Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-02-12 @ 5:26 AM
Study NCT ID:
NCT06787404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2024-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Post-Induction Hypotension Treatment with PRAM Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004809', 'term': 'Ephedrine'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Is there a difference in the need for repeated doses of treatments to reach the target blood pressure in patients who develop post-induction hypotension?"', 'timeFrame': 'First 30 minutes after anesthesia induction or time to skin incision', 'description': 'When hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed how many hypotension episodes occured after treatment'}, {'measure': '"Is there a difference in the time to reach the target blood pressure after treatments in patients who develop post-induction hypotension?"', 'timeFrame': 'First 30 minutes after anesthesia induction or time to skin incision', 'description': 'When hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed that is there a difference in the time to reach the target blood pressure after treatments'}], 'secondaryOutcomes': [{'measure': 'Systemic vascular resistance (SVR)', 'timeFrame': 'First 30 minutes after anesthesia induction or time to skin incision', 'description': 'To examine the effects of the applied treatments on the systemic vascular resistance from the PRAM method and compare them with each other.'}, {'measure': 'Arterial Elastance (Ea)', 'timeFrame': 'First 30 minutes after anesthesia induction or time to skin incision', 'description': 'To examine the effects of the applied treatments on the Ea from the PRAM method and compare them with each other.'}, {'measure': 'Cardiac Output (CO)', 'timeFrame': 'First 30 minutes after anesthesia induction or time to skin incision', 'description': 'To examine the effects of the applied treatments on the CO from the PRAM method and compare them with each other.'}, {'measure': 'Stroke Volume (SV)', 'timeFrame': 'First 30 minutes after anesthesia induction or time to skin incision', 'description': 'To examine the effects of the applied treatments on the SV from the PRAM method and compare them with each other.'}, {'measure': 'Cardiac Cycle Efficiency (CCE)', 'timeFrame': 'First 30 minutes after anesthesia induction or time to skin incision', 'description': 'To examine the effects of the applied treatments on the CCE from the PRAM method and compare them with each other.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-induction Hypotension', 'PRAM', 'Ephedrine', 'Noradrenaline'], 'conditions': ['Hypotension on Induction']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases. The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases.', 'detailedDescription': 'Post-induction hypotension is defined as hypotension that occurs within the first 20-30 minutes after general anesthesia induction or during the period between anesthesia induction and surgical incision. The global incidence rates are reported to be approximately 10.3%, with some studies indicating rates as high as 66.96%. Post-induction hypotension is associated with increased postoperative morbidity risks, such as acute kidney injury, transient tubular dysfunction, myocardial injury, and the need for postoperative intensive care. However, hypotension is a modifiable and preventable risk factor; its early detection and appropriate treatment can improve patient outcomes.\n\nFor this reason, investigators aimed to investigate the repeated dose requirements of alpha-adrenergic drugs, the recurrence of hypotension, and their effects on parameters observed via the MostCare monitor in patients undergoing major gynecologic oncologic surgeries during standard anesthesia induction and maintenance. This investigation focuses on patients experiencing a mean arterial pressure \\<65 mmHg or a \\>30% reduction in baseline systolic blood pressure within the first 30 minutes after induction or until surgical incision. Additionally, our secondary aim is to examine other parameters that may be associated with post-induction hypotension.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators choose Gynecological Oncology patients who will operated for gyno-oncological reasons', 'genderDescription': 'Since our study is conducted on gynecologic oncology patients, all of our patients are women.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 18 years old\n* Operated for Gynecologic Oncological reasons\n* BMI\\<35\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Additional spinal or epidural anesthesia\n* Dementia patients from whom consent could not be obtained\n* Atrial fibrillation with a rapid ventricular response\n* Patients with difficult ventilation and/or difficult intubation\n* Left ventricular ejection fraction (EF) below 30%\n* Severe aortic valve stenosis\n* Obesity (BMI \\>35)\n* Chronic beta-blocker use'}, 'identificationModule': {'nctId': 'NCT06787404', 'briefTitle': 'Evaluation of Post-Induction Hypotension Treatment with PRAM Method', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Evaluation of Post-Induction Hypotension Treatment with PRAM Method Data in Gynecologic Oncology Cases', 'orgStudyIdInfo': {'id': 'E2-23-5996'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ephedrine', 'description': 'When post-induction hypotension occurred patients were treated with 5 milligrams ephedrine in this group. If blood pressure does not reach desired levels, same dosage will be repeated 5 minutes later from administration. Maximum 3 doses will be applied and if hypotension ist persist the treatment will changed to rescue treatment.', 'interventionNames': ['Drug: Ephedrine']}, {'label': 'Noradrenaline', 'description': 'When post-induction hypotension occurred patients were treated with 5 micrograms noradrenaline in this group. If blood pressure does not reach desired levels, same dosage will be repeated 5 minutes later from administration. Maximum 3 doses will be applied and if hypotension ist persist the treatment will changed to rescue treatment.', 'interventionNames': ['Drug: Noradrenalin']}], 'interventions': [{'name': 'Ephedrine', 'type': 'DRUG', 'otherNames': ['Ephedrine Group'], 'description': '5 milligrams of ephedrine will be applied when post-induction hypotension occured. After 3 doses, dose will be increased or changed to other treatment options.', 'armGroupLabels': ['Ephedrine']}, {'name': 'Noradrenalin', 'type': 'DRUG', 'otherNames': ['Noradrenalin Group'], 'description': '5 micrograms of ephedrine will be applied when post-induction hypotension occured. After 3 doses, dose will be increased or changed to other treatment options.', 'armGroupLabels': ['Noradrenaline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06660', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent Şehir Hastanesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Akgün E Şarer, Ass. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}