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.
Instituto de Oftalmología Fundación Conde de Valenciana
1,000 participants
Sep 2, 2023
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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 Criteria1
- Allergy to any component of the formulation.
Interventions
Measurement of vital signs after ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL
Locations(1)
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NCT07178600