Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT07248202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia in Patients With Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'vasopressor dose', 'timeFrame': 'immediately after induction until 20 min after induction'}], 'primaryOutcomes': [{'measure': 'average postinduction NIRS', 'timeFrame': 'every 5 min after induction of anesthesia until 20 min after', 'description': 'average values of NIRS reading after induction of anesthesia'}], 'secondaryOutcomes': [{'measure': 'mean arterial pressure', 'timeFrame': 'every minute after induction of anesthesia until 20 min after induction', 'description': 'invasive mean arterial pressure'}, {'measure': 'heart rate', 'timeFrame': 'every minute after induction of anesthesia until 20 min after induction', 'description': 'bpm'}, {'measure': 'NRIS', 'timeFrame': 'during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min', 'description': 'average of left and right side reading'}, {'measure': 'cerebral hypoperfusion', 'timeFrame': 'during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min', 'description': 'NIRS\\<60% or \\<90% of baseline reading'}, {'measure': 'hypotension', 'timeFrame': 'immediately after induction of anesthesia until 20 min after induction', 'description': 'mean arterial pressure \\<70% of baseline or \\<65 mmHg'}, {'measure': 'extra fentanyl bolus', 'timeFrame': 'immediately after induction of anesthesia until 20 min after induction', 'description': 'mcg'}, {'measure': 'postoperative myocardial infarction', 'timeFrame': 'after extubation until 30 days postoperative', 'description': 'elevated troponin and new ECG changes'}, {'measure': 'postoperative stroke', 'timeFrame': 'after extubation until 30 days postoperative', 'description': 'new neurologic deficit'}, {'measure': 'postoperative acute kidney injury', 'timeFrame': 'after extubation until 30 days postoperative'}, {'measure': 'wound infection', 'timeFrame': 'after extubation until 30 days postoperative'}, {'measure': 'renal replacement therapy', 'timeFrame': 'after extubation until 30 days postoperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease (CAD)', 'Left Ventricular (LV) Systolic Dysfunction', 'Induction Anesthesia', 'Coronary Bypass Graft Surgery', 'Ketamine', 'Fentanyl', 'Lidocaine']}, 'descriptionModule': {'briefSummary': 'There is no consensus on the ideal induction technique for patients with coronary artery disease and left heart dysfunction. Induction for cardiac surgery focuses on maintaining hemodynamic stability, optimizing myocardial oxygen balance, and minimizing the intubation stress response. Ketamine provides stable hemodynamics in patients with impaired ventricular function, though combining it with opioids to blunt the intubation response may increase post-induction hypotension.\n\nSystemic lidocaine has anesthetic-sparing properties and has been shown to potentiate agents such as thiopentone, propofol, and midazolam. The ketamine-lidocaine combination has also demonstrated favorable hemodynamic effects in septic shock.\n\nThis study compares ketamine/fentanyl versus ketamine/lidocaine in term of their impact on cerebral perfusion during CABG. No prior data address these effects, and the goal is to identify the induction regimen that better preserves cerebral oxygenation.', 'detailedDescription': "Upon arrival to the operating room, initial monitoring will include five lead electrocardiograms, non-invasive blood pressure, and pulse oximetry. At the attending anesthetist's discretion, intravenous midazolam will be administered for anxiolytics. Under local anesthesia, an arterial line will be placed in the radial artery of the non-dominant hand and central venous line will be placed in the right internal jugular vein.\n\nCerebral oximetry monitoring using Near-Infrared Spectroscopy (NIRS) bilaterally (CASMED, Module series Fore-sight Elite, \\[SN\\]1931030) will be applied to all patients. After cleansing of the adjacent skin area with alcohol, an adhesive optode pad was placed over each fronto-temporal area. Resting baseline rSO2 values will be obtained after waiting at least 1 min after placement of sensors once values had stabilized. Bispectral index (BIS) will be applied.\n\nThe baseline data for the heart rate, systolic, diastolic, and mean systemic arterial pressures will be recorded from the average ward measurement the day before surgery.\n\nin all patients, ketamine will be injected slowly at 1.5 mg/kg in 0.25 mg/kg increments until clinical loss of consciousness. Clinical loss of consciousness (defined as no response to auditory command) will be assessed by asking the patients repeatedly to open their eyes. After loss of consciousness, atracurium 0.5 mg/kg will be administered to facilitate tracheal intubation. Tachycardia and hypertension, (20% increase heart rate, blood pressure from baseline reading) will be managed by a 50 mcg-bolus of Fentanyl. Anesthesia will be maintained by isoflurane (adjusted to maintain end-tidal minimal alveolar concentration of 1-1.2 %) in oxygen/air mixture. Mechanical ventilation will be adjusted to maintain end-tidal CO2 of 35-40 mmHg Any episode of hypotension (defined as mean arterial pressure \\[MAP\\] \\< 70% of the baseline reading and/or MAP \\<65mmHg, will be managed by 5 mcg norepinephrine (which could be repeated if hypotension persists for 1-min, NE infusion will be started if persisted after 3 boluses). Ephedrine bolus will be give if hypotension was associated with bradycardia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with coronary artery disease\n* with moderate to severe left ventricular dysfunction (ejection fraction \\< 40%),\n* scheduled for elective CABG surgery\n\nExclusion Criteria:\n\n* associated chronic stroke, TIA , carotid occlusive disease( due to abnormal vasomotor activity), patients with known neurological impairment (cerebral infarction , dementia ), significant carotid artery stenosis ,\n* valvular heart disease,\n* persistent arrhythmias,\n* congestive cardiac failure,\n* on mechanical ventilation,\n* intra-aortic balloon pump,\n* emergency surgery,\n* and those with known allergy to any of the study's drugs,\n* severe systemic non-cardiac disease and\n* patients with baseline NIRS reading \\< 60%\n* Patients with dementia or visual or auditory impairment"}, 'identificationModule': {'nctId': 'NCT07248202', 'briefTitle': 'Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia in Patients With Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'A Comparison Between the Effect of Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia on Cerebral Perfusion Guided by Near Infra-red Spectroscopy in Patients With Coronary Artery Disease and Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery Bypass Graft Surgery: (A Randomized Controlled Study)', 'orgStudyIdInfo': {'id': 'MD-396-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fentanyl group', 'description': 'fentanyl bolus during induction of anesthesia', 'interventionNames': ['Drug: Fentanyl (IV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine group', 'description': 'lidocaine bolus during the induction of anesthesia', 'interventionNames': ['Drug: lidocaine']}], 'interventions': [{'name': 'Fentanyl (IV)', 'type': 'DRUG', 'description': 'patients will receive 1 mcg/kg of Fentanyl (10 mcg/mL).', 'armGroupLabels': ['fentanyl group']}, {'name': 'lidocaine', 'type': 'DRUG', 'description': 'patients will receive 1 mg/kg lidocaine (10mg/mL)', 'armGroupLabels': ['lidocaine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Maha Mostafa', 'role': 'CONTACT', 'email': 'maha.mostafa@cu.edu.eg', 'phone': '+201000365115'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data related to this research are available form the PI upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ahmed Hasanin', 'investigatorAffiliation': 'Cairo University'}}}}