Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules

NCT ID: NCT02048293

Last Updated: 2014-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

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).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group O

Remifentanyl innovative molecule = Ultiva®

Group Type: ACTIVE_COMPARATOR

Remifentanyl, Ultiva®

Intervention Type: DRUG

Anesthetic induction for orotracheal intubation. Group O

Fada Remifentanilo

Intervention Type: DRUG

Anesthetic induction for orotracheal intubation. Group B

Group A

Remifentanyl comparator A = Remifentanil Laboratorios Chalver de Colombia S.A.

Group Type: ACTIVE_COMPARATOR

Remifentanil Laboratorios Chalver de Colombia S.A.

Intervention Type: DRUG

Anesthetic induction for orotracheal intubation. Group A

Fada Remifentanilo

Intervention Type: DRUG

Anesthetic induction for orotracheal intubation. Group B

Group B

Remifentanyl comparator B = Fada Remifentanilo

Group Type: ACTIVE_COMPARATOR

Remifentanyl, Ultiva®

Intervention Type: DRUG

Anesthetic induction for orotracheal intubation. Group O

Remifentanil Laboratorios Chalver de Colombia S.A.

Intervention Type: DRUG

Anesthetic induction for orotracheal intubation. Group A

Interventions

Remifentanyl, Ultiva®

Anesthetic induction for orotracheal intubation. Group O

Intervention Type: DRUG

Remifentanil Laboratorios Chalver de Colombia S.A.

Anesthetic induction for orotracheal intubation. Group A

Intervention Type: DRUG

Fada Remifentanilo

Anesthetic induction for orotracheal intubation. Group B

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de San Jose

OTHER

Sponsor Role: collaborator

Fundación Universitaria de Ciencias de la Salud

OTHER

Sponsor Role: lead

Responsible Party

Luis Eduardo Reyes Ortiz, MD

Physician, Anesthesiologist, Intensive Care Specialist, Professor Fundación Universitaria de Ciencias de la Salud, Hospital de San José, Bogotá D.C.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

luis e reyes, professor

Role: PRINCIPAL_INVESTIGATOR

fundacion universitaria de ciencias de la salud

Locations

Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose

Bogota, Cundinamarca, Colombia

Countries

Colombia

References

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.

Reference Type: BACKGROUND

PMID: 22117982 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11573626 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20229001 (View on PubMed)

Other Identifiers

326-3847-22

Identifier Type: -

Identifier Source: org_study_id