Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-03 @ 10:05 PM
Study NCT ID:
NCT03864094
Status:
COMPLETED
Last Update Posted:
2024-10-04
First Post:
2019-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004809', 'term': 'Ephedrine'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D010656', 'term': 'Phenylephrine'}, {'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077208', 'term': 'Remifentanil'}], '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'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization made by a person not involved in trial in other ways. Allocation masked in sealed envelopes, stored in a locked cash box only opened by two drug preparing nurses not involved in patient care. Syringe labelled with patient identification (ID) (eg 04Vaso). Patient, Care Provider and Investigator blinded for actual concentration of drug. Allocation break after data data wash and processing.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled, double-blind.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2019-03-02', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure (SBP)', 'timeFrame': 'First 7,5 minutes from start of induction', 'description': 'Change in SBP during induction as measured by the LiDCOplus monitoring system'}, {'measure': 'Heart Rate (HR)', 'timeFrame': 'First 7,5 minutes from start of induction', 'description': 'Change in HR during induction as measured by the LiDCOplus monitoring system'}], 'secondaryOutcomes': [{'measure': 'Stroke Volume (SV)', 'timeFrame': 'First 7,5 minutes from start of induction', 'description': 'Change in SV during induction as measured by the LiDCOplus monitoring system'}, {'measure': 'Cardiac Output (CO)', 'timeFrame': 'First 7,5 minutes from a start of induction', 'description': 'Change in CO during induction as measured by the LiDCOplus monitoring system'}, {'measure': 'Systemic Vascular Resistance (SVR)', 'timeFrame': 'First 7,5 minutes from start of induction', 'description': 'Change in SVR during induction as measured by the LiDCOplus monitoring system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Output (CO)', 'Systolic Blood Pressure (SBP)', 'Systemic Vascular Resistance (SVR)', 'Heart Rate (HR)', 'Stroke Volume (SV)', 'Lithium Dilutional Cardiac Output (LiDCO)', 'Minimal Invasive Hemodynamic Monitor', 'Propofol', 'Remifentanil', 'Ephedrine', 'Phenylephrine', 'Norepinephrine'], 'conditions': ['Hemodynamic Instability', 'Anesthesia, General', 'Anesthesia, Intravenous']}, 'referencesModule': {'references': [{'pmid': '1751277', 'type': 'BACKGROUND', 'citation': 'Fairfield JE, Dritsas A, Beale RJ. Haemodynamic effects of propofol: induction with 2.5 mg kg-1. Br J Anaesth. 1991 Nov;67(5):618-20. doi: 10.1093/bja/67.5.618.'}, {'pmid': '10844832', 'type': 'BACKGROUND', 'citation': 'Kazmaier S, Hanekop GG, Buhre W, Weyland A, Busch T, Radke OC, Zoelffel R, Sonntag H. Myocardial consequences of remifentanil in patients with coronary artery disease. Br J Anaesth. 2000 May;84(5):578-83. doi: 10.1093/bja/84.5.578.'}, {'pmid': '9771299', 'type': 'BACKGROUND', 'citation': 'Turner RJ, Gatt SP, Kam PC, Ramzan I, Daley M. Administration of a crystalloid fluid preload does not prevent the decrease in arterial blood pressure after induction of anaesthesia with propofol and fentanyl. Br J Anaesth. 1998 Jun;80(6):737-41. doi: 10.1093/bja/80.6.737.'}, {'pmid': '15449752', 'type': 'BACKGROUND', 'citation': 'Al-Ghamdi A. Hydroxyethylstarch 6% preload does not prevent the hypotension following induction with propofol and fentanyl. Middle East J Anaesthesiol. 2004 Jun;17(5):959-68.'}, {'pmid': '21196672', 'type': 'BACKGROUND', 'citation': 'El-Tahan MR. Preoperative ephedrine counters hypotension with propofol anesthesia during valve surgery: a dose dependent study. Ann Card Anaesth. 2011 Jan-Apr;14(1):30-40. doi: 10.4103/0971-9784.74397.'}, {'pmid': '24803761', 'type': 'BACKGROUND', 'citation': 'Masjedi M, Zand F, Kazemi AP, Hoseinipour A. Prophylactic effect of ephedrine to reduce hemodynamic changes associated with anesthesia induction with propofol and remifentanil. J Anaesthesiol Clin Pharmacol. 2014 Apr;30(2):217-21. doi: 10.4103/0970-9185.130024.'}, {'pmid': '41144827', 'type': 'DERIVED', 'citation': 'Sjoen GH, Hauge TH, Falk RS, Tonnessen TI, Langesaeter E. Haemodynamic Changes After Prophylactic Doses of Ephedrine, Phenylephrine, Norepinephrine Versus Placebo During Induction of General Anaesthesia: A Randomised Trial. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70138. doi: 10.1111/aas.70138.'}]}, 'descriptionModule': {'briefSummary': 'In this trial the investigators want to examine if there is any difference in hemodynamic stability when giving equipotent prophylactic injections of ephedrine 0,1 mg/kg, phenylephrine 1 microg/kg, norepinephrine 0,1 microg/kg or sodium chloride (NaCl) 9 mg/ml during induction of general anesthesia with propofol and remifentanil.', 'detailedDescription': 'The LiDCOplus monitoring system (Lithium Dilutional Cardiac Output (LiDCO) Ltd., Cambridge, United Kingdom) is a minimally invasive monitor for measuring stroke volume (SV) using two different algorithms. The PulseCO (PulseCO ™, Cambridge, United Kingdom) is based on analyses of the the arterial pressure wave giving nominal values. The LiDCO uses lithium-dilution for calibration to give absolute values. In this trial, the investigators will use the PulseCO looking at relative changes in uncalibrated hemodynamic variables. