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Completed

NCT Number: NCT02048293

Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Bogota, Cundinamarca, 11001000, Colombia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanyl, Ultiva®

Drug

Anesthetic induction for orotracheal intubation. Group O

Remifentanil Laboratorios Chalver de Colombia S.A.

Drug

Anesthetic induction for orotracheal intubation. Group A

Fada Remifentanilo

Drug

Anesthetic induction for orotracheal intubation. Group B

Primary outcomes

  1. Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation

    Time frame: Average of 5 minutes

    Heart rate measured with EKG. Mean arterial pressure measured with automatic blood pressure cuff.

Secondary outcomes

  1. Cooper intubation condition score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fundación Universitaria de Ciencias de la Salud

Other

Collaborators

  • Hospital de San Jose

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 29, 2014
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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