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

NCT07178600 | Recruiting FDA Drug

• 3 other identifiers: CEI-2023/09/02CB-042-2023CI-042-2023
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Drug Effect; Phenylephrine; Hypertension; Cardiovascular Complication; Ophthalmology; Ocular Discomfort

Keywords

Adverse Drug Effect; Tropicamide/phenylefrine; Tropicamide; Phenylefrine; Cardiovascular complications; Hypertension; Ophthalmology; Ocular discomfort

Outcome Measures

Primary Outcomes (3)

• 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)

  Measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 3 hours afterward.

• To identify and characterize the clinical determinants of hospitalized patients receiving tropicamide/phenylephrine 8 mg/50 mg/mL at the Instituto de Oftalmología Conde de Valenciana

  Identification of clinical determinants based on medical records review and patient interview.

  At enrollement

• To actively identify adverse reactions to tropicamide/phenylephrine 8 mg/50 mg/mL.

  To identify adverse drug reactions (ADRs) to tropicamide/phenylephrine 8 mg/50 mg/mL through a pharmacovigilance questionnaire administered to the patient and by measuring vital signs after administration.

  At enrollment Measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 3 hours afterward.

Study Arms (1)

Hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL.

Patients over 18 years of age who have been hospitalized to undergo a surgical procedure and who received tropicamide/phenylephrine 8 mg/50 mg/mL at the Instituto de Oftalmologia 'Conde de Valenciana' IAP

Drug: Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.

Interventions

Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL. DRUG

Measurement of vital signs after ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL

Hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age who have been hospitalized to undergo a surgical procedure at the "Instituto de Oftalmología Conde de Valenciana, IAP".

You may qualify if:

• 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

You may not qualify if:

• Allergy to any component of the formulation.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro

Mexico City, Mexico Ciy, 06800, Mexico

RECRUITING

Related Publications (1)

• Tsui E, Sehi M, Cheng RW, Wan J, Wong T, Dorner S, Fisher JA, Hudson C. The impact of topical mydriatic ophthalmic solutions on retinal vascular reactivity and blood flow. Exp Eye Res. 2013 Jul;112:134-8. doi: 10.1016/j.exer.2013.05.005. Epub 2013 May 21.

  PMID: 23701974 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Hypertension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the inmunology department, Research unity

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 17, 2025
• Study Start: September 2, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)