Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-23 @ 1:14 PM
Study NCT ID:
NCT06784258
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-20
First Post:
2025-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Inflammatory Factors, Pain Scale, and Postoperative Recovery Quality (QOR - 15) in Patients Undergoing Colorectal Cancer Surgery with Conventional General Anesthesia Techniques Compared to General Anesthesia Combined with Epidural Anesthesia At Prof. Ngoerah Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], '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'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D000767', 'term': 'Anesthesia, Epidural'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Colorectal patient undergoing elective surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduce Interleukin 6 differences', 'timeFrame': 'before surgery and 6 hours after surgery', 'description': 'Interleukin 6 will be collected before surgery and 6 hours after surgery by the anesthesiologist in the Operating theatre.'}], 'secondaryOutcomes': [{'measure': 'Reduce VAS pain scale', 'timeFrame': '24 Hours', 'description': 'VAS scale will be collected by the anesthesiologist in charge of the patient 24 hours after surgery'}, {'measure': 'Increase Quality of Recovery - 15', 'timeFrame': '24 Hours', 'description': 'QOR-15 score will be collected by the anesthesiologist in charge of the patient 24 hours after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epidural anesthesia', 'interleukin 6', 'postoperative pain', 'colorectal cancer', 'regional anesthesia', 'Quality of Recovery-15'], 'conditions': ['Inflammation Biomarkers', 'Quality of Recovery (QoR-15)', 'Visual Analog Pain Scale']}, 'descriptionModule': {'briefSummary': 'Surgery can increase IL-6 cytokines, triggering inflammation and metastasis. The combination of general and epidural anesthesia has the potential to suppress IL-6, improve the tumor microenvironment, provide analgesia, and enhance postoperative recovery.\n\nObjectives :To compare the effectiveness of postoperative analgesia quality in colorectal cancer patients receiving general anesthesia combined with epidural anesthesia.', 'detailedDescription': 'Patients will be divided into 2 groups: Group P (treatment) and Group K (control).\n\nBefore anesthesia, 2-3 mL of blood will be collected by the researcher from patients in both groups using a red tube.\n\nPatients in the control group will undergo conventional general anesthesia. Patients in the treatment group will undergo conventional general anesthesia combined with epidural anesthesia. Patients will be administered 0.25% Bupivacaine local anesthetic incrementally until the desired volume is achieved based on the targeted segmental block height.\n\nSix hours postoperatively, 2-3 mL of blood will be collected, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 - 65 years\n* Patients with ASA physical status I - III\n\nExclusion Criteria:\n\n* Patients with contraindications to regional anesthesia\n\n * Patients with mental disorders or psychiatric disorders\n * The patient has a history of allergy to the local anesthetic used.\n * The patient or family refuses to take part in the study\n * BMI \\> 30 Kg/m2'}, 'identificationModule': {'nctId': 'NCT06784258', 'briefTitle': 'Comparison of Inflammatory Factors, Pain Scale, and Postoperative Recovery Quality (QOR - 15) in Patients Undergoing Colorectal Cancer Surgery with Conventional General Anesthesia Techniques Compared to General Anesthesia Combined with Epidural Anesthesia At Prof. Ngoerah Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Udayana University'}, 'officialTitle': 'Comparison of Inflammatory Factors, Pain Scale, and Postoperative Recovery Quality (QOR - 15) in Patients Undergoing Colorectal Cancer Surgery with Conventional General Anesthesia Techniques Compared to General Anesthesia Combined with Epidural Anesthesia At Prof. Ngoerah Hospital', 'orgStudyIdInfo': {'id': '3005/UN14.2.2.VII.14/LT/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group : Conventinal General Anesthesia', 'description': 'Patients in the control group will undergo conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg body weight, propofol 2-3 mg/kg body weight, and a muscle relaxant for intubation, such as atracurium 0.5 mg/kg body weight or rocuronium 0.6 mg/kg body weight. Afterward, the patient will undergo intubation. Before anesthesia, 2-3 mL of blood will be collected. After the operation is complete the patient will be extubated and blood samples will be taken 6 hours after surgery, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively. The patient will be given opioid analgesics (Morphine dose 0.5-1 mg/hour given continuously or Fentanyl dose 10-50/hour mcg given continuously), Ketorolac 30 mg every 8 hours intravenously and Paracetamol 500 mg every 6 hours orally', 'interventionNames': ['Procedure: General Anesthesia (control group)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group : Conventinal General Anesthesia Combine with Epidural Anesthesia', 'description': 'Patients in the experimental group will undergo conventional general anesthesia combine with epidural anesthesia. The patient will undergo epidural anesthesia first with an epidural catheter, the general anesthesia with intravenous fentanyl 1-2 mcg/kg body weight, propofol 2-3 mg/kg body weight, and a muscle relaxant for intubation, such as atracurium 0.5 mg/kg body weight or rocuronium 0.6 mg/kg body weight. Afterward, the patient will undergo intubation. Before anesthesia, 2-3 mL of blood will be collected. After the operation is complete the patient will be extubated and blood samples will be taken 6 hours after surgery, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively. The patietn will be given Epidural analgesic Bupivacaine 0.1% + Morphine 0.5 mg volume 10 mL every 12 hours, Ketorolac 30 mg every 8 hours + Paracetamol 500 mg every 6 hours orally', 'interventionNames': ['Procedure: General Anesthesia combined with epidural anesthesia']}], 'interventions': [{'name': 'General Anesthesia (control group)', 'type': 'PROCEDURE', 'description': 'The patient will undergo conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg BW, propofol 2-3 ml/kg BW, and muscle relaxants for intubation, such as atracurium 0.5 mg/kg BW or rocuronium 0.6 mg/kg BB. After that the patient will be intubated', 'armGroupLabels': ['Control Group : Conventinal General Anesthesia']}, {'name': 'General Anesthesia combined with epidural anesthesia', 'type': 'PROCEDURE', 'description': 'The patient will undergo epidural anesthesia first with an epidural catheter inserted through a Tuohy needle and ensuring that the length of the multihole epidural catheter that enters the epidural space is 5-6 cm. After that, the patient underwent conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg BW, propofol 2-3 ml/kg BW, and muscle relaxants for intubation, such as atracurium 0.5 mg/kg BW or rocuronium 0.6 mg/ kg BW. After that the patient will be intubated. The patient will be given local anesthesia Bupivacaine 0.25% in increments to the desired volume according to the desired height of the segmental block. Local anesthetic medication will be given intermittently every 2 hours', 'armGroupLabels': ['Experimental Group : Conventinal General Anesthesia Combine with Epidural Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denpasar', 'state': 'Bali', 'country': 'Indonesia', 'facility': 'Anesthesiology and Intensive Therapy Udayana University', 'geoPoint': {'lat': -8.65, 'lon': 115.21667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Udayana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Jimmy Wongkar', 'investigatorAffiliation': 'Udayana University'}}}}