Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-02 @ 12:31 PM
Study NCT ID:
NCT06197659
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2023-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Liberal and Restrictive Fluids on Nausea-vomiting
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'patients, care providers, and outcome assessors will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two group;\n\n1. Experimental Group: Group L; Liberal Fluid Group; Peroperative 20 mL/kg/h intravenous ringer lactate will be administered.\n2. Sham Comparator: Group R; Restrictive Fluid Group; Peroperative 5 mL/kg/h intravenous ringer lactate will be administered.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2023-12-26', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative nausea-vomiting', 'timeFrame': 'Postoperative 24 hours', 'description': 'Incidence of nausea and vomiting within 24 hours after surgery. The presence of at least one episode of nausea, retching and vomiting in the first 24 hours postoperatively will be considered a positive result.'}, {'measure': 'Quality of recovery', 'timeFrame': 'Postoperative 24 hours', 'description': 'Quality of recovery will be evaluated at the 24th hour using the QoR-15 scale. It is a scale consisting of 15 questions and scoring from 0 to 10 for each question. 0 represents the worst and 150 represents the best recovery quality.'}], 'secondaryOutcomes': [{'measure': 'Time to first antiemetic request', 'timeFrame': 'Postoperative 24 hours', 'description': 'Time to first antiemetic request within 24 hours after surgery'}, {'measure': 'Time to request first oral drink', 'timeFrame': 'Postoperative 24 hours', 'description': 'Time to request first oral drink within 24 hours after surgery'}, {'measure': 'First mobilization time', 'timeFrame': 'Postoperative 24 hours', 'description': 'First mobilization time after surgery'}, {'measure': 'Total amount of analgesic', 'timeFrame': 'Postoperative 24 hours', 'description': 'Total amount of rescue analgesic (tramadol) in the 24 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative Nausea and Vomiting', 'Laparoscopic Cholecystectomy'], 'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'Patients planned for laparoscopic cholecystectomy will be included in this study. The effects of liberal and restrictive fluid regimens given peroperatively to patients undergoing laparoscopic cholecystectomy will be compared on postoperative nausea and vomiting. The aim of this study is to investigate which regimen is more effective on postoperative nausea and vomiting in laparoscopic cholecystectomy.', 'detailedDescription': 'Postoperative nausea and vomiting (PONV) is a common and disturbing side effect of anesthesia and surgery, and while its incidence in all surgical procedures varies between 20-77% if antiemetic prophylaxis is not applied, this rate is even higher in people prone to vomiting, such as cyclic vomiting syndrome . Its incidence varies between 53 - 72%, especially in patients undergoing laparoscopic cholecystectomy surgery, if antiemetic prophylaxis is not administered.\n\nSince most existing antiemetics are expensive and cannot completely eliminate PONV, pharmacological PONV prophylaxis may not be cost-effective. For this reason, the incidence of PONV can be reduced by increasing the amount of inexpensive fluid used during surgery instead of prophylactic drug treatment. There are several studies investigating the effect of different perioperative fluid administration schemes on PONV in the adult population, especially in patients undergoing laparoscopic cholecystectomy or gynecological surgery, with variable results.\n\nBased on this point, the inestigetors wanted to examine the effect of perioperative liberal and restrictive fluid treatments on PONV in patients who underwent laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients planned for laparoscopic cholecystectomy\n* Patients aged 18-70\n\nExclusion Criteria:\n\n* Congestive heart failure.\n* Diabetes.\n* Epilepsy.\n* Heart valve disease.\n* They are pregnant.\n* Chronic liver disease.\n* Chronic kidney disease. Chronic gastrointestinal tract disease. Those who used antiemetic drugs within 24 hours before surgery. Those who developed intraoperative hypertension. Those who develop excessive blood loss. Patients whose surgery procedure takes more than 2 hours.'}, 'identificationModule': {'nctId': 'NCT06197659', 'briefTitle': 'Effect of Liberal and Restrictive Fluids on Nausea-vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Karaman Training and Research Hospital'}, 'officialTitle': 'The Effect of Peroperative Restrictive and Liberal Fluid Regimens on Postoperative Nausea-vomiting and Quality of Recovery in Laparoscopic Cholecystectomy: a Prospective Randomized Study.', 'orgStudyIdInfo': {'id': '10-2023/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liberal Fluid Group', 'description': 'Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively.', 'interventionNames': ['Other: Liberal Fluid Grubu']}, {'type': 'SHAM_COMPARATOR', 'label': 'Restrictive Fluid Group', 'description': 'Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively.', 'interventionNames': ['Other: Restrictive Fluid Group']}], 'interventions': [{'name': 'Liberal Fluid Grubu', 'type': 'OTHER', 'otherNames': ['Liberal group'], 'description': 'Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively.', 'armGroupLabels': ['Liberal Fluid Group']}, {'name': 'Restrictive Fluid Group', 'type': 'OTHER', 'otherNames': ['Restrictive group'], 'description': 'Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively.', 'armGroupLabels': ['Restrictive Fluid Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200', 'city': 'Karaman', 'country': 'Turkey (Türkiye)', 'facility': 'Karaman Taining and Research Hospital', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'overallOfficials': [{'name': 'Muhammet Korkusuz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karamanoglu Mehmetbey University, School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karaman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD', 'investigatorFullName': 'muhammet korkusuz', 'investigatorAffiliation': 'Karaman Training and Research Hospital'}}}}