Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT00155233
Status:
UNKNOWN
Last Update Posted:
2005-11-23
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interaction Between Nalbuphine and Morphine in PCA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009266', 'term': 'Nalbuphine'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-06', 'lastUpdateSubmitDate': '2005-11-22', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2005-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analgesic effect'}], 'secondaryOutcomes': [{'measure': 'incidence of opioid-related side effects'}]}, 'conditionsModule': {'keywords': ['analgeisa', 'postoperatve', 'side effects'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': '1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist\n2. This study was designed to investigate the interaction between nalbuphine and morphine', 'detailedDescription': '1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist\n2. This study was designed to investigate the interaction between nalbuphine and morphine\n3. The analgesic effect and opioid-related side effects will be investigated'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-65 y/o\n2. Female patients of ASA physical status I to III\n3. Scheduled for elective abdominal hysterectomy, myomectomy, or excision of ovarian tumor\n\nExclusion Criteria:\n\n1. Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants)\n2. Intraoperative fentanyl use \\> 3 μg/kg\n3. Patients with definite diagnosis of esophageal reflux syndrome\n4. Use of sedatives, antiemetics, or antipruritics within 24 hours before operation\n5. Surgery \\> 4 hours or laparoscopy surgery'}, 'identificationModule': {'nctId': 'NCT00155233', 'briefTitle': 'Interaction Between Nalbuphine and Morphine in PCA', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Interaction Between Nalbuphine and Morphine in Postoperative PCA for Gynecologic Patients', 'orgStudyIdInfo': {'id': '931002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nalbuphine and morphine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu Chang Yeh, MD', 'role': 'CONTACT', 'email': 'cooltony@ha.mc.ntu.edu.tw'}, {'name': 'Wei-Zen Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Wei-Zen Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}}}}