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The Effects of Lidocaine and Magnesium Sulphate on the Attenuation of the Hemodynamic Response to Tracheal Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02359370
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Fabricio Tavares Mendonca, Hospital de Base

Brief Summary:
Justification and Objectives: The hemodynamic response to stimuli of the airways is a common phenomenon and its control is important to decrease systemic repercussions. The objective of this study is to compare the effects of intravenous administration of Magnesium Sulphate versus Lidocaine in the hemodynamics of this reflex after laryngoscopy and tracheal intubation. Methods: This double blind, randomized, single center, and prospective study evaluated 56 patients, ASA 1 or 2, aged between 18 and 65 years, scheduled for elective surgeries under general anesthesia with tracheal intubation. Patients were divided into two groups. Group M received 30mg/kg of Magnesium Sulphate, and group L 2 mg/kg of Lidocaine through continuous infusion, immediately before induction of anesthesia. The values for blood pressure (BP), heart rate (HR) and bispectral index (BIS) were measured in both groups at six distinct moments related to the administration of the drugs under study.

Condition or disease Intervention/treatment Phase
Intubation Complication Cardiovascular Morbidity Drug: Lidocaine Drug: Magnesium Sulphate Phase 4

Detailed Description:

This double-blind, randomized, single center, prospective study was approved by the Local Research Ethics Committee (FEPECS/SES-DF) under the report number 799.112 and has been identified on the Plataforma Brasil (http://aplicacao.saude.gov.br/plataformabrasil) under CAAE (Certificate of Presentation for Ethical Consideration) number 33365114.7.0000.5553. After written informed consent, 56 patients, ASA P1 or P2, aged between 18 and 65 years, scheduled for elective surgeries with orotracheal intubation (OTI), were assessed regarding their eligibility between the months of September and November, 2014 Of the 56 patients selected for the study according to the inclusion criteria, 7 were excluded during the evaluations, four from group M because of: frequent ventricular extrasystoles, introduction of nasal swab of adrenaline before the end of evaluations, intubation with video-laryngoscope and lack of sevoflurane in the vaporizer not checked during the evaluations. Three more patients were excluded from group L: one because of leakage of drugs (poorly secured venous access), another because of vomiting with consequent aspiration during ventilation with mask, and another for failed intubation in the first laryngoscopy.

When arriving in the surgery room, the patient was first identified, followed by standard monitoring with cardioscope (ECG), peripheral oxygen saturation (SpO2), noninvasive blood pressure (NIBP) and bispectral index (BIS). Venoclysis was performed at the discretion of the anesthesiologist, in accordance with the scale of the surgery/anesthesia ("Admission" time). Next, the pre-anesthetic medication was administered with midazolam (MDZ) in the dose of 0.05mg/kg. After two minutes (Time "2' after-MDZ"), the infusion with the drug under study was started, with a dose of 2mg/kg for lidocaine or 30mg/kg for magnesium sulphate, both diluted in 15mL of solution and infused in 10 minutes through a continuous infusion pump (CIP). After finishing the infusion (Time "End-CIP"), pre-oxygenation and anesthetic induction with intravenous fentanyl 2mcg/kg was performed, followed by propofol 2 mg/kg and rocuronium 0.6 mg/kg (Time "after-Ind"). The laryngoscopy was performed three minutes after the end of the rocuronium injection and if the BIS value was equal to or less than 50 (Time "after-OTI"). If the BIS value was not reached, a venous increment of 1mg/kg of propofol was administered. After orotracheal intubation, anesthesia was maintained through inhalation with sevoflurane 2%, and new measurements were taken after 3 and 6 minutes of intubation (Times "3' after-OTI" and "6' after-OTI"). Hypertension was considered when the BP values were 20% above baseline values or if Systolic Blood Pressure (SBP) > 140 mmHg. Hypotension was considered when the Blood Pressure (BP) values were 20% below baseline values or if SBP > 90 mmHg. Tachycardia was considered when the Heart Rate (HR) values were 20% above baseline values or if HR > 100 mmHg. Bradycardia was considered for HR values under 50 bpm.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Effects of Lidocaine and Magnesium Sulphate on the Attenuation of the Hemodynamic Response to Tracheal Intubation: Single Center, Prospective, Double-Blind and Randomized Study
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Magnesium Group
Magnesium Sulphate was administered through continuous infusion, immediately before induction of anesthesia
Drug: Magnesium Sulphate
Magnesium Sulphate 30 mg/kg was administered through continuous infusion, immediately before induction of anesthesia

Active Comparator: Lidocaine Group
Lidocaine was administered through continuous infusion, immediately before induction of anesthesia
Drug: Lidocaine
Lidocaine 2 mg/kg was administered through continuous infusion, immediately before induction of anesthesia




Primary Outcome Measures :
  1. Change in Systolic Blood Pressure Change in Systolic Blood Pressure [ Time Frame: Within the first 6 minutes after oral intubation ]
    Qualification of hemodynamic response to oral intubation by the change in SBP after Magnesium Sulfate or Lidocaine infusion


Secondary Outcome Measures :
  1. Change in Diastolic Blood Pressure [ Time Frame: Within the first 6 minutes after oral intubation ]
    Qualification of hemodynamic response to oral intubation by the change in Diastolic Blood Pressure (DBP) after Magnesium Sulfate or Lidocaine infusion

  2. Change in Heart Rate [ Time Frame: Within the first 6 minutes after oral intubation ]
    Qualification of hemodynamic response to oral intubation by the change in HR after Magnesium Sulfate or Lidocaine infusion

  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Within the first 6 minutes after oral intubation ]
    Hemodynamic stability analysis during anesthesia induction through the incidence of tachycardia, hypertension, bradycardia, hypotension and consumed vasopressors



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA 1 or 2, aged between 18 and 65 years, scheduled for elective surgeries with orotracheal intubation at the Hospital de Base do Distrito Federal, Brazil

Exclusion Criteria:

  • Patients who have contraindication or a history of hypersensitivity to the drugs involved in the work
  • Patients with ischemic heart disease, atrioventricular block in any degree, diagnosed cardiac arrhythmias, heart failure
  • Renal failure carrier
  • Users of beta-blockers or calcium channel blockers,
  • Patients who have forecast of difficult tracheal intubation,
  • BMI < 35 kg/m2,
  • Patients in whom neuroaxis block was performed before the induction of anesthesia,
  • Patients who refused to participate in the study
  • Those who needed two or more laryngoscopy attempts to position the orotracheal tube,
  • Any other condition that, in the researchers' opinion, could offer risks to the patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359370


Sponsors and Collaborators
Hospital de Base
Investigators
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Principal Investigator: Fabricio T Mendonca, MD, TSA Hospital de Base do Distrito Federal, Brazil
Publications of Results:
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Responsible Party: Fabricio Tavares Mendonca, MD, TSA, Hospital de Base
ClinicalTrials.gov Identifier: NCT02359370    
Other Study ID Numbers: LidovsMgOTI
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Keywords provided by Fabricio Tavares Mendonca, Hospital de Base:
Laryngoscopy
Tracheal Intubation
Lidocaine
Magnesium Sulphate
Cardiovascular Physiological Phenomena
Additional relevant MeSH terms:
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Lidocaine
Magnesium Sulfate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anticonvulsants
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents