Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT04531020
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2020-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence of Emergence Delirium in the PACU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1421}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2020-08-27', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of emergence delirium', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'The incidence of emergence delirium, defined as PAED score above 10 points and/or WATCHA score over 2 and or RASS over 1 minimally in one of the measurements. All measurements will be measured in 0., 5., 10., 15., and 20. minute after PACU admission. The first measurement (T0) will be intiated after first obtaining RASS over -2.'}], 'secondaryOutcomes': [{'measure': 'The duration of ED', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'The cumulative duration of ED will be measured'}, {'measure': 'The average PAED score', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'The average PAED score at PACU will be measured'}, {'measure': 'The need for pharmacology intervention incidence', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'The need for pharmacology intervention - defined by the number of therapeutic interventions'}, {'measure': 'incidence of postoperative nausea and vomiting (PONV)', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'incidence of postoperative nausea and vomiting (PONV) defined by the cumulative dose of administered antiemetics'}, {'measure': 'type of anaesthesia induction (inhalation vs. intravenous)', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'type of anaesthesia induction (inhalation vs. intravenous) will be evaluated'}, {'measure': 'type of anaesthesia (TIVA, combined, inhalational)', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'type of anaesthesia (TIVA, combined, inhalational) will be evaluated'}, {'measure': 'length of the surgery', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'length of the surgery will be evaluated'}, {'measure': 'type of the surgery', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'type of the surgery will be evaluated'}, {'measure': 'cumulative dose of administered sedatives', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'the cumulative dose of administered sedatives'}, {'measure': 'The average WATCHA score', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'The average WATCHA score at PACU will be measured'}, {'measure': 'The average RASS score', 'timeFrame': 'up to 60 minutes after PACU admission', 'description': 'The average RASS score at PACU will be measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergence delirium', 'Anaesthesia', 'Paediatric patient'], 'conditions': ['Emergence Delirium']}, 'descriptionModule': {'briefSummary': 'Emergence delirium (ED) is serious complication in the postoperative period in paediatric anaesthesia, reported incidence is 20-60%. It is characterized by psychomotor and perception disorder with excitation of paediatric patients. Emergence delirium has impact on morbidity and even on mortality of paediatric patients in the postoperative period.\n\nThe potential risk factors for ED development include sevoflurane, which is the dominant anaesthetic agent used in the paediatric patients, and which is actually the only inhalation agent used for inhalation anaesthesia induction. The incidence of ED is higher in postoperative period, for example in the Post-anaesthesia Care Unit - PACU. Patients with ED are at higher risk of psychomotor anxiety, agitation, unintentional extraction of intravenous cannula, and nausea and vomiting. For the therapy of ED propofol, midazolam and eventually ketamine in a reduced dosage are used.', 'detailedDescription': 'After the approval of the study by the Ethics Committee of the University hospital Brno and registration of the protocol at clinicaltrials.gov, the incidence of emergence delirium (ED) using PAED, WATCHA and Richmond agitation and sedation scale (RASS) score in patients hospitalized in the post-anaesthesia care unit (PACU) after general anaesthesia, in the Departement of paediatric anaesthesia and intensive care unit, University Hospital Brno in the term from 1.9.2020 until 30.6.2021 will be measured.\n\nPaediatric Emergence Delirium (PAED) score, WATCHA score and Richmond agitation and sedation scale (RASS) will be measured in 0., 5., 10., 15., and 20. minute after PACU admission and after obtaining RASS ≥ - 2 . Emergence delirium is defined as PAED score above 10 points. In the case of ED development, the duration of ED will be measured as well as the number of therapeutic interventions and the cumulative dose of administered sedatives. The average PAED, WATCHA, RASS scale will be reported, the incidence of postoperative nausea and vomiting (PONV) and the cumulative dose of administered antiemetics, the type of anaesthesia induction (inhalation vs. intravenous), type of anaesthesia (TIVA, combined, inhalational), length of the surgery, type of the surgery will be reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients after general anaesthesia hospitalized in the PACU', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients after general anaesthesia hospitalized in the PACU in the term rom 1.9.2020 until 30.6.2021.\n\nExclusion Criteria:\n\n* Patients in the age from 0 to 1 month.'}, 'identificationModule': {'nctId': 'NCT04531020', 'acronym': 'PACUDEL', 'briefTitle': 'Incidence of Emergence Delirium in the PACU', 'organization': {'class': 'OTHER', 'fullName': 'Brno University Hospital'}, 'officialTitle': 'Incidence of Emergence Delirium in the PACU: Prospective Observational Trial', 'orgStudyIdInfo': {'id': 'KDAR FN Brno 2020/10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients at PACU', 'description': 'Patients undergoing elective surgical or diagnostic intervention admitted to PACU after postanaesthesia recovery', 'interventionNames': ['Diagnostic Test: PAED measurement']}], 'interventions': [{'name': 'PAED measurement', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['PAED score measurement at PACU'], 'description': 'The incidence of emergence delirium, defined as PAED score above 10 points minimally in one of the PAED score measurements. PAED score will be measured in 0., 5., 10., 15., and 20. minute after PACU admission.', 'armGroupLabels': ['Patients at PACU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'state': 'Česká Republika', 'country': 'Czechia', 'facility': 'University Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Petr Štourač, prof. MD., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of medicince Masaryk University and University Hospital Brno'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brno University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Petr Štourač, MD', 'investigatorAffiliation': 'Brno University Hospital'}}}}