Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT03640468
Status:
UNKNOWN
Last Update Posted:
2018-11-21
First Post:
2018-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-20', 'studyFirstSubmitDate': '2018-08-18', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean arterial pressure', 'timeFrame': '10 minutes after induction of general anesthesia', 'description': 'Mean arterial pressure measured in mmHg'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '10 minutes after induction of general anesthesia', 'description': 'number of heart beats per minutes'}, {'measure': 'Cardiac output', 'timeFrame': '10 minutes after induction of general anesthesia', 'description': 'volume of blood pumped by the heart in one minute measured in liters per minute'}, {'measure': 'The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia', 'timeFrame': '10 minutes after induction of general anesthesia'}, {'measure': 'Norepinephrine consumption', 'timeFrame': '10 minutes after induction of general anesthesia', 'description': 'The total dose of norepinephrine measured in micrograms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septic Shock', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'The aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.', 'detailedDescription': 'Most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. Thus, induction of anesthesia in shocked patients might result in deleterious hypotension. Patients with severe sepsis and septic shock frequently need surgical interventions. The best protocol for induction of anesthesia in septic shock patients is lacking.\n\nKetamine is an agent used for induction of anesthesia with known positive cardiovascular effects. However, these positive effects were reported in individuals with intact sympathetic nervous system. Invitro studies showed that ketamine direct action on the cardiac muscles is negative. Thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present.\n\nLidocaine is a drug with multiple local and systemic uses. Having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. Lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged above 18 years\n* With septic shock\n* Scheduled for general anesthesia\n\nExclusion Criteria:\n\n* Patients under 18 years\n* Burn patients'}, 'identificationModule': {'nctId': 'NCT03640468', 'briefTitle': 'Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'N-128-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine group', 'description': 'This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.', 'interventionNames': ['Drug: Ketamine full dose', 'Drug: Midazolam', 'Drug: Normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine-ketamine group', 'description': 'This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.', 'interventionNames': ['Drug: Ketamine half dose', 'Drug: Lidocaine', 'Drug: Midazolam']}], 'interventions': [{'name': 'Ketamine full dose', 'type': 'DRUG', 'otherNames': ['Ketamine hydrochloride'], 'description': 'This group will receive induction of anesthesia using Ketamine 1 mg/Kg', 'armGroupLabels': ['Ketamine group']}, {'name': 'Ketamine half dose', 'type': 'DRUG', 'otherNames': ['Ketamine Hydrochloride'], 'description': 'This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg', 'armGroupLabels': ['Lidocaine-ketamine group']}, {'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Lidocaine Hydrochloride'], 'description': 'This group will receive lidocaince 1 mg/Kg', 'armGroupLabels': ['Lidocaine-ketamine group']}, {'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Dormicum'], 'description': 'This group will receive midazolam 0.05 mg/Kg', 'armGroupLabels': ['Ketamine group', 'Lidocaine-ketamine group']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'This group will receive normal saline 10 mL', 'armGroupLabels': ['Ketamine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sarah Amin, Lecturer', 'role': 'CONTACT', 'email': 'sarahamin_22@hotmail.com', 'phone': '+201227476617'}], 'overallOfficials': [{'name': 'Ahmed Hasanin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor of anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of anesthesia and critical care', 'investigatorFullName': 'Ahmed Hasanin', 'investigatorAffiliation': 'Cairo University'}}}}