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.
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.
Allergy to any component of the formulation.
Patients over 18 years of age who have been hospitalized to undergo a surgical procedure at the "Instituto de Oftalmología Conde de Valenciana, IAP".
Cohort
Other
Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.
DrugMeasurement of vital signs after ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL
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)
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
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.
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.
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