drugset / Trial / NCT02048293
Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules
Phase 4
Completed
90 enrolled
Fundación Universitaria de Ciencias de la Salud
Hospital de San Jose · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2012-10
- Primary completion
- 2013-10
- Completion
- 2013-12
Publications
- Background Kwak HJ, Min SK, Kim DH, Kang M, Kim JY. Effect-site concentration of remifentanil for nasotracheal versus orotracheal intubation during target-controlled infusion of propofol. J Int Med Res. 2011;39(5):1816-23. doi: 10.1177/147323001103900524.
- Background Lysakowski C, Dumont L, Pellegrini M, Clergue F, Tassonyi E. Effects of fentanyl, alfentanil, remifentanil and sufentanil on loss of consciousness and bispectral index during propofol induction of anaesthesia. Br J Anaesth. 2001 Apr;86(4):523-7. doi: 10.1093/bja/86.4.523.
- Background Coskun D, Celebi H, Karaca G, Karabiyik L. Remifentanil versus fentanyl compared in a target-controlled infusion of propofol anesthesia: quality of anesthesia and recovery profile. J Anesth. 2010 Jun;24(3):373-9. doi: 10.1007/s00540-010-0898-1. Epub 2010 Mar 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Remifentanil | Small molecule | 6 ng/ml | — |
| Comparator | Remifentanil | Small molecule | 8 ng/ml | — |
| Comparator | Remifentanil | Small molecule | 10 ng/ml | — |
Indications
No indication recorded.