Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-03-18 @ 10:52 PM
Study NCT ID:
NCT03685032
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2018-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery
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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study drugs based on a sequentially numbered list were prepared in the same way. These drugs had similar characteristics, including clear color and no observable particles, and were loaded into syringes labeled for each group. The attending anesthesiologists, anesthetic nurses, and ward nurses, as well as the patients were blinded to the computer-generated randomization lists.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blinded randomized control trial was conducted. The investigators allocated patients into two arm.\n\nThe study group (Gr. D) received intraoperative dexamethasone 4 mg iv and ondansetron 4 mg iv, whereas the control group (Gr. N) received placebo (0.9% normal saline 1 ml iv and 0.9% normal saline 2 ml iv)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2016-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2018-09-23', 'studyFirstSubmitQcDate': '2018-09-24', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in incidence of postoperative nausea and vomiting', 'timeFrame': 'The incidence was recorded at 1 hour as a baseline and changing incidences from baseline were recorded at 2 hours, 4 hours, and 24 hours.', 'description': 'Postoperative nausea and vomiting events was recorded by blinded anesthesiologists, blinded anesthetic nurses, and blinded ward nurses.'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'The intensity of pain was recorded at 1 hour and 2 hours in the postoperative period in the recovery room and at 4 hours and 24 hours in the ward.', 'description': 'The intensity of postoperative pain was measured with a numeric rating scale (NRS: 0=no pain, 10=severe pain)'}, {'measure': 'opioid analgesics consumed', 'timeFrame': 'The opioid analgesics used was recorded at 1 hour and 2 hours in the postoperative period in the recovery room and at 4 hours and 24 hours in the ward.', 'description': 'opioid analgesics consumed was recorded by blinded anesthesiologists, blinded anesthetic nurses, and blinded ward nurses.'}, {'measure': 'severity of postoperative nausea and vomiting', 'timeFrame': 'The severity of postoperative nausea and vomiting was recorded at 1 hour and 2 hours in the postoperative period in the recovery room and at 4 hours and 24 hours in the ward.', 'description': 'Severity of postoperative nausea and vomiting was recorded by blinded anesthesiologists, blinded anesthetic nurses, and blinded ward nurses. Level of severity of PONV (0=no symptoms; 1=mild: few symptoms and not requiring treatment; 2=moderate: presented symptoms and needed ondansetron 8 mg iv; 3=severe: persisted symptoms after received ondansetron 8 mg iv and needed re-administration of ondansetron 8 mg iv)'}, {'measure': 'Antiemetics used', 'timeFrame': 'The antiemetic used was recorded at 1 hour and 2 hours in the postoperative period in the recovery room and at 4 hours and 24 hours in the ward.', 'description': 'Antiemetics used was recorded by blinded anesthesiologists, blinded anesthetic nurses, and blinded ward nurses.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microvascular Decompression Surgery', 'Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '26257852', 'type': 'BACKGROUND', 'citation': 'Ha SH, Kim H, Ju HM, Nam DJ, Min KT. Comparison of the antiemetic effect of ramosetron with ondansetron in patients undergoing microvascular decompression with retromastoid craniotomy: a preliminary report. Korean J Anesthesiol. 2015 Aug;68(4):386-91. doi: 10.4097/kjae.2015.68.4.386. Epub 2015 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative nausea and vomiting (PONV) is a common problem and may lead to catastrophic complications, especially in neurosurgical cases. The aim of this study was to evaluate the effects of dexamethasone and ondansetron for preventing PONV in patients who underwent microvascular decompression surgery (MVD).', 'detailedDescription': 'A prospective, double-blinded randomized control trial was conducted with 54 patients who underwent MVD. Patients were allocated into two groups. The study group (Gr. D) received intraoperative dexamethasone 4 mg iv and ondansetron 4 mg iv, whereas the control group (Gr. N) received placebo (0.9% normal saline 1 ml iv and 0.9% normal saline 2 ml iv). The incidence and severity of PONV were observed at 1, 2, 4 and 24 hr post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were scheduled for MVD of trigeminal nerve root\n* Patients who had a physical status classification of I to III according to the American Society of Anesthesiologists, and those who had a body mass index of 18 to 35 kg/m2\n\nExclusion Criteria:\n\n* Patients on long-term administration of dexamethasone or ondansetron, those with a history of allergic reactions to dexamethasone or ondansetron, those who had undergone antiemetic therapy within 24 hr before surgery, those with underlying liver or renal failure, those who were pregnant, or those who had undergone emergency surgery.'}, 'identificationModule': {'nctId': 'NCT03685032', 'briefTitle': 'Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'HE571218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The study group (Gr. D)', 'description': 'After patients received general anesthesia, a sequentially numbered opaque sealed envelope was opened. Gr. D was administered 4 mg of dexamethasone in 1 ml iv.\n\nAt the end of the operation when suturing the dura mater, Gr. D received ondansetron 4 mg in 2 ml iv.', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Ondansetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'the control group (Gr. N)', 'description': 'After patients received general anesthesia, a sequentially numbered opaque sealed envelope was opened. Gr. N received normal saline 1 ml iv.\n\nAt the end of the operation when suturing the dura mater, Gr. N received normal saline 2 ml iv.', 'interventionNames': ['Drug: 0.9% Sodium Chloride Injection']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Lodexa'], 'description': 'The 4 mg of dexamethasone in 1 ml intravenous was administrated after patient received general anesthesia', 'armGroupLabels': ['The study group (Gr. D)']}, {'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Onsia'], 'description': 'The 4 mg of ondansetron in 2 ml intravenous was administrated at the end of the operation.', 'armGroupLabels': ['The study group (Gr. D)']}, {'name': '0.9% Sodium Chloride Injection', 'type': 'DRUG', 'description': 'The 0.9% sodium chloride in 1 ml intravenous was administrated after patient received general anesthesia. At the end of operation, the 0.9% sodium chloride in 2 ml intravenous was administrated.', 'armGroupLabels': ['the control group (Gr. N)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Pornthep Kasemsiri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Khon Kaen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Pornthep Kasemsiri', 'investigatorAffiliation': 'Khon Kaen University'}}}}