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RECRUITINGOBSERVATIONAL

Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.

Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide/Phenylephrine in Hospitalized Patients.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients who have authorized participation in the study by signing willing to sign a consent form. - 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 Who Should NOT Join This Trial: - Allergy to any component of the formulation. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

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

Measurement of vital signs after ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL

Locations (1)

Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
Mexico City, Mexico Ciy, Mexico