Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT03426020
Status:
UNKNOWN
Last Update Posted:
2018-02-08
First Post:
2017-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Effect of pharmacologic or nonpharmacologic premedication on emergency agitation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-01', 'studyFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergence agitation', 'timeFrame': 'Postoperative every 5 minutes for 15 minutes', 'description': 'Emergence agitation will be evaluated by PAED (pediatric anesthesia emergence dellirium).The PAED scale consists of five behaviors, each of which is rated on a five-level scale with a score of zero to four. The scores are added to achieve a total scale score (maximum value is 20). The score above 12 is significant for post operative emergence agitation.'}], 'secondaryOutcomes': [{'measure': 'preoperative anxiety', 'timeFrame': '20 minutea after premedications.', 'description': 'Preoperative anxiety will be evaluated by Modified Yale Preoperative Anxiety Scale ( m-YPAS )scores. Range between 23 to 100. m-YPAS score above 30 is significant to patients anxiety.'}, {'measure': 'Post operative pain', 'timeFrame': 'Postoperative every 5 minutes for 15 minutes', 'description': 'Postoperative pain will be evaluated by behavioral pain scale FLACC(behavioral pain assesment scale). Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0 = Relaxed and comfortable.\n\n1 - 3 = mild discomfort 4 - 6 = moderate pain 7 - 10 = Severe discomfort or pain or both'}, {'measure': 'Mean arteriel pressure', 'timeFrame': 'Postoperative every 5 minutes for15 minutes', 'description': 'Mean arteriel pressure, will be measured. Mean blood pressurre range between 66 to 73 mm Hg is considered normal value. 20% increase in baseline value is considered significant.'}, {'measure': 'Heart rate', 'timeFrame': 'Postoperative every 5 minutes for15 minutes.', 'description': 'Heart rate range between 80 to 120 beats/minute is considered normal value. %20 percent increase in baseline value is considered significant.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premedication', 'Pediatric patients', 'Emergence agitation'], 'conditions': ['Emergence Agitation']}, 'descriptionModule': {'briefSummary': 'Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate, SpO2, and pain at PACU 15 minutes after adenotonsillectomy .', 'detailedDescription': 'Compare the effects of\n\n0.5 mg/kg oral midazolam,\n\nwatching film "Suko is being operated \'animation film (http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) and\n\nplaying a game named "fishing games" on postoperative emergency delirium by PAED (post anestesic emergency delirium) scale at PACU at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.\n\nInvestigators also evaluated "Basic and 20 minutes after pharmacologic and nonpharmacolgic premedications on participitans anxiety by Modified Yale Preoperative Anxiety Scale m-YPAS scores"\n\nPain evaluated by FLACC (behoviaral pain assesment scale),at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.\n\nBlood pressure(mmHg), heart rate(beat/min) and SpO2(%) measured and recorded at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* Pediatric patients\n* Elective surgery\n* Adenotonsillectomi\n\nExclusion Criteria:\n\n* Cronicdesease\n* Mental retarde\n* Hearing and visual impaired\n* Prematurite'}, 'identificationModule': {'nctId': 'NCT03426020', 'acronym': 'EDIRA', 'briefTitle': 'The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Diskapi Yildirim Beyazit Education and Research Hospital'}, 'officialTitle': 'The Effect of Three Different Interventions on the Recovery Agitation and Delirium in the Pacu Pediatric Patients', 'orgStudyIdInfo': {'id': '27/11/2017 43/20'}, 'secondaryIdInfos': [{'id': 'Ministry of Health', 'type': 'OTHER', 'domain': 'Diskapi Yildirim Beyazit Education and Research Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral midazolam (Demizolam®)', 'description': 'To prevent emergence agitation patient premedicated by 0.5 mg oral midazolam At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale).', 'interventionNames': ['Other: Oral midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor', 'description': 'To prevent emergence agitation patient premedicated by watching a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale).', 'interventionNames': ['Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Play game (PC fishing game)', 'description': 'To prevent emergence agitation patient premedicated by playing a simple PC game (fishing game) At the end of sugery patients postoperatif emergence agitation evaluated PAED(pediatric anesthesia emergence delirium scale).', 'interventionNames': ['Other: Play game (PC fishing game)']}], 'interventions': [{'name': 'Oral midazolam', 'type': 'OTHER', 'otherNames': ['Demizolam'], 'description': '0.5 mg/kg oral midazolam administered 20 minutes before induction', 'armGroupLabels': ['Oral midazolam (Demizolam®)']}, {'name': 'Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor', 'type': 'OTHER', 'description': 'patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction.', 'armGroupLabels': ['Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor']}, {'name': 'Play game (PC fishing game)', 'type': 'OTHER', 'description': 'Patients will be played a simple PC game (a fishing game) 20 minutes before induction', 'armGroupLabels': ['Play game (PC fishing game)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06610', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Reyhan Polat', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Reyhan Polat', 'role': 'CONTACT', 'email': 'reyhanp9@gmail.com', 'phone': '5326734310'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Yildirim Beyazit Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Profesor', 'investigatorFullName': 'Reyhan Polat', 'investigatorAffiliation': 'Diskapi Yildirim Beyazit Education and Research Hospital'}}}}