Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules Available in Colombia for Tracheal Intubation of Adult Patients, 2012-2013
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring orotracheal intubation
- •18-50 years old
- •Body mass index <31 kg/m2
- •Written informed consent
排除标准
- •Pregnancy
- •Risk of difficult airway
- •History of opioid use
研究组 & 干预措施
Group O
Remifentanyl innovative molecule = Ultiva®
干预措施: Remifentanyl, Ultiva® (Drug)
Group O
Remifentanyl innovative molecule = Ultiva®
干预措施: Fada Remifentanilo (Drug)
Group A
Remifentanyl comparator A = Remifentanil Laboratorios Chalver de Colombia S.A.
干预措施: Remifentanil Laboratorios Chalver de Colombia S.A. (Drug)
Group A
Remifentanyl comparator A = Remifentanil Laboratorios Chalver de Colombia S.A.
干预措施: Fada Remifentanilo (Drug)
Group B
Remifentanyl comparator B = Fada Remifentanilo
干预措施: Remifentanyl, Ultiva® (Drug)
Group B
Remifentanyl comparator B = Fada Remifentanilo
干预措施: Remifentanil Laboratorios Chalver de Colombia S.A. (Drug)
结局指标
主要结局
Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation
时间窗: Average of 5 minutes
Heart rate measured with EKG. Mean arterial pressure measured with automatic blood pressure cuff.
次要结局
- Cooper intubation condition score(Measured during tracheal intubation, average of 30 seconds)
研究者
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.
Fundación Universitaria de Ciencias de la Salud