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

Study acronym: RAM-TF-IOCV
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated September 17, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07178600
Lead Sponsor Instituto de Oftalmología Fundación Conde de Valenciana
Conditions
(from sponsor)		 Adverse Drug Effect, Phenylephrine, Hypertension, Cardiovascular Complication, Ophthalmology, Ocular Discomfort
Related terms Drug-Related Side Effects and Adverse Reactions, Hypertension
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov