Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT06990893
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2025-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C586842', 'term': '((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'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': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2025-05-18', 'studyFirstSubmitQcDate': '2025-05-18', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The VAS pain scores at rest and during exercise of the three groups of patients after the operation', 'timeFrame': 'at 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the operation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sufentanil', 'Safety', 'Morphine', 'oliceridine'], 'conditions': ['Sufentanil', 'Morphine', 'Validity', 'Safety', 'Oliceridine']}, 'descriptionModule': {'briefSummary': 'Objective: To compare the application of oxelidine in postoperative analgesia after orthopedic lumbar spine surgery with morphine or sufentanil, and to explore the efficacy and safety of postoperative analgesia.\n\nMethod: Researchers included 90 patients with American Society of Anesthesiologists (ASA) physical conditions I and III, aged 18 to 65 years, who were scheduled to undergo orthopedic lumbar general anesthesia surgery at an appropriate time. The patients were randomly divided into 3 groups, with 30 cases in each group: The oxeridine group (Group A), where a loading dose of 1.5mg of oxeridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01mg/kg-1.h-1 was connected. Oxeridine was mixed with normal saline to 100ml at a rate of 2ml/h. Morphine group (Group M), a loading dose of 4mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03mg.kg-1.h-1 morphine was connected with normal saline to 100ml at a rate of 2ml/h. Sufentanil group (Group S), a 4u loading dose of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03ug.kg-1.h-1 was connected. Sufentanil was combined with normal saline to 100ml at a rate of 2ml/h.The resting and exercise VAS pain scores of the three groups of patients at 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the operation and adverse reactions within 48 hours were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lumbar spine surgery with ASA grades I-III\n* Aged 18-65 years\n* Ethically, the patient voluntarily accepted this trial and signed the informed consent form\n\nExclusion Criteria:\n\n* Severe respiratory and circulatory system diseases\n* Nervous system disease\n* Mental and psychological disorders\n* Abnormal liver and kidney functions\n* Participated in another drug clinical research within the past 30 days'}, 'identificationModule': {'nctId': 'NCT06990893', 'briefTitle': 'Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Anqing Municipal Hospital'}, 'officialTitle': 'Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'Sun Ling'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The oliceridine group(A)', 'description': 'A loading dose of 1.5mg of oliceridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01 mg.kg-1.h-1 orselidine was connected and diluted with normal saline to 100ml at a rate of 2ml per hour', 'interventionNames': ['Drug: Oliceridine']}, {'type': 'EXPERIMENTAL', 'label': 'The morphine group(M)', 'description': 'A loading dose of 4mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump was connected to 0.03mg.kg-1.h-1 morphine mixed with normal saline to 100ml at a rate of 2ml per hour', 'interventionNames': ['Drug: Morphine']}, {'type': 'EXPERIMENTAL', 'label': 'The sufentanil group(S)', 'description': 'A loading dose of 4ug of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03ug.kg-1.h-1 was connected. Sufentanil was mixed with normal saline to 100ml at a rate of 2ml per hour', 'interventionNames': ['Drug: Sufentanil']}], 'interventions': [{'name': 'Oliceridine', 'type': 'DRUG', 'description': 'a loading dose of 1.5 mg of oliceridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01 mg.kg-1.h-1 oliceridine was connected with normal saline to 100 ml at a rate of 2 ml per hour', 'armGroupLabels': ['The oliceridine group(A)']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'a loading dose of 4 mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03 mg.kg-1.h-1 morphine was connected with normal saline to 100 ml at a rate of 2 ml per hour', 'armGroupLabels': ['The morphine group(M)']}, {'name': 'Sufentanil', 'type': 'DRUG', 'description': 'A 4 ug loading dose of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03 ug.kg-1 h-1 was connected. sufentanil was mixed with normal saline to 100 ml at a rate of 2 ml per hour', 'armGroupLabels': ['The sufentanil group(S)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '246003', 'city': 'Anqing', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Department of Anqing Hospital Anesthesiology', 'geoPoint': {'lat': 30.51365, 'lon': 117.04723}}], 'centralContacts': [{'name': "Sun Ling Lu Sun Ling LU, Master's degree", 'role': 'CONTACT', 'email': '348092640@qq.com', 'phone': '15955565806'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anqing Municipal Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}