcome results
None listed