Actively Recruiting
Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.
Led by Instituto de Oftalmología Fundación Conde de Valenciana · Updated on 2025-09-17
1000
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 present any type of disease
You will not qualify if you...
- Allergy to any component of the formulation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
Mexico City, Mexico Ciy, Mexico, 06800
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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