Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048293
• Other study ID #: 326-3847-22
• Status: Completed
• Phase: Phase 4
• First received: January 23, 2014
• Last updated: January 28, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Fundación Universitaria de Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Remifentanyl, Ultiva®
Anesthetic induction for orotracheal intubation. Group O
• Remifentanil Laboratorios Chalver de Colombia S.A.
Anesthetic induction for orotracheal intubation. Group A
• Fada Remifentanilo
Anesthetic induction for orotracheal intubation. Group B

Locations

Country	Name	City	State
Colombia	Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose	Bogota	Cundinamarca

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Universitaria de Ciencias de la Salud	Hospital de San Jose

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No