Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients. (RAM-TF-IOCV)

Instituto de Oftalmología Fundación Conde de Valenciana

Status: Enrolling

Conditions: Hypertension; Ophthalmology; Cardiovascular Complication; Phenylephrine; Adverse Drug Effect; Ocular Discomfort

Treatments: Drug: Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.

Study type: Observational

Funder types: Other

Identifiers

NCT07178600

CI-042-2023 (Other Identifier)

CB-042-2023 (Other Identifier)

CEI-2023/09/02

Details and patient eligibility

About

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.

Full description

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.

Materials and Methods:

An ambispective study will be conducted to identify ADRs associated with TF administration, as well as to characterize pathologies that may predispose patients to ADRs (clinical determinants, CD), through the use of a questionnaire, with the purpose of establishing an association between them.

Data Analysis:

Results will be analyzed using the Chi-square test for qualitative variables and the calculation of odds ratios (OR) with 95% confidence intervals. Quantitative variables will be analyzed using the Student's t-test for normally distributed data, or the Wilcoxon signed-rank test for data not normally distributed. Normality will be assessed with the Kolmogorov-Smirnov test (p > 0.05). The association between CDs and ADRs will be evaluated through logistic regression analysis

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have authorized participation in the study by signing informed consent.
• Patients over 18 years of age.
• Any sex.
• 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

Exclusion criteria

• Allergy to any component of the formulation.

Trial design

1,000 participants in 1 patient group

Hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL.

Description:

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

Treatment:

Drug: Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.