Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-10 @ 2:24 AM
Study NCT ID:
NCT02809950
Status:
UNKNOWN
Last Update Posted:
2018-06-20
First Post:
2016-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of nausea and vomiting', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'severity of nausea', 'timeFrame': '48 hours', 'description': '11-point numerical rating scale (0: no nausea \\~10: worst imaginable nausea)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postoperative nausea and vomiting, oral carbohydrate beverage'], 'conditions': ['Spinal Disease']}, 'descriptionModule': {'briefSummary': 'Many patients receiving opioid based analgesia after spinal surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with antiemetic agents. Dehydration caused by fasting prior to surgery is associated with the development of PONV. The aim of this study is to investigate the effect of oral carbohydrates loading prior to surgery in patients at high risk of PONV undergoing spinal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅱ\n* patient scheduled for elective spine surgery\n* no smoking history\n\nExclusion Criteria:\n\n* hepatorenal disease\n* BMI \\> 35 kg/m2\n* gastrointestinal disease\n* vomiting within 24h\n* administration of antiemetics or opioids within 24 h prior to surgery\n* pregnant\n* problem with communication'}, 'identificationModule': {'nctId': 'NCT02809950', 'briefTitle': 'Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2015-0984'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oral carbohydrate beverage group', 'interventionNames': ['Other: oral carbohydrate beverage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'oral carbohydrate beverage', 'type': 'OTHER', 'description': 'oral carbohydrate beverage (12.8% carbohydrates, 50 kcal/100ml, 290 mOsm/kg, NO-NPO®, Daesang WelLife Co., Ltd., Korea) 400ml in the evening of the day before surgery and at 6 am on the day of surgery, respectively', 'armGroupLabels': ['oral carbohydrate beverage group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'NPO from midnight of the day before surgery', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Sun Cho, MD', 'role': 'CONTACT', 'email': 'chjs0214@yuhs.ac', 'phone': '82-2-2227-0396'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jin Sun Cho, MD', 'role': 'CONTACT', 'email': 'chjs0214@yuhs.ac', 'phone': '82-2-2227-0396'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}