What is this study trying to find out about adverse drug reactions to tropicamide/phenylephrine?

This study is evaluating how certain clinical factors in hospitalized patients may be linked to adverse drug reactions after receiving tropicamide/phenylephrine 8 mg/50 mg/mL. It aims to improve understanding of who may be at risk and help enhance the safety of this eye medication. The Instituto de Oftalmología Fundación Conde de Valenciana is leading this research.

Who may be eligible for this adverse drug reaction clinical trial?

Adults aged 18 years or older who are scheduled for surgery and will receive tropicamide/phenylephrine 8 mg/50 mg/mL may be eligible. Both men and women can participate. People with allergies to the medication components cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this adverse drug reaction clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Age: 18Years +

All Genders

ID07178600

Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of TropicamidePhenylephrine in Hospitalized Patients

Led by Instituto de Oftalmología Fundación Conde de Valenciana · Updated on 2025-09-17

1000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the relationship between clinical factors and the occurrence of adverse drug reactions in hospitalized patients who receive tropicamidephenylephrine 8 mg50 mgmL. This study aims to identify which clinical determinants may increase the risk of these reactions and provide safety information for this commonly used ophthalmic drug combination. It also seeks to establish safety measures for patients undergoing eye examinations or surgery where these drugs are used. The study involves hospitalized patients scheduled for surgery who will receive two drops of tropicamidephenylephrine 8 mg50 mgmL. Vital signs will be measured before administration and then at several time points afterward, including 5, 15, 30 minutes, and 1, 2, and 3 hours post-administration. Data will be collected using questionnaires and analyzed to find associations between clinical factors and adverse reactions. Participants will be monitored closely through vital sign checks and questionnaires during the study period. Researchers will evaluate adverse drug reactions and clinical determinants to understand their connection. The main outcome is to assess vital signs at set intervals following drug administration and identify any adverse reactions. The study is observational and aims to enhance the safety profile of this medication in hospitalized patients.

CONDITIONS

Brief Title

Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.

Who Can Participate

Age: 18Years +

All Genders

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, scheduled for a surgical procedure.
Patients for whom two drops of tropicamide/phenylephrine 8 mg/50 mg/mL are indicated.
Patients that present any type of disease.

You will not qualify if you...

Allergy to any component of the formulation.

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