Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT03612492
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2018-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Lidocaine and Esmolol on Attenuation of Hemodynamic Response to Orotracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C036604', 'term': 'esmolol'}, {'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}], 'ancestors': [{'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'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': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-24', 'studyFirstSubmitDate': '2018-07-25', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with tachycardia after intubation', 'timeFrame': '12 minutes', 'description': 'Analysis of the incidence of tachycardia after intubation'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events as a measure of safety and tolerability', 'timeFrame': '12 minutes', 'description': 'Hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esmolol', 'lidocaine', 'intubation', 'hemodynamic response'], 'conditions': ['Hemodynamic Instability']}, 'referencesModule': {'references': [{'pmid': '25885726', 'type': 'BACKGROUND', 'citation': 'Singh S, Laing EF, Owiredu WK, Singh A. Comparison of esmolol and lidocaine for attenuation of cardiovascular stress response to laryngoscopy and endotracheal intubation in a Ghanaian population. Anesth Essays Res. 2013 Jan-Apr;7(1):83-8. doi: 10.4103/0259-1162.114008.'}, {'pmid': '28017170', 'type': 'BACKGROUND', 'citation': 'Mendonca FT, de Queiroz LM, Guimaraes CC, Xavier AC. Effects of lidocaine and magnesium sulfate in attenuating hemodynamic response to tracheal intubation: single-center, prospective, double-blind, randomized study. Braz J Anesthesiol. 2017 Jan-Feb;67(1):50-56. doi: 10.1016/j.bjane.2015.08.004. Epub 2016 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims to compare the hemodynamic response during laryngoscopy and orotracheal intubation using continuous infusion of lidocaine and esmolol in patients undergoing general anesthesia.', 'detailedDescription': 'Esmolol is a selective beta-blocker of fast action that antagonizes beta-1 adrenergic receptors. Venous lidocaine is the agent most used to attenuate the hemodynamic response to laryngoscopy and intubation, in addition to cough reflex.\n\nObjective: To compare the hemodynamic response during laryngoscopy and orotracheal intubation using continuous infusion of lidocaine and esmolol.\n\nMethods: Randomized, double masked clinical trial aims to compare the effect of esmolol and lidocaine on orotracheal intubation. All patients will receive balanced general anesthesia. One group (EG) will receive bolus esmolol of 1.5mg / kg in 10 min following by continuous infusion at a rate of 0.1mg / kg / min. The lidocaine (LG) group will receive lidocaine bolus of 1.5mg / kg in 10 min following by continuous infusion at a rate of 1.5mg / kg / h.\n\nData on hemodynamic changes, reaction to laryngoscopy, conditions at intubation and adverse events will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 70 years\n* Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)\n* Electively or urgently scheduled for surgery requiring general anesthesia, with programming of orotracheal intubation via direct laryngoscopy at the Base Hospital of the Federal District.\n\nExclusion Criteria:\n\n* Patients younger than 18 and over 70 years of age\n* Patients with contraindications or history of hypersensitivity to the drugs involved in the study\n* Patients with coronary ischemic disease\n* Patients with atrioventricular block at any grade\n* Patients with diagnosed cardiac arrhythmias\n* Patients with heart failure\n* Patients who are beta-blockers or calcium channel blockers\n* Patients with renal insufficiency of any kind\n* Patients with difficulty predicting orotracheal intubation\n* Patients with BMI ≥ 35 kg / m²\n* Patients who underwent neuroaxis block before anesthetic induction\n* Patients who refuse to participate in the study after submitting the informed consent form\n* Patients requiring two or more attempts of laryngoscopy for positioning of the orotracheal tube\n* Patients with asthma\n* Any other condition that, in the opinion of the researcher, may pose a risk to the patient or interfere with the objectives of the study'}, 'identificationModule': {'nctId': 'NCT03612492', 'briefTitle': 'The Effects of Lidocaine and Esmolol on Attenuation of Hemodynamic Response to Orotracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Base'}, 'officialTitle': 'The Effects of Lidocaine and Esmolol on Attenuation of Hemodynamic Response to Orotracheal Intubation: A Double-blind, Randomized, Clinical Trial', 'orgStudyIdInfo': {'id': 'Esmolol vs Lidocaine on OTI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Esmolol Group', 'description': 'Patients will receive esmolol during induction of anesthesia', 'interventionNames': ['Drug: Esmolol', 'Drug: Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine Group', 'description': 'Patients will receive lidocaine during induction of anesthesia', 'interventionNames': ['Drug: Esmolol', 'Drug: Lidocaine']}], 'interventions': [{'name': 'Esmolol', 'type': 'DRUG', 'otherNames': ['Beta blocker'], 'description': 'Esmolol group (EG) will receive a bolus of esmolol 1.5mg / kg in 10 min following by continuous infusion at a rate of 0.1mg / kg / min.', 'armGroupLabels': ['Esmolol Group', 'Lidocaine Group']}, {'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Local anesthetic'], 'description': 'Lidocaine (LG) group will received lidocaine bolus of 1.5mg / kg in 10 min following by continuous infusion at a rate of 1.5mg / kg / h.', 'armGroupLabels': ['Esmolol Group', 'Lidocaine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70680250', 'city': 'Brasília', 'state': 'Federal District', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Jamil Elias, MD', 'role': 'CONTACT', 'email': 'uamphbdf@gmail.com', 'phone': '556133151588'}, {'name': 'Viviane Rezende, MD', 'role': 'CONTACT', 'email': 'vrezende@icab.med.br', 'phone': '556133151331'}], 'facility': 'Hospital de Base do Distrito Federal', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Base', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Preceptor of Medical Residency in Anesthesiology', 'investigatorFullName': 'Fabricio Tavares Mendonca', 'investigatorAffiliation': 'Hospital de Base'}}}}