Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 5:27 AM
Study NCT ID:
NCT03202459
Status:
UNKNOWN
Last Update Posted:
2017-06-28
First Post:
2017-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-27', 'studyFirstSubmitDate': '2017-06-23', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Nausea or vomiting M0', 'timeFrame': '1 hours', 'description': 'The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery'}, {'measure': 'Postoperative Nausea or vomiting M12', 'timeFrame': '12 hours', 'description': 'The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 12 hours after surgery'}, {'measure': 'Postoperative Nausea or vomiting M24', 'timeFrame': '24 hours', 'description': 'The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 24 hours after surgery'}, {'measure': 'Postoperative Nausea or vomiting M48', 'timeFrame': '48 hours', 'description': 'The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Patient demographic data', 'timeFrame': 'Before surgery', 'description': 'With a questionnaire will be studied the variables: age, sex, weight, height, BMI'}, {'measure': 'Surgical Duration', 'timeFrame': 'First hour after surgery', 'description': 'Time of surgery'}, {'measure': 'Duration of postoperative anesthesia stay', 'timeFrame': 'First hours after surgery', 'description': 'Time to postoperative anesthesia care unit discharge alive (hours)'}, {'measure': 'The length of stay in hospital', 'timeFrame': 'From end of surgery until hospital discharge or 30 days after surgery', 'description': 'Time of stay in hospital'}, {'measure': 'Time to request the first medication for nausea and vomiting', 'timeFrame': 'First hour after surgery', 'description': 'Reported by the patient or by a healthcare provider'}, {'measure': 'Amount of medication', 'timeFrame': 'During the first 30 days after surgery', 'description': 'Reported by a healthcare provider'}, {'measure': 'Postoperative complications', 'timeFrame': 'During the first 30 days after surgery', 'description': 'Postoperative complications after surgery'}, {'measure': 'Degree of patient satisfaction', 'timeFrame': 'Before discharge', 'description': "The patient's overall satisfaction will be assessed using point scales (very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Complications', 'Nausea', 'Vomiting'], 'conditions': ['Postoperative Complications', 'Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '24356162', 'type': 'RESULT', 'citation': 'Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.'}, {'pmid': '16679671', 'type': 'RESULT', 'citation': 'Pandey CK, Priye S, Ambesh SP, Singh S, Singh U, Singh PK. Prophylactic gabapentin for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. J Postgrad Med. 2006 Apr-Jun;52(2):97-100.'}, {'pmid': '26991615', 'type': 'RESULT', 'citation': 'Grant MC, Lee H, Page AJ, Hobson D, Wick E, Wu CL. The Effect of Preoperative Gabapentin on Postoperative Nausea and Vomiting: A Meta-Analysis. Anesth Analg. 2016 Apr;122(4):976-85. doi: 10.1213/ANE.0000000000001120.'}, {'pmid': '22156268', 'type': 'RESULT', 'citation': 'Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it becomes important the adequate control of PONV, aiming at the satisfaction of the patient with the procedure, lower costs for the health system as well as reduction of complications in the postoperative period. This study aims to evaluate the association of gabapentin or pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess side effects.', 'detailedDescription': 'The study included 60 patients at high risk for PONV (Apfel-score 0, I, II, III and IV) scheduled for elective laparoscopic surgeries at the Central Surgical Center of Irmandade da Santa Casa de Misericórdia in São Paulo. Inclusion criteria will be ASA I or II of either sex, in the age range of 18 to 70 years. In this study, the recruited patients will be allocated randomly into three groups. The group A will receive oral 600 mg gabapentin 2 h before surgery. The group B will receive oral 150 mg pregabalin 2 h before surgery. The Group C will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery. This study is "double-blind", in which neither the doctor nor the patient knows what medicine is being given.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing laparoscopic procedures\n* Apfel Score 0, I, II, III and IV\n* ASA I / II\n\nExclusion Criteria:\n\n* Patients with surgery converted to open before thirty minutes of surgery\n* Patients who were exposed previously to gabapentin or pregabalin Patients who have allergy to any medicine used in the study\n* Patient who have to any cognitive impairment\n* Illiterate patients\n* Patients who refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT03202459', 'briefTitle': 'Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}, 'officialTitle': 'Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery', 'orgStudyIdInfo': {'id': '56057116.0.0000.5479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Group A - gabapentin', 'description': 'The patient will receive oral 600 mg gabapentin 2 h before surgery', 'interventionNames': ['Drug: Group A - gabapentin 600 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Group B - pregabalin', 'description': 'The patient will receive oral pregabalin 150 mg 2 h before surgery', 'interventionNames': ['Drug: Group B - pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: Group C - placebo', 'description': 'The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery', 'interventionNames': ['Drug: Group C - placebo']}], 'interventions': [{'name': 'Group A - gabapentin 600 mg', 'type': 'DRUG', 'description': 'The patient will receive oral 600 mg gabapentin 2 h before surgery', 'armGroupLabels': ['Active Comparator: Group A - gabapentin']}, {'name': 'Group B - pregabalin', 'type': 'DRUG', 'description': 'The patient will receive oral pregabalin 150 mg 2 h before surgery', 'armGroupLabels': ['Active Comparator: Group B - pregabalin']}, {'name': 'Group C - placebo', 'type': 'DRUG', 'description': 'The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery', 'armGroupLabels': ['Placebo Comparator: Group C - placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01221-020', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Thiago Ramos Grigio, Master', 'role': 'CONTACT', 'email': 'grigiotr@gmail.com', 'phone': '+55 11 99298-1605'}, {'name': 'Ligia Andrade da Silva Telles Mathias, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Patrícia Mara Beltrame, Medical Residency', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rodolfo Brito Maia, Medical Residency', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paulo Henrique Borges Teixeira Lima, Medical Residency', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Irmandade da Santa Casa de Misericórdia de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Ligia Andrade da Silva Telles Mathias, Doctor', 'role': 'CONTACT', 'email': 'rtimao@uol.com.br', 'phone': '+ 55 11 99386-0059'}, {'name': 'Thiago Grigio, Master', 'role': 'CONTACT', 'email': 'grigiotr@gmail.com', 'phone': '+55 11 99298-1605'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Lígia Andrade da Silva Telles mathias', 'investigatorAffiliation': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}}}}