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

NCT02359370 | Completed Phase 4

• 1 other identifier: LidovsMgOTI
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intubation Complication; Cardiovascular Morbidity

Keywords

Laryngoscopy; Tracheal Intubation; Lidocaine; Magnesium Sulphate; Cardiovascular Physiological Phenomena

Outcome Measures

Primary Outcomes (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

  Within the first 6 minutes after oral intubation

Secondary Outcomes (3)

• Change in Diastolic Blood Pressure

  Within the first 6 minutes after oral intubation

• Change in Heart Rate

  Within the first 6 minutes after oral intubation

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

  Within the first 6 minutes after oral intubation

Study Arms (2)

Magnesium Group

ACTIVE COMPARATOR

Magnesium Sulphate was administered through continuous infusion, immediately before induction of anesthesia

Drug: Magnesium Sulphate

Lidocaine Group

ACTIVE COMPARATOR

Lidocaine was administered through continuous infusion, immediately before induction of anesthesia

Drug: Lidocaine

Interventions

Lidocaine DRUG

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

Lidocaine Group

Magnesium Sulphate DRUG

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

Magnesium Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Base: lead

Related Publications (1)

• 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.

  PMID: 25191450 RESULT

MeSH Terms

Interventions

Lidocaine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Fabricio T Mendonca, MD, TSA

  Hospital de Base do Distrito Federal, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, TSA

Study Record Dates

• First Submitted: January 31, 2015
• First Posted: February 10, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 10, 2015

Record last verified: 2015-02