Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide/Phenylephrine in Hospitalized Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL.
研究概览
简要总结
To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL.
An ambispective, interventional, longitudinal study will be conducted to actively identify adverse reactions to tropicamide/phenylephrine 8 mg/50 mg/mL, as well as the clinical determinants that may predispose patients to the occurrence of an adverse drug reaction (ADR). Data will be collected through the administration of a questionnaire and measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and subsequently at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours after administration, with the aim of establishing an association between these variables.
详细描述
In the diagnostic approach of patients with ophthalmologic diseases, as well as for surgical purposes, the administration of mydriatic and cycloplegic drugs is indispensable. Among these, the combination of tropicamide and phenylephrine (TF) is commonly used. Studies evaluating the topical ocular administration of these medications have demonstrated an adequate risk-benefit balance; however, certain local and systemic safety aspects remain insufficiently evaluated.
Justification: This study will help identify the at-risk population (clinical determinants) prior to the administration of drugs such as TF, provide additional information regarding the safety profile of this drug at the 8 mg/50 mg/mL concentration, and propose measures to reduce the occurrence of adverse drug reactions (ADRs) in at-risk populations. It also aims to develop safety barriers that allow for safer administration of the medication. Moreover, this research provides a first approximation and establishes the basis for future studies that may compare different TF concentrations.
Hypothesis: There will be a positive association between clinical determinants and the occurrence of adverse drug reactions.
Research Question: Is there an association between the clinical determinants of hospitalized patients and the occurrence of adverse drug reactions following the administration of tropicamide/phenylephrine?
Objective: To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have authorized participation in the study by signing informed consent.
- •Patients over 18 years of age.
- •Patients from the "Instituto de Oftalmología Conde de Valenciana, IAP., sede Centro" who have been scheduled for a surgical procedure.
- •Patients for whom the administration of two drops of tropicamide/phenylephrine 8 mg/50 mg/mL is indicated.
- •Patients that presents any type of disease
排除标准
- •Allergy to any component of the formulation.
研究组 & 干预措施
Hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL.
Patients over 18 years of age who have been hospitalized to undergo a surgical procedure and who received tropicamide/phenylephrine 8 mg/50 mg/mL at the Instituto de Oftalmologia 'Conde de Valenciana' IAP
干预措施: Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL. (Drug)
结局指标
主要结局
To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL.
时间窗: Measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 3 hours afterward.
An ambispective, interventional, longitudinal study will be conducted to actively identify adverse reactions to tropicamide/phenylephrine 8 mg/50 mg/mL, as well as the clinical determinants that may predispose patients to the occurrence of an adverse drug reaction (ADR)
To identify and characterize the clinical determinants of hospitalized patients receiving tropicamide/phenylephrine 8 mg/50 mg/mL at the Instituto de Oftalmología Conde de Valenciana
时间窗: At enrollement
Identification of clinical determinants based on medical records review and patient interview.
To actively identify adverse reactions to tropicamide/phenylephrine 8 mg/50 mg/mL.
时间窗: At enrollment Measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 3 hours afterward.
To identify adverse drug reactions (ADRs) to tropicamide/phenylephrine 8 mg/50 mg/mL through a pharmacovigilance questionnaire administered to the patient and by measuring vital signs after administration.
次要结局
未报告次要终点
研究者
María C. Jiménez Martínez
Head of the inmunology department, Research unity
Instituto de Oftalmología Fundación Conde de Valenciana