Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00199303
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Pre- and Post-Operative Oral Dextromethorphan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-07', 'completionDateStruct': {'date': '2003-12'}, 'lastUpdateSubmitDate': '2005-09-12', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean morphine consumption'}, {'measure': 'Mean pain score'}]}, 'conditionsModule': {'keywords': ['NMDAreceptor antagonist, dextromethorphan', 'pain, post-operative', 'opioid consumption, morphine'], 'conditions': ['Efficacy of Dextromethorphan', 'Morphine Consumption', 'Pain']}, 'descriptionModule': {'briefSummary': 'We studied the effect of dextromethorphan (DEX), an N-methyl-d-aspartate antagonist, on analgesic consumption and pain scoring after abdominal hysterectomy. Our aim was to compare the analgesic effectiveness and incidence of adverse side effects of oral DEX with placebo (P)', 'detailedDescription': 'One hundred patients were randomized to two groups. Group DEX was given 30 mg tablets of oral dextromethorphan with their pre-medication and three more times in the first 24 hours after surgery. Group P received the placebo following the same schedule. Post-operative analgesic requirements were assessed using a patient-controlled analgesia system.\n\nPain was assessed at rest using a visual analog scale in the post anesthetic care unit(PACU), 6 and 24 hours after surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged between 30 and 60, with an ASA physical status of I or II, undergoing elective total abdominal hysterectomy under general anesthesia.\n\nExclusion Criteria:\n\n* Women with a history of significant renal or hepatic impairment, allergy to any of the study medications, antitussive or NSAID use (48 hours or 1 week, respectively) before surgery, chronic pain and regular analgesic use, were excluded. Patients taking medications that could interact with dextromethorphan, including quinidine, flecainide, mexiletine, fluoxetine, amitriptyline, nortriptyline, and propafenone'}, 'identificationModule': {'nctId': 'NCT00199303', 'briefTitle': 'Efficacy of Pre- and Post-Operative Oral Dextromethorphan', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Efficacy of Pre- and Post-Operative Oral Dextromethorphan for Reduction of Intra- and 24-Hr Post-Operative Morphine Consumption for Transabdominal Hysterectomy', 'orgStudyIdInfo': {'id': 'efficacy of dextromethorphan'}, 'secondaryIdInfos': [{'id': 'KhonKaen University'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'pre-operatively followed by 30 mg three times per day after surgery', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'KhonKaen', 'state': 'KhonKaen', 'country': 'Thailand', 'facility': 'Waraporn Chau-in'}], 'overallOfficials': [{'name': 'waraporn chau-in, Asso Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand'}, {'name': 'BUSABONG SUKMOUEN, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology'}, {'name': 'KRIANGSAK NGAMSANGSIRISAPT, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology'}, {'name': 'WINITA JIRARAREUNGSAK', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}}}}