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Intubation ComplicationPhase 4NCT02359370

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

A Phase 4 study testing Lidocaine and Magnesium Sulphate in people with Intubation Complication and Cardiovascular Morbidity, run by Hospital de Base.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Lidocaine and Magnesium Sulphate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
No sites listed yet
Study dates
Sep 2014to Nov 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
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  • 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

About this study

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

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.

Read the 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.

Being tested
Lidocaine, Magnesium Sulphate
Keywords
Laryngoscopy, Tracheal Intubation, Lidocaine, Magnesium Sulphate, Cardiovascular Physiological Phenomena

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    Lidocaine 2 mg/kg was administered through continuous infusion, immediately before induction of anesthesia

  • Magnesium SulphateDrug

    Magnesium Sulphate 30 mg/kg was administered through continuous infusion, immediately before induction of anesthesia

Study groups in NCT02359370
Study groupRoleWhat they receive
Magnesium GroupActive comparatorMagnesium Sulphate was administered through continuous infusion, immediately before induction of anesthesia
Receives: Drug: Magnesium Sulphate
Lidocaine GroupActive comparatorLidocaine was administered through continuous infusion, immediately before induction of anesthesia
Receives: Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Systolic Blood Pressure Change in Systolic Blood Pressure

    Qualification of hemodynamic response to oral intubation by the change in SBP after Magnesium Sulfate or Lidocaine infusion

    Measured: Within the first 6 minutes after oral intubation

Secondary outcomes (3)
  1. Change in Diastolic Blood Pressure

    Qualification of hemodynamic response to oral intubation by the change in Diastolic Blood Pressure (DBP) after Magnesium Sulfate or Lidocaine infusion

    Measured: Within the first 6 minutes after oral intubation

  2. Change in Heart Rate

    Qualification of hemodynamic response to oral intubation by the change in HR after Magnesium Sulfate or Lidocaine infusion

    Measured: Within the first 6 minutes after oral intubation

  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Hemodynamic stability analysis during anesthesia induction through the incidence of tachycardia, hypertension, bradycardia, hypotension and consumed vasopressors

    Measured: Within the first 6 minutes after oral intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02359370
Sponsor's protocol ID
LidovsMgOTI
Status last verified
Feb 2015
First submitted
31 Jan 2015
Last updated
10 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Nooraei N, Dehkordi ME, Radpay B, Teimoorian H, Mohajerani SA. Effects of intravenous magnesium sulfate and lidocaine on hemodynamic variables following direct laryngoscopy and intubation in elective surgery patients. Tanaffos. 2013;12(1):57-63.

    PubMed 25191450

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine and Magnesium Sulphate in people with Intubation Complication and Cardiovascular Morbidity, run by Hospital de Base.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic Blood Pressure Change in Systolic Blood Pressure (time frame: Within the first 6 minutes after oral intubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02359370, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.

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