Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT05932160
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Intravenous Dextrose on PONV in Patients Undergoing Gynecological Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'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'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple (Participant, Care Provider, Outcomes Assessor)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-02', 'studyFirstSubmitDate': '2023-06-06', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'Measured at 0.5 hours postoperatively.', 'description': 'The severity and incidence of PONV at 0.5 hours postoperatively.'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'Measured at 2 hours postoperatively.', 'description': 'The severity and incidence of PONV at 2 hours postoperatively.'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'Measured at 24 hours postoperatively.', 'description': 'The severity and incidence of PONV at 24 hours postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Consumption of postoperative analgesic', 'timeFrame': 'Approximately 24 hours after surgery.', 'description': 'Record the type and dosage of postoperative analgesic within 24 hours after surgery.'}, {'measure': 'Postoperative pain response', 'timeFrame': 'Measured at 0.5 hours postoperatively.', 'description': 'The Visual Analog Score was used to assess pain response at 0.5 hours postoperatively.\n\nThe score ranges from 0 (pain free or no pain) to 10 (worst pain).'}, {'measure': 'Postoperative pain response', 'timeFrame': 'Measured at 2 hours postoperatively.', 'description': 'The Visual Analog Score was used to assess pain response at 2 hours postoperatively.\n\nThe score ranges from 0 (pain free or no pain) to 10 (worst pain).'}, {'measure': 'Postoperative pain response', 'timeFrame': 'Measured at 24 hours postoperatively.', 'description': 'The Visual Analog Score was used to assess pain response at 24 hours postoperatively.\n\nThe score ranges from 0 (pain free or no pain) to 10 (worst pain).'}, {'measure': 'Recovery time of PACU', 'timeFrame': 'Approximately 24 hours after surgery.', 'description': 'Record PACU recovery time in hours. The criteria for discharge from PACU was the achievement of a modified Aldrete score ≥ 9.'}, {'measure': 'Consumption of postoperative rescue antiemetic', 'timeFrame': 'Approximately 24 hours after surgery.', 'description': 'Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PONV'], 'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'This study is to explore the relationship between intravenous infusion of dextrose during emergence from anesthesia and the incidence of PONV in patients undergoing gynecology laparoscopy (GL).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA I or II;\n2. Performing gynecologic laparoscopic procedures under general anesthesia;\n\nExclusion Criteria:\n\n1. age \\<18 or \\>75\n2. severe hypertension,diabetes mellitus, significant hepatic or renal disease\n3. inability to follow protocol\n4. refusal to participant'}, 'identificationModule': {'nctId': 'NCT05932160', 'briefTitle': 'Effect of Intravenous Dextrose on PONV in Patients Undergoing Gynecological Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Weifang Medical University'}, 'officialTitle': 'Research Investigator', 'orgStudyIdInfo': {'id': '2023YX104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental group', 'description': 'Patients in the experimental group were infused intravenously with 5% dextrose (400 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator.', 'interventionNames': ['Other: 5% glucose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients in the control group were infused intravenously with ringer lactate solution (400 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator.', 'interventionNames': ['Other: lactated ringers']}], 'interventions': [{'name': '5% glucose', 'type': 'OTHER', 'otherNames': ['5% dextrose'], 'description': 'Patients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU.', 'armGroupLabels': ['Experimental group']}, {'name': 'lactated ringers', 'type': 'OTHER', 'description': 'Patients in the control group were infused intravenously with lactated ringers (500 ml/h) in the PACU.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '265100', 'city': 'Weifang', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiang Liu, B.S', 'role': 'CONTACT', 'email': 'Time1987fx@163.com', 'phone': '17667192336'}], 'facility': 'Jiang Liu', 'geoPoint': {'lat': 36.71, 'lon': 119.10194}}], 'centralContacts': [{'name': 'Jiang Liu, B.S', 'role': 'CONTACT', 'email': 'Time1987fx@163.com', 'phone': '17667192336'}], 'overallOfficials': [{'name': 'Jiang Liu, B.S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weifang Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weifang Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research investigator', 'investigatorFullName': 'Jiang Liu', 'investigatorAffiliation': 'Weifang Medical University'}}}}