[{"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":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":73,"overallStatus":23,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"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","clinical-determinants-and-adverse-reactions-to-tropicamidephenylephrine-in-hospitalized-patients-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":62,"type":63},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.",[67,68,69,70,71,72],"Adverse Drug Effect","Phenylephrine","Hypertension","Cardiovascular Complication","Ophthalmology","Ocular Discomfort",[67,74,75,76,77,69,71,78],"Tropicamide\u002Fphenylefrine","Tropicamide","Phenylefrine","Cardiovascular complications","Ocular discomfort","2025-09-11",{"date":81,"type":82},"2025-09-17","ACTUAL",{"date":84,"type":82},"2023-09-02",{"date":86,"type":63},"2026-09",{"name":5,"class":6},1]