Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT06226532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2024-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Lidocaine Sprayed for Attenuating Hemodynamic Response During Laryngoscopy and Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Group SL: 10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff.\n2. Group IL: 2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changing in mean arterial pressure (MAP) during the peri-intubation period', 'timeFrame': 'T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation', 'description': 'Mean arterial pressure was recorded in mmHg by the anesthesiologist'}, {'measure': 'Changing in blood pressure (BP) during the peri-intubation period', 'timeFrame': 'T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation', 'description': 'Blood pressure was recorded in mmHg by the anesthesiologist'}, {'measure': 'Changing in heart rate (HR) during the peri-intubation period', 'timeFrame': 'T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation', 'description': 'Heart rate was recorded in bpm by the anesthesiologist'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse event during laryngoscopy and intubation procedure', 'timeFrame': 'During laryngoscopy and intubation procedure', 'description': 'Adverse events were recorded by the anesthesiologist. The adverse events included coughing, desaturation, aspiration, hypotension, hypertension, tachycardia, and bradycardia'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lidocaine', 'Laryngoscopy and intubation', 'Hemodynamics', 'Neurosurgery'], 'conditions': ['Laryngoscopy', 'Intubation', 'Hemodynamics', 'Neurosurgery', 'Lidocaine']}, 'referencesModule': {'references': [{'pmid': '21455075', 'type': 'BACKGROUND', 'citation': 'Ismail SA, Bisher NA, Kandil HW, Mowafi HA, Atawia HA. Intraocular pressure and haemodynamic responses to insertion of the i-gel, laryngeal mask airway or endotracheal tube. Eur J Anaesthesiol. 2011 Jun;28(6):443-8. doi: 10.1097/EJA.0b013e328345a413.'}, {'pmid': '10861145', 'type': 'BACKGROUND', 'citation': 'Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.'}, {'pmid': '24370755', 'type': 'BACKGROUND', 'citation': 'Tada Y, Wada K, Shimada K, Makino H, Liang EI, Murakami S, Kudo M, Kitazato KT, Nagahiro S, Hashimoto T. Roles of hypertension in the rupture of intracranial aneurysms. Stroke. 2014 Feb;45(2):579-86. doi: 10.1161/STROKEAHA.113.003072. Epub 2013 Dec 26.'}, {'pmid': '23824697', 'type': 'BACKGROUND', 'citation': 'Khan FA, Ullah H. Pharmacological agents for preventing morbidity associated with the haemodynamic response to tracheal intubation. Cochrane Database Syst Rev. 2013 Jul 3;2013(7):CD004087. doi: 10.1002/14651858.CD004087.pub2.'}, {'pmid': '19947809', 'type': 'BACKGROUND', 'citation': 'Gerlach AT, Murphy CV. Dexmedetomidine-associated bradycardia progressing to pulseless electrical activity: case report and review of the literature. Pharmacotherapy. 2009 Dec;29(12):1492. doi: 10.1592/phco.29.12.1492.'}, {'pmid': '3631567', 'type': 'BACKGROUND', 'citation': 'Tam S, Chung F, Campbell M. Intravenous lidocaine: optimal time of injection before tracheal intubation. Anesth Analg. 1987 Oct;66(10):1036-8. No abstract available.'}, {'pmid': '3828177', 'type': 'BACKGROUND', 'citation': 'Shribman AJ, Smith G, Achola KJ. Cardiovascular and catecholamine responses to laryngoscopy with and without tracheal intubation. Br J Anaesth. 1987 Mar;59(3):295-9. doi: 10.1093/bja/59.3.295.'}, {'pmid': '24619576', 'type': 'BACKGROUND', 'citation': 'Lee SY, Min JJ, Kim HJ, Hong DM, Kim HJ, Park HP. Hemodynamic effects of topical lidocaine on the laryngoscope blade and trachea during endotracheal intubation: a prospective, double-blind, randomized study. J Anesth. 2014 Oct;28(5):668-75. doi: 10.1007/s00540-014-1812-z. Epub 2014 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to to evaluate the efficacy of lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff compare with intravenous lidocaine on the hemodynamic response to laryngoscopy and intubation in patients undergoing elective neurological procedures during general anesthesia with total intravenous technique.\n\nThe main question it aims to answer is:\n\n\\- Does topical lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff have more effect on stabilizing hemodynamic responses to laryngoscopy and intubation than intravenous lidocaine, in neurosurgical patients who undergo general anesthesia with total intravenous technique?\n\nParticipants will be recruited and randomized to receive either lidocaine spray (Group SL) or intravenous lidocaine (group IL) to blunt hemodynamic response to laryngoscopy and intubation.', 'detailedDescription': "Anesthetic protocol\n\n* Preoperative\n\n * After the informed consent, all eligible patients will be fasting after midnight as it is an elective procedure.\n * No preoperative sedatives or analgesics were administered.\n* Intraoperative Pre-induction phase\n\n * Standard monitors of electrocardiogram, noninvasive blood pressure (NIBP) is measured at upper extremity with BP cuff bladder length ≥ 80% and width ≥40% of patient's arm circumference and pulse oximeter were attached.\n * BIS (Bispectral index) was monitored\n * Hemodynamic baseline values of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded before the induction.