Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-01 @ 7:04 AM
Study NCT ID:
NCT04700761
Status:
UNKNOWN
Last Update Posted:
2022-07-05
First Post:
2020-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid-free Anesthesia in Gynecologic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-01', 'studyFirstSubmitDate': '2020-10-19', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intra-operative blood pressure', 'timeFrame': 'Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay)', 'description': 'Blood pressure (mmHg)'}, {'measure': 'Intra-operative heart rate', 'timeFrame': 'Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay)', 'description': 'Heart rate (bpm)'}, {'measure': 'Hemodynamic drug intervention', 'timeFrame': 'Intra-operative, day of surgery(during PACU stay)', 'description': 'Number of intervention'}], 'primaryOutcomes': [{'measure': 'Total incidence of post-operative nausea', 'timeFrame': 'up to post-operative day 2', 'description': 'Y/N'}], 'secondaryOutcomes': [{'measure': 'Incidence of post-operative nausea', 'timeFrame': 'day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2', 'description': 'Y/N'}, {'measure': 'Severity of post-operative nausea', 'timeFrame': 'day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2', 'description': 'Grading: none, mild, moderate, severe'}, {'measure': 'Incidence of post-operative retching/vomiting', 'timeFrame': 'day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2', 'description': 'Y/N'}, {'measure': 'Rescue antiemetic agent use', 'timeFrame': 'day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2', 'description': 'Number of administration'}, {'measure': 'Post-operative pain score', 'timeFrame': 'day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2', 'description': 'Grading: 11-point numeric pain scale (0-10, 10 means the worst pain)'}, {'measure': 'Rescue pain medication use', 'timeFrame': 'day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2', 'description': 'Number of administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Analgesics, opioid', 'Postoperative nausea', 'Laparoscopy', 'Gynecologic surgical procedures'], 'conditions': ['Gynecologic Disease']}, 'descriptionModule': {'briefSummary': 'Post-operative nausea and vomiting (PONV) is common for the patients undergoing laparoscopic gynecologic surgery. PONV is a major factor for patient dissatisfaction, delayed patient recovery and increased medical expenses. Opioid-reducing anesthetic regimen is known to decrease PONV and facilitate early recovery after surgery (ERAS) and has been widely accepted recently. In this study, the researchers intend to investigate whether opioid-free anesthesia effectively reduces PONV, and whether it is clinically safe and feasible.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for laparoscopic gynecologic surgery (≥90 min) for benign or malignant uterine/ovarian disease\n* Age ≥ 19\n* ASA (American Society of Anesthesiologists) class I-II\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Untreated intracranial aneurysm\n* Severely impaired renal or hepatic function\n* Pregnancy\n* History of hypersensitivity for drugs used in the study\n* Patients not using NSAID-containing IV PCA (patient controlled analgesia) device post-operatively'}, 'identificationModule': {'nctId': 'NCT04700761', 'briefTitle': 'Opioid-free Anesthesia in Gynecologic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Effect of Opioid-free General Anesthesia on Postoperative Nausea and Vomiting in Laparoscopic Gynecologic Surgery', 'orgStudyIdInfo': {'id': 'B-2006-619-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group OFA (Opioid-free anesthesia)', 'description': 'Not using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (except a single dose of alfentanil for endotracheal intubation)', 'interventionNames': ['Procedure: Opioid-free anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group OUA (Opioid-using anesthesia)', 'description': 'Using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (continuous infusion of remifentanil)', 'interventionNames': ['Procedure: Opioid-using anesthesia']}], 'interventions': [{'name': 'Opioid-free anesthesia', 'type': 'PROCEDURE', 'description': 'Anesthesia induction: thiopental, rocuronium, desflurane + single dose of alfentanil for endotracheal intubation Anesthesia maintenance: desflurane (without any opioid) Rescue for hypertension, tachycardia: desflurane and beta blocker/calcium channel blocker', 'armGroupLabels': ['Group OFA (Opioid-free anesthesia)']}, {'name': 'Opioid-using anesthesia', 'type': 'PROCEDURE', 'description': 'Anesthesia induction: thiopental, rocuronium, desflurane + continuous infusion of remifentanil (TCI, Minto model) Anesthesia maintenance: desflurane, remifentanil Rescue for hypertension, tachycardia: desflurane, remifantanil and beta blocker/calcium channel blocker', 'armGroupLabels': ['Group OUA (Opioid-using anesthesia)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyo-Seok Na', 'role': 'CONTACT', 'email': 'hsknana@gmail.com', 'phone': '1087012913'}], 'facility': 'Seoul National Univ. Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Hyo-Seok Na', 'role': 'CONTACT', 'email': 'hsknana@gmail.com', 'phone': '+821087012913'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Hyo-Seok Na', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}