Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT07097220
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2025-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Different Anesthetic Techniques on Intraoperative and Postoperative Pain Levels and Cognitive Function in Patients Undergoing Hepatectomy for Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intraoperative Analgesic Adequacy', 'timeFrame': 'Entire surgical duration', 'description': 'Percentage of patients with:\n\nGrade I (adequate) vs\n\nGrades II-IV (inadequate) analgesia (Per Supplementary Table S1 criteria)'}, {'measure': 'Surgical Stress Correlation', 'timeFrame': 'Intraoperative period', 'description': 'Pearson correlation coefficients between:\n\nAnesthesia technique (GA/GEA)\n\nBlood loss (mL)\n\nSurgery duration (min)'}], 'primaryOutcomes': [{'measure': 'Postoperative Cognitive Dysfunction (POCD)', 'timeFrame': 'Baseline (preoperative), POD1 (24±4h), POD3 (72±6h)', 'description': 'Percentage of patients with:\n\nMoCA score \\<26 at postoperative assessment OR\n\n≥2-point decrease from preoperative baseline (Assessed using Montreal Cognitive Assessment, 30-point scale)'}, {'measure': 'Postoperative Pain Intensity', 'timeFrame': '2h, 6h, 12h, 24h, 48h postoperatively', 'description': 'Mean pain scores measured by:\n\nVisual Analog Scale (VAS)\n\n10cm scale (0=no pain, 10=worst pain)'}], 'secondaryOutcomes': [{'measure': 'Intraoperative Opioid Consumption', 'timeFrame': 'Anesthesia induction to extubation', 'description': 'Total remifentanil dose administered:\n\nMeasured in micrograms (μg)\n\nRecorded from anesthesia machine'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'Up to 30 days post-surgery', 'description': 'Duration from surgery end to discharge:\n\nMeasured in days\n\nFrom electronic medical records'}, {'measure': 'Adverse Event Incidence', 'timeFrame': '0-72 hours postoperatively', 'description': 'Percentage of patients with:\n\nNausea/vomiting\n\nDelirium (CAM-positive)\n\nOther complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cancer', 'Hepatectomy', 'Anesthesia Techniques', 'Postoperative Pain', 'Cognitive Dysfunction', 'Epidural-general Anesthesia']}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of general anesthesia (GA) versus combined general and epidural anesthesia (GEA) on postoperative pain, cognitive dysfunction (POCD), hospital stay, and recovery quality in liver cancer patients undergoing hepatectomy.\n\nA retrospective analysis of 80 liver cancer patients was conducted, categorized by analgesic adequacy, pain recovery, and POCD incidence: adequate vs. inadequate analgesia (n=50 vs. n=30), favorable vs. delayed pain recovery (n=36 vs. n=44), and POCD vs. non-POCD (n=42 vs. n=38). Based on these results, a prospective study (April 2024-April 2025) enrolled patients scheduled for elective hepatectomy, assigned to the GA group (n=59) or GEA group (n=47). Primary outcomes included intraoperative analgesic consumption, postoperative VAS pain scores, MoCA cognitive scores, hospital stay length, and adverse event rates.', 'detailedDescription': 'Compared to GA alone, combined epidural-general anesthesia provides better perioperative pain control, reduces POCD risk, shortens hospitalization, and enhances recovery. GEA is a preferable anesthetic approach for liver cancer surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n* Histologically or radiologically confirmed primary liver cancer (HCC or cholangiocarcinoma)\n* Scheduled for elective open or laparoscopic radical hepatectomy\n* Age 18-75 years\n* ASA Physical Status I-III\n* Child-Pugh class A or B liver function\n* Normal preoperative MoCA score (≥26)\n* Willing to participate and provide informed consent\n* Exclusion Criteria:\n* Severe cardiovascular, pulmonary or renal disease (ASA IV/V)\n* Chronic pain disorders or preoperative opioid use (\\>3 months)\n* Known neurologic/psychiatric conditions (dementia, stroke, epilepsy)\n* Concurrent major procedures (e.g., vascular resection)\n* Intraoperative conversion to palliative surgery\n* Massive intraoperative hemorrhage (\\>2000 mL)\n* Coagulopathy (INR \\>1.5 or platelets \\<50×10⁹/L)\n* Spinal abnormalities precluding epidural catheterization\n* Pregnancy or lactation\n* Allergy to local anesthetics or study medications'}, 'identificationModule': {'nctId': 'NCT07097220', 'briefTitle': 'Effects of Different Anesthetic Techniques on Intraoperative and Postoperative Pain Levels and Cognitive Function in Patients Undergoing Hepatectomy for Liver Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sir Run Run Shaw Hospital, Qingchun Campus, Zhejiang University School of Medicine,'}, 'officialTitle': 'Effects of Different Anesthetic Techniques on Intraoperative and Postoperative Pain Levels and Cognitive Function in Patients Undergoing Hepatectomy for Liver Cancer', 'orgStudyIdInfo': {'id': 'No. 2025-0355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'general anesthesia group', 'description': 'In the General Anesthesia (GA) group (n = 59), patients received combined intravenous-inhalation general anesthesia. Anesthesia induction was performed using propofol and remifentanil, followed by maintenance with sevoflurane to ensure adequate anesthetic depth and hemodynamic stability throughout the procedure.', 'interventionNames': ['Drug: General Anesthesia (GA) group']}, {'type': 'EXPERIMENTAL', 'label': 'General-Epidural Anesthesia group', 'description': 'In the General-Epidural Anesthesia (GEA) group (n = 47), patients received the same general anesthesia protocol as the GA group, in addition to epidural anesthesia. An epidural catheter was placed preoperatively at the T7-T9 vertebral level using a midline approach under strict aseptic conditions. Following successful catheterization and confirmation of proper placement, a continuous intraoperative infusion of 0.25% ropivacaine was administered via the epidural route to provide segmental analgesia and reduce intraoperative opioid requirements.', 'interventionNames': ['Drug: General-Epidural Anesthesia (GEA) group']}], 'interventions': [{'name': 'General Anesthesia (GA) group', 'type': 'DRUG', 'description': 'In the General Anesthesia (GA) group (n = 59), patients received combined intravenous-inhalation general anesthesia. Anesthesia induction was performed using propofol and remifentanil, followed by maintenance with sevoflurane to ensure adequate anesthetic depth and hemodynamic stability throughout the procedure.', 'armGroupLabels': ['general anesthesia group']}, {'name': 'General-Epidural Anesthesia (GEA) group', 'type': 'DRUG', 'description': 'In the General-Epidural Anesthesia (GEA) group (n = 47), patients received the same general anesthesia protocol as the GA group, in addition to epidural anesthesia. An epidural catheter was placed preoperatively at the T7-T9 vertebral level using a midline approach under strict aseptic conditions. Following successful catheterization and confirmation of proper placement, a continuous intraoperative infusion of 0.25% ropivacaine was administered via the epidural route to provide segmental analgesia and reduce intraoperative opioid requirements.', 'armGroupLabels': ['General-Epidural Anesthesia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310015', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital, Qingchun Campus, Zhejiang University School of Medicine,', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Juhui Chen', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}