\n\nIntervention: prepared before induction anesthesia.\n\n* Group SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg).\n* Group IL: 2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).\n\nInduction phase\n\n* Preoxygenation 100% oxygen, flow 6 liters per minute, for 3-5 minutes, target end tidal oxygen more than 90%\n* Medication before the induction of anesthesia includes fentanyl 1.5 mcg/kg IV.\n* General anesthesia will be induced with propofol target-controlled infusion (TCI) 4-6 mcg/ml IV, followed by cisatracurium 0.15 mg/kg IV for intubation.\n* Bag mask ventilation will be started.\n* The arterial line will be canulated before direct laryngoscopy and intubation and arterial line pressure transducer will be levelled at the phlebostatic axis and calibrate with NIBP.\n* Intervention: Group IL: 2% lidocaine 1.5 mg/kg IV was given 2 minutes after cisatracurium injection.\n* Direct laryngoscopy and tracheal intubation were done by an anesthesiologist, 1st (6 months experience), 2nd, and 3rd years anesthesiology resident.\n\nAt 5 minutes after cisatracurium injection, direct laryngoscopy will be performed, and spray 10%lidocaine directly to the epiglottis for 4 puffs for SL group.\n\n* Tracheal intubation will be performed.\n* The bispectral index (BIS) target range during intubation is 40 to 60.\n* The hemodynamic parameters including mean arterial pressure(MAP) in mmHg, systolic blood pressure(SBP) in mmHg, diastolic blood pressure(DBP) in mmHg and heart rate(HR) in beats per minutes(bpm) and BIS will record during the peri-intubation period\n\nAll the adverse events (cough, pulmonary aspiration, desaturation, hypotension, hypertension, tachycardia, bradycardia, and arrythmia) will be noted as yes or no."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-65 years old\n2. American Society of Anesthesiologists (ASA) physical status classification I-II\n\nExclusion Criteria:\n\n1. History of lidocaine allergy\n2. Predicted difficult airways\n3. Body mass index \\> 35 kilograms per meter squared\n4. Risk aspiration\n5. Baseline hemodynamic instability; heart rate \\< 50 bpm, heart rate \\> 120 bpm, blood pressure \\< 90/60 mmHg, blood pressure \\> 160/90 mmHg\n6. Underlying disease: epilepsy, cardiovascular disease, heart failure, impaired cardiac function, severe renal dysfunction, impaired hepatic function, peripheral vascular disease\n7. Pregnancy\n8. Cerebral aneurysm, Arteriovenous malformation, Tumor size \\> 4 centimeters, Brain herniation'}, 'identificationModule': {'nctId': 'NCT06226532', 'briefTitle': 'Effect of Lidocaine Sprayed for Attenuating Hemodynamic Response During Laryngoscopy and Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Effect of Lidocaine Sprayed at the Laryngeal Inlet and Endotracheal Tube Cuff Versus Intravenous Lidocaine for Attenuating Hemodynamic Response During Laryngoscopy and Intubation in Neurosurgical Patients', 'orgStudyIdInfo': {'id': 'HE661362'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group SL', 'description': '10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff, 4 puffs each.', 'interventionNames': ['Drug: lidocaine spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group IL', 'description': '2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.', 'interventionNames': ['Drug: Intravenous Lidocaine']}], 'interventions': [{'name': 'lidocaine spray', 'type': 'DRUG', 'otherNames': ['10% lidocaine spray'], 'description': 'Group SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg)', 'armGroupLabels': ['Group SL']}, {'name': 'Intravenous Lidocaine', 'type': 'DRUG', 'otherNames': ['2%Intravenous Lidocaine'], 'description': '2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).', 'armGroupLabels': ['Group IL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Nai Muang', 'state': 'KhonKaen', 'country': 'Thailand', 'contacts': [{'name': 'Nattawadee Phokaw, M.D.', 'role': 'CONTACT', 'email': 'nattapho@kku.ac.th', 'phone': '0619719493'}, {'name': 'Nattawadee Phokaw, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Cattleya Kasemsiri, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Narin Plailahan, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Apinya Kittiponghansa, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pornthep Kasemsiri, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thirada Jimarsa, B.N.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wayuda Paksiri, B.N.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Darunee Sripadungkul, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Khon Kaen University', 'geoPoint': {'lat': 15.17901, 'lon': 100.1282}}], 'centralContacts': [{'name': 'Nattawadee Phokaw, MD', 'role': 'CONTACT', 'email': 'Nattapho@kku.ac.th', 'phone': '+66619719493'}], 'overallOfficials': [{'name': 'Nattawadee Phokaw, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of anesthesiologist, Faculty of Medicine, Khon Kaen University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'All collected individual participant data (IPD)', 'accessCriteria': 'Researcher who required more information for further study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nattawadee Phokaw, MD', 'investigatorAffiliation': 'Khon Kaen University'}}}}