Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.
Recruiting · NCT07178600 · Observational (researchers observe without assigning treatment) · Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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.
Where it is running
1 location listed.
- Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro - Mexico City, Mexico Ciy, Mexico