NCT07178600Recruiting
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.
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 11 Sept 2025
- Start date
- 2 Sept 2023
- Primary completion date
- Sept 2026
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Diseases
- High blood pressure
- NCT number
- NCT07178600
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 2 Sept 2023 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergy to any component of the formulation.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.