Clinical trial NCT02048293: Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules
Official title: Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules Available in Colombia for Tracheal Intubation of Adult Patients, 2012-2013
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: remifentanil
propofol
pharmacodynamic
total intravenous anesthesia
orotracheal intubation
heart rate
mean arterial pressure
Cooper intubation condition score
Lead sponsor: Fundación Universitaria de Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Hospital de San Jose
First posted: 2014-01-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation
timeFrame: Average of 5 minutes
Secondary outcomes:
measure: Cooper intubation condition score
timeFrame: Measured during tracheal intubation, average of 30 seconds
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose
state: Cundinamarca
Study officials:
affiliation: fundacion universitaria de ciencias de la salud
name: luis e reyes, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.