Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT06739460
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-18
First Post:
2024-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Antinociceptive Effects of Ketamine and Magnesium Used for Sedation in Hysteroscopy Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antinociceptive effects of ketamine and magnesium', 'timeFrame': 'During the hysteroscopic procedures.', 'description': 'Observe the effect of ketamine and magnesium use on total additional doses of propofol and additional doses of remifentanil.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnesium', 'Sedation', 'Hysteroscopi', 'Opioid', 'Pain'], 'conditions': ['Hysteroscopy']}, 'referencesModule': {'references': [{'pmid': '12393361', 'type': 'BACKGROUND', 'citation': 'Telci L, Esen F, Akcora D, Erden T, Canbolat AT, Akpir K. Evaluation of effects of magnesium sulphate in reducing intraoperative anaesthetic requirements. Br J Anaesth. 2002 Oct;89(4):594-8. doi: 10.1093/bja/aef238.'}, {'pmid': '32957926', 'type': 'BACKGROUND', 'citation': 'Gao PF, Lin JY, Wang S, Zhang YF, Wang GQ, Xu Q, Guo X. Antinociceptive effects of magnesium sulfate for monitored anesthesia care during hysteroscopy: a randomized controlled study. BMC Anesthesiol. 2020 Sep 21;20(1):240. doi: 10.1186/s12871-020-01158-9.'}, {'pmid': '32718032', 'type': 'BACKGROUND', 'citation': 'Shin HJ, Na HS, Do SH. Magnesium and Pain. Nutrients. 2020 Jul 23;12(8):2184. doi: 10.3390/nu12082184.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the antinociceptive effects of ketamine and magnesium used in addition to midazolam, fentanyl, propofol and remifentanil agents preferred in hysteroscopy cases. It is conducted to observe the effect of ketamine and magnesium use on total additional propofol doses and additional remifentanil doses.', 'detailedDescription': 'Sedation is generally preferred in hysteroscopy cases. The most commonly used intravenous drugs are midazolam, fentanyl, propofol and remifentanil. Multimodal analgesia, which is intended to be provided in hysteroscopy cases, is a strategy that includes the use of two or more analgesic agents and techniques to provide adequate analgesia; and aims to minimize side effects such as bradycardia, hypotension, respiratory depression, pruritus, and postoperative nausea and vomiting. Multimodal analgesia improves patient and surgical comfort by applying additional drugs to existing agents, reduces postoperative complications, and thus helps to shorten hospital stays and reduce costs. Whether magnesium contributes to this multimodal analgesia will be investigated observationally, based on its antinociceptive effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving sedation for gynecological hysteroscopic surgery in the gynecology operating room of Ankara Etlik City Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA I-II patients\n2. Patients aged 18-55\n3. Patients undergoing hysteroscopy\n\nExclusion Criteria:\n\n1. Patients who develop surgical complications during hysteroscopy\n2. Patients with cardiovascular failure (ejection fraction \\<40%, patients with atrioventricular conduction disorder\n3. Patients with history of cerebrovascular disease\n4. Liver dysfunction (transaminases above normal level), Renal failure (creatine \\> 150 μmol/L),\n5. Preoperative opioid use\n6. History of neuromuscular disease\n7. History of drug or alcohol abuse\n8. Patients who develop the need for endotracheal intubation'}, 'identificationModule': {'nctId': 'NCT06739460', 'briefTitle': 'Comparison of Antinociceptive Effects of Ketamine and Magnesium Used for Sedation in Hysteroscopy Cases', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'Comparison of Antinociceptive Effects of Ketamine and Magnesium Used for Sedation in Hysteroscopy Cases', 'orgStudyIdInfo': {'id': 'AEŞH-EK1-2024-0056'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'P group', 'description': 'This group consists of hysteroscopy cases in which sedation was given using fentanyl, midazolam, propofol and remifentanil.'}, {'label': 'K group', 'description': 'This group consists of hysteroscopy cases in which sedation was given using fentanyl, midazolam, ketamine, propofol and remifentanil.'}, {'label': 'KM group', 'description': 'This group consists of hysteroscopy cases that received preoperative magnesium sulfate and sedation using fentanyl, midazolam, ketamine, propofol and remifentanil.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Ankara', 'state': 'Yenimahalle', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SULEYMAN SARI', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'SULEYMAN SARI', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}