[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606672":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":20,"responsibleParty":48,"collaborators":10,"id":51,"slug":10,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":72,"overallStatus":23,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Instituto de Oftalmología Fundación Conde de Valenciana","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hospitalized patients who received tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL.",null,"Patients over 18 years of age who have been hospitalized to undergo a surgical procedure and who received tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL at the Instituto de Oftalmologia 'Conde de Valenciana' IAP",[13],"Drug: Ophthalmic administration of tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Ophthalmic administration of tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL.","Measurement of vital signs after ophthalmic administration of tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL",[9],[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro","RECRUITING","Mexico City","Mexico Ciy","06800","Mexico","MX",{"type":30,"coordinates":31},"Point",[32,33],-99.12766,19.42847,{"lat":33,"lon":32},[36,42,45],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Mitzi D Vera Sánchez, physician","CONTACT","(55) 54421700","3749","mitzi.vera@condeinvestigacion.org",{"name":43,"role":38,"phone":39,"phoneExt":40,"email":44},"Lorenzo Islas Vázquez, PhD. Biologic Sciences","lorenzo.islas@institutodeoftalmologia.org",{"name":46,"role":47,"phone":10,"phoneExt":10,"email":10},"Maria C. Jimenez Martinez, (55) 54421700","PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"María C. Jiménez Martínez","Head of the inmunology department, Research unity","100606672",false,"NCT07178600","Clinical Determinants and Adverse Reactions to Tropicamide\u002FPhenylephrine in Hospitalized Patients.","Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide\u002FPhenylephrine in Hospitalized Patients.","RAM-TF-IOCV","Inclusion Criteria:\n\n* Patients who have authorized participation in the study by signing informed consent.\n* Patients over 18 years of age.\n* Any sex.\n* Patients from the \"Instituto de Oftalmología Conde de Valenciana, IAP., sede Centro\" who have been scheduled for a surgical procedure.\n* Patients for whom the administration of two drops of tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL is indicated.\n* Patients that presents any type of disease\n\nExclusion Criteria:\n\n* Allergy to any component of the formulation.","ALL","18 Years",{"count":61,"type":62},1000,"ESTIMATED","OBSERVATIONAL","To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL.\n\nAn ambispective, interventional, longitudinal study will be conducted to actively identify adverse reactions to tropicamide\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL, 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\u002Fphenylephrine 8 mg\u002F50 mg\u002FmL, 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.",[66,67,68,69,70,71],"Adverse Drug Effect","Phenylephrine","Hypertension","Cardiovascular Complication","Ophthalmology","Ocular Discomfort",[66,73,74,75,76,68,70,77],"Tropicamide\u002Fphenylefrine","Tropicamide","Phenylefrine","Cardiovascular complications","Ocular discomfort","2025-09-11",{"date":80,"type":81},"2025-09-17","ACTUAL",{"date":83,"type":81},"2023-09-02",{"date":85,"type":62},"2026-09",{"name":5,"class":6},1]