Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT06772727
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2025-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'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'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-19', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypotension', 'timeFrame': 'immediately after induction of anesthesia until 20 minutes after induction of anesthesia', 'description': 'Incidence of post-induction hypotension'}], 'secondaryOutcomes': [{'measure': 'Norepinephrine dose', 'timeFrame': 'from induction of anesthesia until 20 minutes after skin incision', 'description': 'Total norepinephrine dose during the period from induction of anesthesia until 20-minutes after intubation or skin incision'}, {'measure': 'Heart rate', 'timeFrame': 'every 2 minutes for 20 minutes after induction of anesthesia'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'every 2 minutes for 20 minutes after induction of anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-induction Hypotension', 'Lidocaine', 'Opioid', 'Emergency Laparotomy']}, 'descriptionModule': {'briefSummary': 'The primary role of anesthesia is to provide unconsciousness, amnesia, immobility, and pain control. Other important roles include maintaining stable vital signs and tissue perfusion, preventing and management of organ failure.\n\nEmergency laparotomy represents a major surgical procedure which is usually performed in patients with acute and chronic comorbidities and is associated with several surgical and medical complications with post-induction hypotension being one of the common and serious complication. Thus, it is essential to provide a balanced and safe protocol for anesthesia which maintains adequate hypnosis and antinociception besides vital stability and adequate perfusion.\n\nOpioid drugs are commonly used within the context of balanced general anesthesia primarily for their antinociceptive effects. Opioid drugs had been a basic component of perioperative care for providing analgesia and decreasing the requirements of other hypnotic drugs. However, there are several short- and long-term adverse effects for opioid drugs such as pruritus, postoperative nausea and vomiting, respiratory depression, dependence, and development of chronic pain. Furthermore, opioid drugs are claimed to have cardiovascular depressant effects which increases the risk of hypotension if they were used routinely in patients with borderline hemodynamic profile. Therefore, there is an increased interest in opioid-sparing and opioid-free anesthesia and several international consensus statements were released to regulate and suggest protocols for opioid-sparing anesthetic regimens.\n\nLidocaine-based anesthesia had been recently reported as a successful regimen for induction of anesthesia in elderly population with better hemodynamic profile than opioid-based induction. The investigators hypothesize that lidocaine-based induction of anesthesia would provide superior hemodynamic profile compared to conventional opioid-based induction of anesthesia in emergency laparotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients\n2. Both gender\n3. American Society of Anesthesiologists (ASA) class I-III undergoing emergency laparotomy.\n\nExclusion Criteria:\n\n1. Patient refusal\n2. Severe cardiac morbidities (impaired contractility with ejection fraction \\< 45%, heart block, arrhythmias, tight valvular lesions)\n3. Baseline mean arterial pressure \\<75 mmHg\n4. Patients on vasopressor infusion,\n5. Patients with high shock index (heart rate / systolic blood pressure \\>1)\n6. Pregnant or lactating women,\n7. Allergy of any of the study drugs\n8. Hypertensive patients and patients on beta blockers.\n9. Uncontrolled hypertensive patients or patients receiving angiotensin converting enzyme (ACE) inhibitors preoperatively.\n10. Opioid drug abusers.\n11. Patients with increased intracranial tension.'}, 'identificationModule': {'nctId': 'NCT06772727', 'briefTitle': 'Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparison of Hemodynamic Effect of Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'MD-265-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine group', 'description': 'Patients will receive 1 mg/kg lidocaine intravenously (IV)', 'interventionNames': ['Drug: Lidocaine', 'Drug: Propofol', 'Drug: Succinyl choline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl group', 'description': 'Patients will receive 1 mcg/kg fentanyl intravenously (IV)', 'interventionNames': ['Drug: Fentanyl', 'Drug: Propofol', 'Drug: Succinyl choline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'After preoxygenation with 100% oxygen for 3 minutes, the study drug (lidocaine) will be administered. Patients will receive 1 mg/kg lidocaine of 10 mg/mL lidocaine solution (prepared by diluting 5 mL of lidocaine 20% in saline to a total volume of 10 mL)', 'armGroupLabels': ['Lidocaine group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'After preoxygenation with 100% oxygen for 3 minutes, the study drug (fentanyl) will be administered. Patients will receive 1 mcg/kg fentanyl of 10 mcg/mL fentanyl solution (prepared by diluting 100 mcg fentanyl in saline to a total volume of 10 mL).', 'armGroupLabels': ['Fentanyl group']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'After administration of the study drug, all patients will receive 2 mg/kg propofol intravenously', 'armGroupLabels': ['Fentanyl group', 'Lidocaine group']}, {'name': 'Succinyl choline', 'type': 'DRUG', 'description': 'After loss of consciousness, 1 mg/kg succinyl choline will be administered over 5 seconds, and tracheal intubation will be done through direct laryngoscopy after 60 seconds.', 'armGroupLabels': ['Fentanyl group', 'Lidocaine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Kareem MA Nawwar, M.D.', 'role': 'CONTACT', 'email': 'drknawwar@cu.edu.eg', 'phone': '+201003878369'}], 'facility': 'Faculty of Medicine, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Kareem MA Nawwar, M.D.', 'role': 'CONTACT', 'email': 'drknawwar@cu.edu.eg', 'phone': '+201003878369'}], 'overallOfficials': [{'name': 'Jehan Elkholy, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Eman F Ali,, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Kareem MA Nawwar, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Mohsen M Waheeb, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Samar M Abdel Azeim Ghazala, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Kareem Mohammed Assem Nawwar', 'investigatorAffiliation': 'Cairo University'}}}}