Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-30 @ 10:22 AM
Study NCT ID:
NCT02561494
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2015-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesic Effect of Nefopam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009340', 'term': 'Nefopam'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D010079', 'term': 'Oxazocines'}, {'id': 'D001392', 'term': 'Azocines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2015-08-02', 'studyFirstSubmitQcDate': '2015-09-24', 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day', 'timeFrame': 'postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day'}], 'secondaryOutcomes': [{'measure': 'Change of the pain score from postoperative 6 h to postoperative 5 day', 'timeFrame': 'postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day'}]}, 'conditionsModule': {'conditions': ['Stomach Neoplasms']}, 'descriptionModule': {'briefSummary': 'Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the total intravenous anesthesia (TIVA).\n\nThe investigators will evaluate whether the nefopam can decrease the total amount of remifentanil administered during the operation, which will reduce the acute opioid tolerance and following consumption of fentanyl during postoperative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Early or advanced gastric cancer\n\nExclusion Criteria:\n\n* Refusal\n* Use of preoperative analgesic drugs\n* Pregnancy\n* Recurred gastric cancer\n* Seizure\n* Cardiac disease\n* Monoamine oxidase inhibitor\n* Urologic disease\n* Previous intrabdominal surgery\n* Body mass index \\> 30 or \\< 16'}, 'identificationModule': {'nctId': 'NCT02561494', 'briefTitle': 'Postoperative Analgesic Effect of Nefopam', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'orgStudyIdInfo': {'id': 'Nefo_stomach op'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Intravenous normal saline 2 ml is given slowly as a placebo before the anesthesia induction and after finishing anesthesia.', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Nefopam', 'description': 'Intravenous nefopam 20 mg is given slowly before the anesthesia induction and after finishing anesthesia.', 'interventionNames': ['Drug: Nefopam']}], 'interventions': [{'name': 'Nefopam', 'type': 'DRUG', 'armGroupLabels': ['Nefopam']}, {'name': 'Saline', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-607', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Hyo-Seok Na', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}