Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-13 @ 12:30 AM
Study NCT ID:
NCT03114735
Status:
UNKNOWN
Last Update Posted:
2017-04-14
First Post:
2017-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Preoperative Anxiety and Pain Sensitivity in Cases of Endoscopic Ultrasonography Received Sedoanalgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2017-03-25', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'consumption of propofol(mg)', 'timeFrame': '1-3 hours', 'description': 'initial dose infusion of 1 mg.kg-1 , maintenance dose 2 mg/kg/h, additional dose 0,1mg/kg in case of insufficient sedation'}, {'measure': 'the heart rate(n/min)', 'timeFrame': '1-3 hours', 'description': 'During procedure'}, {'measure': 'arterial pressure(mmHg)', 'timeFrame': '1-3 hours', 'description': 'During procedure'}, {'measure': 'peripheral oxygen saturation(%)', 'timeFrame': '1-3 hours', 'description': 'during procedure'}, {'measure': 'postoperative nausea and vomiting (Numeric Rank Score)', 'timeFrame': '1-3 hours', 'description': 'After procedure'}, {'measure': 'Post-procedure pain(Visual Analog Score)', 'timeFrame': '1-3 hours', 'description': 'After procedure'}]}, 'conditionsModule': {'conditions': ['Sedoanalgesia']}, 'referencesModule': {'references': [{'pmid': '34292516', 'type': 'DERIVED', 'citation': 'Yilmaz Inal F, Yilmaz Camgoz Y, Daskaya H, Kocoglu H. The Effect of Preoperative Anxiety and Pain Sensitivity on Preoperative Hemodynamics, Propofol Consumption, and Postoperative Recovery and Pain in Endoscopic Ultrasonography. Pain Ther. 2021 Dec;10(2):1283-1293. doi: 10.1007/s40122-021-00292-7. Epub 2021 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to detect whether preoperative anxiety and pain sensitivity had effects on the consumption of anesthetics, time to achieve desired level of sedation, patient and endoscopist satisfaction, and postoperative recovery time and pain in deep sedation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients scheduled for elective endoscopic ultrasonography with deep sedation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-2 category\n* between the ages of 20 and 65\n* patients who has an education level and mental state to complete the scale and questionnaire provided for assessment\n\nExclusion Criteria:\n\n* patients who has a psychiatric and neurological disease and use psychiatric drugs and chronic alcohol intake'}, 'identificationModule': {'nctId': 'NCT03114735', 'briefTitle': 'Effects of Preoperative Anxiety and Pain Sensitivity in Cases of Endoscopic Ultrasonography Received Sedoanalgesia', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medeniyet University'}, 'officialTitle': 'The Effects of Preoperative Anxiety and Pain Sensitivity on the Intraoperative Hemodynamics, Consumption of Propofol and Postoperative Recovery in Cases of Endoscopic Ultrasonography (EUS) Received Sedoanalgesia', 'orgStudyIdInfo': {'id': '71306642-050.01.04-21/28'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medeniyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ferda Yilmaz Inal', 'investigatorAffiliation': 'Istanbul Medeniyet University'}}}}