Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-01-17 @ 2:41 PM
Study NCT ID:
NCT05529004
Status:
UNKNOWN
Last Update Posted:
2022-09-06
First Post:
2022-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D020706', 'term': 'Laparoscopes'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Double Blind study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2022-08-30', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.', 'timeFrame': 'Baseline', 'description': 'Analysis of pregabalin group compare with the control group in laparoscopic cholecystectomy patients. to fined effective of oral pregapaline on PONV. we assess the incidence of postoperative nausea and vomiting by the use of Koivuranta Score.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['nausea, vomiting, cholecystectomy, oral pregapalin'], 'conditions': ['Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '15064261', 'type': 'BACKGROUND', 'citation': 'Habib AS, Gan TJ. Evidence-based management of postoperative nausea and vomiting: a review. Can J Anaesth. 2004 Apr;51(4):326-41. doi: 10.1007/BF03018236.'}, {'pmid': '8669567', 'type': 'BACKGROUND', 'citation': 'Koivuranta MK, Laara E, Ryhanen PT. Antiemetic efficacy of prophylactic ondansetron in laparoscopic cholecystectomy. A randomised, double-blind, placebo-controlled trial. Anaesthesia. 1996 Jan;51(1):52-55. doi: 10.1111/j.1365-2044.1996.tb07654.x.'}, {'pmid': '32467512', 'type': 'BACKGROUND', 'citation': 'Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.'}, {'pmid': '16846542', 'type': 'RESULT', 'citation': 'Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis. Curr Med Res Opin. 2006 Jun;22(6):1093-9. doi: 10.1185/030079906X104830.'}, {'pmid': '7986507', 'type': 'RESULT', 'citation': 'Carroll NV, Miederhoff PA, Cox FM, Hirsch JD. Costs incurred by outpatient surgical centers in managing postoperative nausea and vomiting. J Clin Anesth. 1994 Sep-Oct;6(5):364-9. doi: 10.1016/s0952-8180(05)80004-2.'}, {'pmid': '17885699', 'type': 'RESULT', 'citation': 'Metz A, Hebbard G. Nausea and vomiting in adults--a diagnostic approach. Aust Fam Physician. 2007 Sep;36(9):688-92.'}]}, 'descriptionModule': {'briefSummary': 'As long as anesthesia is administered, postoperative nausea and vomiting (PONV) will continue to be a frequent and upsetting comorbidity. Vomiting and nausea can significantly slow down recovery, raise staffing and drug expenses, and decrease patient satisfaction during perioperative procedures.\n\nNausea it is a conscious recognition of subconscious excitation in area of medulla closely associated with or a part of the vomiting center, or it is sensation of discomfort at upper abdomen and unease sensation with involuntary order to vomit. While vomiting It is a mean by which the upper GIT rides of its contents when any part of upper GIT becomes irritated, over distended or over excitable.\n\nThe PONV is the most feared postoperative symptoms \\& it may impaired dressing , surgical repairs \\& increased ( bleeding , pain , risk of gastric contents aspiration ) \\& if it is prolonged will leads to electrolytes , fluid imbalance \\& dehydration ; the PONV can occurs after up to 90 % of operative procedures ; The common risk factors of PONV are : young age , female gender, history of ( PONV , motion sickness ) , those not smokers , early mobilization after surgery , early drinking \\& eating after operations , procedures like (laparoscopic , gynecological , abdominal , ENT , squint ) , postoperative severe pain , narcotic premedication , possibly prolonged general anesthesia , gastric distention , stimulation of the pharynx , hypoxemia , hypotension , \\& dehydration.\n\nThe PONV can reduced by: avoidance of triggers where possible, uses of anti-emetics drugs, techniques \\& procedures associated with low incidence of PONV (e.g. propofol) \\& give intravenous fluids; with prophylaxis the incidence is usually under 30% in high risk cases, the most effective approach for prevention of PONV is the use of multiple strategies \\& different drugs.\n\nThe pregabalin (C8H17NO2), is a newer drug \\& recently introduced at 1990. as anticonvulsive medication. We evaluated the effect of oral pregabalin on postoperative nausea and vomiting in laparoscopic cholecystectomy cases.', 'detailedDescription': "Pregabalin has been found to minimize the need for opioid as well as non-steroid anti-inflammatory medications and relieve pain with different type of surgery, along with consideration of a diverse mechanisms, preoperative oral pregabalin has been reported to have antiemetic effect postoperatively. postoperative laparoscopic cholecystectomy, are associated with nausea and Vomiting and it's a concern that dictates the need for antiemetic which gives intravenously; as the intravenous drugs with intravenous fluid is becoming more common, the use of oral pregabalin is frequently mentioned, on the other hand, the intravenous antiemetic medication has some side effect.\n\nAim of the study:\n\nTo evaluate the effect of oral pregabalin on postoperative nausea and vomiting in laparoscopic cholecystectomy cases.\n\nDesign: Randomized Double Blind study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 - \\< 55 years.\n* Both gender (male \\& female).\n* Patients ASA physical status1.\n* Procedures with high risk of postoperative nausea \\& vomiting.\n* Elective operations under general anesthesia with laparoscopic cholecystectomy.\n\nExclusion Criteria:\n\n* Age ≥ 55 years.\n* Emergency operations,\n* Patient refusal, allergy to pregabalin.\n* Pregnant patients, patients taken preoperative anti-emetic medications.\n* Patients with cardiac respiratory endocrine diseases.\n* Total intravenous maintenance general anesthesia and thiopental as induction agent.'}, 'identificationModule': {'nctId': 'NCT05529004', 'briefTitle': 'A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Al Safwa University College'}, 'officialTitle': 'Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.', 'orgStudyIdInfo': {'id': 'pregabalin and PONV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preoperative pregabalin to prevent postoperative nausea & vomiting in laparoscopic surgery.', 'description': 'participants receive pregapalin 75mg cap orally 30 min before surgery', 'interventionNames': ['Drug: Oral Capsule pregapalin', 'Device: laparoscope device']}, {'type': 'NO_INTERVENTION', 'label': 'placebo', 'description': "participants hasn't receive pregapalin capsule"}], 'interventions': [{'name': 'Oral Capsule pregapalin', 'type': 'DRUG', 'otherNames': ['general anesthesia'], 'description': 'oral cap of pregapalin has been administration to patient before surgery to prvent PONV', 'armGroupLabels': ['Preoperative pregabalin to prevent postoperative nausea & vomiting in laparoscopic surgery.']}, {'name': 'laparoscope device', 'type': 'DEVICE', 'description': 'general anesthesia with complete relaxation under laparoscopic cholecystectomy', 'armGroupLabels': ['Preoperative pregabalin to prevent postoperative nausea & vomiting in laparoscopic surgery.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohammed abdulzahra sasaa, phd', 'role': 'CONTACT', 'email': 'm.abedalzahraa@alsafwa.edu.iq', 'phone': '009647718991533', 'phoneExt': 'AZ'}, {'name': 'Ahmed AN sahib, phd', 'role': 'CONTACT', 'email': 'smralmmwry@gmail.com', 'phone': '009647815759208'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al Safwa University College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthetist', 'investigatorFullName': 'Mohammed AbdulZahra Sasaa', 'investigatorAffiliation': 'Al Safwa University College'}}}}