[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adverse-drug-effect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adverse-drug-effect":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"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":20,"type":21},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.",[25,26,27,28,29,30],"Adverse Drug Effect","Phenylephrine","Hypertension","Cardiovascular Complication","Ophthalmology","Ocular Discomfort",[25,32,33,34,35,27,29,36],"Tropicamide\u002Fphenylefrine","Tropicamide","Phenylefrine","Cardiovascular complications","Ocular discomfort","RECRUITING","2025-09-11",{"date":40,"type":41},"2025-09-17","ACTUAL",{"date":43,"type":41},"2023-09-02",{"date":45,"type":21},"2026-09",{"name":47,"class":48},"Instituto de Oftalmología Fundación Conde de Valenciana","OTHER"]