Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 5:28 AM
Study NCT ID:
NCT04239794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-22
First Post:
2020-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Type of Anesthesia on Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2020-01-21', 'studyFirstSubmitQcDate': '2020-01-21', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative 24 h opioid consumption', 'timeFrame': '24 hours after the surgery', 'description': 'Cumulative opioid consumption for pain control 24 hours after the surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative 48 h opioid consumption', 'timeFrame': '48 hours after the surgery', 'description': 'Cumulative opioid consumption for pain control 48 hours after the surgery'}, {'measure': 'Numerical rating scale (NRS)', 'timeFrame': '24 and 48 hours after the surgery', 'description': 'Numerical rating scale (NRS) pain score 24 and 48 hours after the surgery. NRS is an 11-point scale for patient self-reporting of pain; 0-10 where 0 is no pain and 10 is the worst pain imaginable.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Opioid consumption', 'Intraoperative anesthesia'], 'conditions': ['Colo-rectal Cancer', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '30075537', 'type': 'BACKGROUND', 'citation': 'Wong SSC, Choi SW, Lee Y, Irwin MG, Cheung CW. The analgesic effects of intraoperative total intravenous anesthesia (TIVA) with propofol versus sevoflurane after colorectal surgery. Medicine (Baltimore). 2018 Aug;97(31):e11615. doi: 10.1097/MD.0000000000011615.'}]}, 'descriptionModule': {'briefSummary': 'The investigators designed a multi-center prospective randomized controlled trial to study the influence of the type of anesthesia on postoperative pain after laparoscopic colorectal cancer surgery. Half of the participants will be anesthetized with propofol and remifentanil, while the other half will be anesthetized with sevoflurane and remifentanil during the surgery. The investigators will measure opioid consumption and pain score in the acute postoperative phase.', 'detailedDescription': 'Previous studies showed that patients receiving total intravenous anesthesia (TIVA) with propofol are associated with less postoperative pain and less opioid consumption compared with inhalation anesthesia. However, some studies showed conflicting results. In colorectal surgery, there are only retrospective studies that showed the analgesic effect of TIVA and inhalation anesthesia. The investigators designed a multi-center prospective randomized controlled trial and hypothesized that TIVA with propofol would be associated with reduced postoperative opioid consumption and less postoperative pain compared with sevoflurane in laparoscopic colorectal cancer surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient scheduled for elective laparoscopic colorectal cancer surgery\n\nExclusion Criteria:\n\n* Pregnant\n* Conversion from laparoscopic to open surgery\n* Allergy to anesthetics and analgesics\n* Previous abdominal surgery\n* Chronic pain\n* Chronic analgesic usage'}, 'identificationModule': {'nctId': 'NCT04239794', 'briefTitle': 'The Influence of Type of Anesthesia on Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Influence of Type of Anesthesia on Postoperative Pain After Laparoscopic Colorectal Cancer Surgery: Multi-center Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'TIVA-IA-Pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Inhalation anesthesia', 'description': 'Patients are anesthetized with sevoflurane and remifentanil infusion for maintenance of anesthesia during the surgery', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Total intravenous anesthesia', 'description': 'Patients are anesthetized with target-controlled intravenous infusion of propofol and remifentanil infusion for maintenance of anesthesia during the surgery', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Propofol 2%'], 'description': 'General anesthesia during the laparoscopic colorectal surgery is achieved by using a target-controlled intravenous infusion of propofol.', 'armGroupLabels': ['Total intravenous anesthesia']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevoflurane inhalant product'], 'description': 'General anesthesia during the laparoscopic colorectal surgery is achieved by using an inhalation agent (Sevoflurane).', 'armGroupLabels': ['Inhalation anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '13620', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor (full)', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}