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured.\n\nEarlier studies have shown that propofol 2.5 mg/kg induction without opioid reduces CO (-15%), SV (-5 %), MAP (-33%) and SVR (-11%) and a slight reduction i HR. High-dose remifentanil anesthesia (2 microg/kg/min), in coronary patients reduced cardiac index (-25%), SV (-14%) and MAP (-39%) in a similar manner as propofol/remifentanil (propofol target 2 microg/ml and remifentanil 0.5 microg/kg/min), but systemic vascular resistance index decreased (-14%) in propofol/remifentanil combination.\n\nSeveral procedures have been proposed to minimize the negative hemodynamic changes during induction. Administration of a crystalloid or a colloid did not prevent the decrease in MAP after induction of general anesthesia with propofol and fentanyl.\n\nThe hemodynamic effects in propofol-fentanyl anesthesia of preoperative ephedrine 0.07-0.15 mg/kg vs phenylephrine 1.5 microg/kg in valve surgery and concludes that ephedrine 0.07-0.1 mg/kg is safe and effective in counteracting hypotension. A dose of 0.15 mg/kg ephedrine is suggested for preventing hypotension during anesthesia induction with propofol 2.5 mg/kg and remifentanil 3 microg/kg.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women\n* Age 18-50 years\n* Gynecological procedures\n* General anesthesia\n\nExclusion Criteria:\n\n* Pre-existing hypertension\n* Diabetes for several years\n* Ischemic heart disease\n* Cerebrovascular disease\n* Heart valve disease\n* Verified cardiac arrhythmia\n* Anaemia\n* Kidney or hepatic disease\n* Hypersensitivity for soya, eggs or peanuts\n* Pregnancy\n* Poor health state\n* Illicit substance use\n* BMI \\<20 or \\>35 kg/m2\n* SBP \\>150 mmHg\n* HR \\>100 beats/min'}, 'identificationModule': {'nctId': 'NCT03864094', 'acronym': 'VH', 'briefTitle': 'Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.', 'organization': {'class': 'OTHER', 'fullName': 'Helse Fonna'}, 'officialTitle': '"Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Equipotent Prophylactic Doses of Ephedrine, Phenylephrine, Norepinephrine vs Placebo."', 'orgStudyIdInfo': {'id': '2019/374'}, 'secondaryIdInfos': [{'id': '2019-000965-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ephedrine Propofol Remifentanil', 'description': 'Prophylactic Ephedrine', 'interventionNames': ['Drug: Ephedrine', 'Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phenylephrine Propofol Remifentanil', 'description': 'Prophylactic Phenylephrine', 'interventionNames': ['Drug: Phenylephrine', 'Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Norepinephrine Propofol Remifentanil', 'description': 'Prophylactic Norepinephrine', 'interventionNames': ['Drug: Norepinephrine', 'Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sodium chloride Propofol Remifentanil', 'description': 'NaCl Placebo', 'interventionNames': ['Drug: Sodium chloride', 'Drug: Propofol', 'Drug: Remifentanil']}], 'interventions': [{'name': 'Ephedrine', 'type': 'DRUG', 'otherNames': ['Ephedrine Sulphate Injection'], 'description': '0,1 mg/kg', 'armGroupLabels': ['Ephedrine Propofol Remifentanil']}, {'name': 'Phenylephrine', 'type': 'DRUG', 'otherNames': ['Phenylephrine Hydrocloride Injection'], 'description': '1 microg/kg', 'armGroupLabels': ['Phenylephrine Propofol Remifentanil']}, {'name': 'Norepinephrine', 'type': 'DRUG', 'otherNames': ['Noradrenalin'], 'description': '0,1 microg/kg', 'armGroupLabels': ['Norepinephrine Propofol Remifentanil']}, {'name': 'Sodium chloride', 'type': 'DRUG', 'otherNames': ['Sodium Chloride 0,9% injection'], 'description': '0,1 ml/kg', 'armGroupLabels': ['Sodium chloride Propofol Remifentanil']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Propolipid'], 'description': '2 mg/kg', 'armGroupLabels': ['Ephedrine Propofol Remifentanil', 'Norepinephrine Propofol Remifentanil', 'Phenylephrine Propofol Remifentanil', 'Sodium chloride Propofol Remifentanil']}, {'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': '1,7 microg/kg', 'armGroupLabels': ['Ephedrine Propofol Remifentanil', 'Norepinephrine Propofol Remifentanil', 'Phenylephrine Propofol Remifentanil', 'Sodium chloride Propofol Remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haugesund', 'country': 'Norway', 'facility': 'Helse Fonna, Haugesund Sykehus', 'geoPoint': {'lat': 59.41378, 'lon': 5.268}}], 'overallOfficials': [{'name': 'Gunnar Sjøen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helse Fonna'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'The data will be stored for 15 years after end of study, and may be shared during this time frame.', 'ipdSharing': 'YES', 'description': 'LiDCO-csv raw data and processed data will be made public at the publishers site, and the supporting information by request to the Principal Investigator. Statistical Data Plan is included in Study Protocol.', 'accessCriteria': 'The data may be shared by contacting the Principal Investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Fonna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant in Anesthesiology', 'investigatorFullName': 'Gunnar Helge Sjøen', 'investigatorAffiliation': 'Helse Fonna'}}}}