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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstituto de Oftalmología Fundación Conde de Valenciana

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Allergy to any component of the formulation.

Trial design

Treatments tested in this trial

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

Treatment groups

1,000 Participants
are divided into 1 treatment group