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.
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
- Conditions the study is for
- Intubation Complication, Cardiovascular Morbidity
- 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,
Show all 10Show fewer
- 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.
- Conditions
- Intubation Complication, Cardiovascular Morbidity
- 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 group | Role | What they receive |
|---|---|---|
| Magnesium Group | Active comparator | Magnesium Sulphate was administered through continuous infusion, immediately before induction of anesthesia Receives: Drug: Magnesium Sulphate |
| Lidocaine Group | Active comparator | Lidocaine 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.
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)
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
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
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.
- First posted10 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabricio Tavares Mendonca, Hospital de Base
- Investigators
- Fabricio T Mendonca, MD, TSA, Principal investigator, Hospital de Base do Distrito Federal, Brazil
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02359370
- Acronym / sponsor ID
- LidovsMgOTI
- Conditions
- Intubation Complication, Cardiovascular Morbidity
- Keywords
- Laryngoscopy, Tracheal Intubation, Lidocaine, Magnesium Sulphate, Cardiovascular Physiological Phenomena
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Group | Active comparator | Drug: Magnesium SulphateMagnesium Sulphate was administered through continuous infusion, immediately before induction of anesthesia |
| Lidocaine Group | Active comparator | Drug: LidocaineLidocaine was administered through continuous infusion, immediately before induction of anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineLidocaine 2 mg/kg was administered through continuous infusion, immediately before induction of anesthesia | Drug | Lidocaine Group |
| Magnesium SulphateMagnesium Sulphate 30 mg/kg was administered through continuous infusion, immediately before induction of anesthesia | Drug | Magnesium Group |
Primary outcome
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
3 secondary outcomes
Change in Diastolic Blood Pressure
Time frame: Within the first 6 minutes after oral intubation
Change in Heart Rate
Time frame: Within the first 6 minutes after oral intubation
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Within the first 6 minutes after oral intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Results publication: PubMed 25191450Nooraei 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.
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Recruiting
The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabricio T Mendonca, MD, TSA principal investigator
Hospital de Base do Distrito Federal, Brazil
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.