Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-07 @ 9:03 PM
Study NCT ID:
NCT01930318
Status:
UNKNOWN
Last Update Posted:
2014-11-10
First Post:
2013-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance After Gastrointestinal Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C409945', 'term': 'parecoxib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-07', 'studyFirstSubmitDate': '2013-08-25', 'studyFirstSubmitQcDate': '2013-08-27', 'lastUpdatePostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery', 'timeFrame': '5 days after operation'}], 'secondaryOutcomes': [{'measure': 'The consumption of total and incremental tramadol after surgery.', 'timeFrame': '5 days after operation'}, {'measure': 'The tolerated dose of enteral nutrition every day after surgery', 'timeFrame': '5 days after operation'}, {'measure': 'Postoperative inflammatory factors (IL-4, IL-6 and TNF-α) and levels of stress hormone (glucocorticoids and catecholamines) in perioperative period of gastrointestinal laparoscopic surgery', 'timeFrame': '5 days after operation'}, {'measure': 'Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients', 'timeFrame': '5 days after operation'}, {'measure': 'The time of the first bowel movements and anal exhaust time after surgery', 'timeFrame': '5 days after operation or more'}, {'measure': 'Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale', 'timeFrame': '5 days after operation'}, {'measure': 'Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus', 'timeFrame': '5 days after operation or more'}, {'measure': 'Liver and renal function tests in perioperative period', 'timeFrame': '5 days after operation'}, {'measure': 'Self-rating anxiety scale and self-rating questionnaire for depression before surgery', 'timeFrame': '1 day before surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastrointestinal Cancer']}, 'referencesModule': {'references': [{'pmid': '23328338', 'type': 'BACKGROUND', 'citation': 'Xu Z, Li Y, Wang J, Li J. Effect of postoperative analgesia on energy metabolism and role of cyclooxygenase-2 inhibitors for postoperative pain management after abdominal surgery in adults. Clin J Pain. 2013 Jul;29(7):570-6. doi: 10.1097/AJP.0b013e318270f97b.'}]}, 'descriptionModule': {'briefSummary': 'It is well established that the resistance to the effects of insulin on glucose metabolism develops with a lot of stress hormone release after surgical trauma. This condition is known as insulin resistance (IR) characterized by hyperglycemia, hyperinsulinemia and lactic acidosis. Surgical IR not only affect glucose metabolism but also influence protein synthesis, then further exacerbate the depletion of the carbohydrate, fat and protein.\n\nPostoperative pain is a challenging task for patients and surgeons, and it is part of the stress response to trauma and surgery, while the fear of pain can exacerbate the stress response.\n\nThe main aim of this study was to invest whether effective postoperative analgesia can reduce the stress response and insulin resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with gastrointestinal cancer scheduled for gastrointestinal laparoscopic surgery\n* Patients between the ages of 18 and 70 yr\n* ASA physical status I-II\n* Requirements of informed consent and assent of participant, parent or legal guardian as applicable\n* Consciousness and ability to cooperate\n\nExclusion criteria：\n\n* History of alcohol, analgesic, or narcotic abuse\n* Used analgesics, neuroleptics, antipsychotic agents, or corticosteroids within 6 hours of surgery\n* A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease\n* Female with positive pregnancy\n* Allergy to conventional NSAIDs'}, 'identificationModule': {'nctId': 'NCT01930318', 'briefTitle': 'Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance After Gastrointestinal Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance, Tramadol PCA and Early Postoperative Enteral Nutrition in Patients After Gastrointestinal Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'PTP-IR-EEN-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PCA,Placebo,Placebo', 'description': 'PCA for 2 days after operation, i.v placebo in 2 days after surgery and oral placebo in the day 3 to day 5 after surgery'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PCA,placebo,tramadol', 'description': 'PCA for 2 days after operation, i.v placebo in 2 days after surgery, and oral tramadol in the day 3 to day 5 after surgery'}, {'type': 'EXPERIMENTAL', 'label': 'PCA,parecoxib,placebo', 'description': 'PCA for 2 days after operation, i.v parecoxib in 2 days after surgery,and oral placebo in the day 3 to day 5 after surgery', 'interventionNames': ['Drug: parecoxib']}, {'type': 'EXPERIMENTAL', 'label': 'PCA,parecoxib,celecoxib', 'description': 'PCA for 2 days after operation,i.v parecoxib in 2 days after surgery and oral celecoxib in the day 3 to day 5 after surgery', 'interventionNames': ['Drug: parecoxib']}], 'interventions': [{'name': 'parecoxib', 'type': 'DRUG', 'otherNames': ['COX-2 selective inhibitors'], 'description': '4 groups: PCA,Placebo,Placebo-PCA for 2 days after operation, i.v placebo in 2 days after surgery and oral placebo in the day 3 to day 5 after surgery; PCA,placebo,tramadol-PCA for 2 days after operation, i.v placebo in 2 days after surgery, and oral tramadol(0.1g t.i.d.) in the day 3 to day 5 after surgery;PCA,parecoxib,placebo-PCA for 2 days after operation, i.v parecoxib(40mg b.i.d.) in 2 days after surgery,and oral placebo in the day 3 to day 5 after surgery;PCA,parecoxib,celecoxib-PCA for 2 days after operation,i.v parecoxib(40mg b.i.d.) in 2 days after surgery and oral celecoxib(0.2g b.i.d.) in the day 3 to day 5 after surgery', 'armGroupLabels': ['PCA,parecoxib,celecoxib', 'PCA,parecoxib,placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200002', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wencheng Kong, MD', 'role': 'CONTACT', 'email': 'wenchengkong@gmail.com', 'phone': '15850722032'}, {'name': 'Yousheng Li, MD', 'role': 'CONTACT', 'email': 'liys@medmail.com.cn'}, {'name': 'Wencheng Kong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Danhua Yao, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'lele Ren, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Wengcheng Kong, MD', 'role': 'CONTACT', 'email': 'wenchengkong@gmail.com', 'phone': '15850722032'}, {'name': 'Yousheng Li', 'role': 'CONTACT', 'email': 'liys@medmail.com.cn', 'phone': '8602580860137'}], 'overallOfficials': [{'name': 'Wencheng Kong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Resident', 'investigatorFullName': 'Kong Wencheng', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}