Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-26 @ 1:37 PM
Study NCT ID:
NCT00738192
Status:
COMPLETED
Last Update Posted:
2009-03-11
First Post:
2008-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia
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': 'D005283', 'term': 'Fentanyl'}, {'id': 'D017409', 'term': 'Sufentanil'}, {'id': 'D002077', 'term': 'Butorphanol'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-10', 'studyFirstSubmitDate': '2008-08-18', 'studyFirstSubmitQcDate': '2008-08-18', 'lastUpdatePostDateStruct': {'date': '2009-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS ratings of pain', 'timeFrame': '0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia'}], 'secondaryOutcomes': [{'measure': 'Hemodynamics of patients', 'timeFrame': '30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation'}, {'measure': 'Sedative ratings with VAS system', 'timeFrame': '0,5,10,15,25,45 and 60min after awake from anesthesia'}, {'measure': 'Overall VAS satisfaction ratings', 'timeFrame': '1 h after operation'}, {'measure': 'Blood cortisol and β-endorphin levels', 'timeFrame': '0, 10min before the end of surgeries, 10min, 1h and 6h after operation'}, {'measure': 'Side effects', 'timeFrame': '1 h after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postoperative analgesia', 'Opioids', 'Laparoscopic surgery'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': "Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. In addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. How to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. This study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA physical status I-II\n2. Chinese\n3. 19-45yr\n4. Selective laparoscopic surgeries\n\nExclusion Criteria:\n\n1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records\n2. Participants younger than 18 years, older than 45 years or pregnancy was eliminated\n3. Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study\n4. Those who were not willing to or could not finish the whole study at any time'}, 'identificationModule': {'nctId': 'NCT00738192', 'acronym': 'CARAN', 'briefTitle': 'Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries', 'orgStudyIdInfo': {'id': 'NMU-FY2008-311'}, 'secondaryIdInfos': [{'id': 'NJFY0807311M'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Fentanyl delivered for controlling awaking pain', 'interventionNames': ['Drug: Fentanyl citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Sufentanil delivered for controlling awaking pain', 'interventionNames': ['Drug: Sufentanil citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Butorphanol delivered for controlling awaking pain', 'interventionNames': ['Drug: Butorphanol tartrate']}], 'interventions': [{'name': 'Fentanyl citrate', 'type': 'DRUG', 'otherNames': ['Fentanil'], 'description': 'Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished', 'armGroupLabels': ['1']}, {'name': 'Sufentanil citrate', 'type': 'DRUG', 'otherNames': ['Sufenil'], 'description': 'Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished', 'armGroupLabels': ['2']}, {'name': 'Butorphanol tartrate', 'type': 'DRUG', 'otherNames': ['Nuoyung'], 'description': 'Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210004', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'XiaoFeng Shen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'XiaoFeng Shen', 'oldOrganization': 'Nanjing Medical University'}}}}