Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:47 AM
Study NCT ID:
NCT07307495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-29
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 428}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-12-14', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'posoperative 48 hours', 'description': 'Incidence of nausea and vomiting within 48 hours after surgery, proportion of patients requiring rescue antiemetics within 48 hours, and the amount of rescue antiemetics used within 48 hours'}], 'primaryOutcomes': [{'measure': 'Proportion of patients reaching the GI-3 composite endpoint within postoperative 24 hours', 'timeFrame': 'postoperative 24 hours', 'description': 'Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 24 hours'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients reaching the GI-3 composite endpoint within postoperative 48 hours', 'timeFrame': 'postoperative 48 hours', 'description': 'Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 48 hours'}, {'measure': 'GI-3', 'timeFrame': 'postoperative 48 hours', 'description': 'GI-3: Reach the later of the following two milestones:\n\n① Time of solid food tolerance: No vomiting occurs within 4 hours after eating food that requires chewing ;\n\n② Time of first flatus or first bowel movement (whichever comes first).'}, {'measure': 'IFEED score', 'timeFrame': 'postoperative 24 and 48 hours', 'description': 'IFEED scores at postoperative 24 and 48 hours The I-FEED score is a novel outcome measure for POI, developed by expert consensus. It contains five elements (intake, response to nausea treatment, emesis, exam, and duration, each scored with 0, 1, or 3 points) and classifies patients into normal, postoperative gastrointestinal intolerance (POGI), and postoperative gastrointestinal dysfunction (POGD)(normal 0-2, POGI 3-5, POGD 6+ points)'}, {'measure': 'Postoperative SPID', 'timeFrame': 'postoperative 24 and 48 hours', 'description': 'Summed Pain Intensity Difference at postoperative 24 and 48 hours'}, {'measure': 'Opioid consumption', 'timeFrame': 'postoperative 24 and 48 hours', 'description': 'Opioid consumption at postoperative 24 and 48 hours'}, {'measure': 'remedial analgesia', 'timeFrame': 'postoperative 48 hours', 'description': 'Times of remedial analgesia at postoperative 48 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lumbar spine surgery', 'gastrointestinal function recovery'], 'conditions': ['Oliceridine Fumarate']}, 'descriptionModule': {'briefSummary': 'Osemitidine fumarate is a novel G protein-biased ligand μ-opioid receptor agonist. Previous studies have confirmed its potent analgesic effects and safety: compared with morphine, it reduces respiratory depression and gastrointestinal dysfunction. This study aims to evaluate the effects of osemitidine on postoperative gastrointestinal function recovery and pain in patients undergoing lumbar spine surgery through a multicenter, double-blind, randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 75 years old;\n* Patients undergoing lumbar surgery under general anesthesia (within 3 segments) and expected to receive postoperative patient-controlled analgesia;\n* ASA classification I-III;\n* BMI between 18 and 30 kg/m²;\n* Informed consent obtained from the patient.\n\nExclusion Criteria:\n\n* Use of any painkillers within 3 days before surgery; or long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), defined as: within 3 months before surgery, use of NSAIDs daily for more than 2 consecutive weeks;\n* Presence of intestinal obstruction or suspicious symptoms: nausea and vomiting, abdominal bloating and pain, cessation of gas or bowel movements within the past two weeks, imaging suggesting intestinal dilation, or large amounts of air-fluid levels;\n* Patients with severe liver dysfunction (based on Child-Pugh classification, grade C);\n* History of or planned gastrointestinal surgery;\n* Patients allergic to the study drug;\n* Pregnant or breastfeeding patients;\n* QTcF abnormalities, males \\>450 ms, females \\>470 ms;\n* Participation in other drug trials within the past 30 days;\n* Long-term use of opioids (defined as: within 12 months before surgery, use for more than 1 month, more than 3 days per week, with daily doses exceeding 15 mg morphine equivalent);\n* Pre-existing neurological or psychiatric disorders: such as epilepsy, depression, schizophrenia, etc.;\n* Patients deemed unsuitable for this study by the investigator.'}, 'identificationModule': {'nctId': 'NCT07307495', 'briefTitle': 'Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery:A Prospective, Multicenter, Double-blind,Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'KY20252506-F-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oliceridine Group', 'description': 'Oliceridine Patient-Controlled Analgesia Pump After Lumbar Spine Surgery', 'interventionNames': ['Drug: Oiceridine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sufentanil Group', 'description': 'Sufentanil Patient-Controlled Analgesia Pump After Lumbar Spine Surgery', 'interventionNames': ['Drug: Sufentanil']}], 'interventions': [{'name': 'Sufentanil', 'type': 'DRUG', 'description': 'The postoperative PCA analgesia pump configuration plan is 1.5 μg/kg sufentanil diluted with saline to 100 ml.\n\nThe specific parameters are a loading dose: 0.1 μg/kg sufentanil diluted with saline to 3 ml, administered 20-30 minutes before the end of surgery.\n\nBackground infusion rate: 1.5 ml/h, PCA dose: 1 ml, lockout time: 10 minutes.', 'armGroupLabels': ['Sufentanil Group']}, {'name': 'Oiceridine', 'type': 'DRUG', 'description': 'The postoperative PCA analgesic pump regimen is 0.5 mg/kg of oliceridine diluted with saline to 100 ml. The specific parameters are a loading dose: 0.03 mg/kg of Oxycodone diluted with saline to 3 ml, administered 20-30 minutes before the end of surgery. Background infusion rate: 1.5 ml/h, PCA dose: 1 ml, lockout interval: 10 minutes.', 'armGroupLabels': ['Oliceridine Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hailong Dong', 'role': 'CONTACT', 'email': 'hldong369@hotmail.com', 'phone': '13669226699'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}