Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 5:58 PM
Study NCT ID:
NCT05785234
Status:
UNKNOWN
Last Update Posted:
2023-03-27
First Post:
2023-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Sufentanil vs. Remifentanil in Total Intravenous Anesthesia With Remimazolam on Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total consumption of fentanyl in 24 hours after surgery', 'timeFrame': 'after 24 hours postoperative period', 'description': 'To investigate the effect of total intravenous anesthesia with intraoperative sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain, total cumulative dose of fentanyl was measured for the first postoperative 24 hour.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stomach Neoplasms']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators evaluate the effect of total intravenous anesthesia using sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain in patients undergoing laparoscopic gastrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 20years or older\n2. Scheduled for laparoscopic-assisted gastrectomy\n3. American Society of Anesthesiologists(ASA) physical status I and III\n\nExclusion Criteria:\n\n1. Emergency operation\n2. Patients with a history of severe hypersensitivity reaction to dextran 40\n3. Patients who cannot use patient controlled analgesia(PCA)\n4. Patients with morbid obesity \\[body mass index (BMI) \\>35 kg/m2\\]\n5. Patients with history of uncontrolled hypertension (diastolic BP \\>110mmHg) or DM\n6. Patients with history of heart failure (unstable angina, congestive heart failure)\n7. Patients with history of liver failure, renal failure, allergic to medicine\n8. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)\n9. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)\n10. Patients with obstructive sleep apnea\n11. Patients who cannot read the consent form (examples: Illiterate, foreigner)\n12. Patients who withdraw the consent'}, 'identificationModule': {'nctId': 'NCT05785234', 'briefTitle': 'The Effects of Sufentanil vs. Remifentanil in Total Intravenous Anesthesia With Remimazolam on Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy - A Randomized, Controlled Study-', 'orgStudyIdInfo': {'id': '4-2022-1606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sufentanil-remimazolam group', 'description': 'The sufentanil-remimazolam group receives total intravenous anesthesia with sufentanil-remimazolam.', 'interventionNames': ['Drug: sufentanil-remimazolam group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remifentanil-remimazolam group', 'description': 'The remifentanil-remimazolam group receives total intravenous anesthesia with remifentanil-remimazolam.', 'interventionNames': ['Drug: remifentanil-remimazolam group']}], 'interventions': [{'name': 'sufentanil-remimazolam group', 'type': 'DRUG', 'description': 'Induction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 0.5 ng·ml-1 of sufentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 0.2 - 0.6 ng·ml-1 of sufentanil.', 'armGroupLabels': ['Sufentanil-remimazolam group']}, {'name': 'remifentanil-remimazolam group', 'type': 'DRUG', 'description': 'Induction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 4 ng·ml-1 of remifentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 2-6 ng·ml-1 of remifentanil.', 'armGroupLabels': ['Remifentanil-remimazolam group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sun Joon Bai', 'role': 'CONTACT', 'email': 'SJBAE@yuhs.ac', 'phone': '82-2-2228-4438'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sun Joon Bai, MD, PhD', 'role': 'CONTACT', 'email': 'SJBAE@yuhs.ac', 'phone': '82-2-2228-4438'}], 'overallOfficials': [{'name': 'Sun Joon Bai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}