NCT07178600 Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.
| NCT ID | NCT07178600 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Oftalmología Fundación Conde de Valenciana |
| Condition | Adverse Drug Effect |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-09-02 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-09-02 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Frequently Asked Questions
Who can join the NCT07178600 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adverse Drug Effect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07178600 currently recruiting?
Yes, NCT07178600 is actively recruiting participants. Visit ClinicalTrials.gov or contact Instituto de Oftalmología Fundación Conde de Valenciana to inquire about joining.
Where is the NCT07178600 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT07178600 clinical trial?
NCT07178600 is sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. The trial plans to enroll 1,000 participants.