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Study Protocol

Evaluation of intravenous magnesium sulphate on haemodynamic responses to laryngoscopy and tracheal intubation in surgeries of ear, nose and throat

[version 1; peer review: 2 approved with reservations]
PUBLISHED 07 May 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Heart rate, arterial blood pressure, and arrhythmias significantly surge during laryngoscopy and intubation. Anesthesiologists constantly look for ways to minimize these unwanted reactions. Several medicinal interventions have been suggested to mitigate these side effects; intravenous magnesium sulphate injection is one such intervention. Magnesium sulphate is a divalent salt widely recognized for its capacity to lower sympathetic nervous system muscle cell excitability, which lowers blood pressure and causes vasodilation. It is approved as a medicine to treat preeclampsia and control blood pressure. Moreover, there is growing recognition of its benefits on hemodynamic parameters in patients suffering from ischemic infective endocarditis and heart disease. Magnesium is an asset for reducing negative cardiovascular reactions occurring at the time of laryngoscopy and intubation because of its capacity to reduce catecholamine synthesis from adrenergic nerve ends and the adrenal medulla. Intravenous magnesium sulphate will be used in this trial to assess its effect on reducing adverse hemodynamic responses in candidates for elective laryngoscopy and intubation for ENT surgeries.

Keywords

Haemodynamic response, Magnesium sulphate, Endotracheal intubation, laryngoscopy

Introduction

Due to the stimulation of the sympathetic-adrenal system, airway manipulation techniques such as laryngoscopy and orotracheal intubation cause a reflexive sympathetic reaction. This reaction may affect the neurohumoral and cardiovascular systems in various manners. The consequences include vasoconstriction, an increase in cardiac workload, a rise in the demand for coronary blood flow, and constricted coronary arteries that are incapable of withstanding this greater flow. As a result, the myocardium may not get enough oxygen in certain areas. Elevated blood pressure, rapid heart rate, and high levels of adrenaline and norepinephrine are the most prominent outcomes of this response.14 This response is usually transient, but elderly individuals and those with specific medical conditions—diabetes, heart failure, systemic arterial hypertension, coronary artery disease, cardiac arrhythmias, cerebrovascular disease, and pulmonary disorders—may be more susceptible to arrhythmias, myocardial ischemia or infarction, and cerebral haemorrhage.5

Many strategies are being used to mitigate the hemodynamic reactions secondary to laryngoscopy and intubation. Utilizing various pharmacological techniques, such as topical anesthesia, narcotics, adrenoreceptor blockers, calcium channel blockers, sodium channel blockers, vasodilators like nitroglycerin, intravenous magnesium sulphate, and paracetamol, as well as ensuring deep anesthesia is among them.6

Recently, it has been shown that magnesium sulphate, a medication used to prevent seizures in eclamptic patients, may also decrease the stress reactions brought on by tracheal intubation and laryngoscopy when given in small quantities.79 Inhibiting the adrenal glands’ secretion of catecholamines, magnesium sulphate (MgSO4) lowers the amount of adrenaline in the blood. Consequently, bradycardia, vasodilation, and atrial contractions are reduced.1012 Therefore, in cases where other medications might not be appropriate, magnesium sulphate can be considered an alternative to other medicines for reducing the pressor response caused by laryngoscopy and tracheal intubation.

Aim

To evaluate the impact of intravenous magnesium sulphate on hemodynamic responses during tracheal intubation and laryngoscopy.

Objectives

  • Primary objective: To assess magnesium sulfate’s influence on cardiovascular responses by evaluating vital signs, heart rate, and cardiac workload during laryngoscopy and orotracheal intubation.

  • Secondary objective

    • To identify patient groups that may benefit from MgSO4 as a stress response attenuator, including elderly people or those with diabetes, coronary artery disease, and hypertension.

    • To monitor and contrast any adverse reactions that could arise following the administration of magnesium sulphate.

Methods

Study design – A prospective, randomized, double-blind clinical trial.

Study period – Two years.

Study setting – Department of Anaesthesiology in AVBRH and JNMC, Sawangi, Wardha.

Allocation of patients – Patients will be allotted to the study groups by computer-generated randomization.

Study population – The study will be conducted on patients undergoing elective ENT surgeries, fulfilling the following.

Inclusion criteria

  • Patients who provide a valid written and informed consent after understanding the study methodology.

  • Patients (20 to 60 years of age) weighing between 40 and 65 kgs of either gender.

  • Physical status I and II of the ASA.

  • Individuals posted for elective ENT surgery.

Exclusion criteria

  • Patients denying to provide written and informed consent,

  • Patients posted for emergency surgery,

  • Patients with neurological, pulmonary, renal, hepatic, endocrine, or cardiovascular disease,

  • Patients with sinus bradycardia, heart blocks, conduction abnormalities, and those on digitalis, calcium channel blockers, α and β-agonists or antagonists,

  • Patients with a BMI above 35,

  • Pregnant and lactating females,

  • Patients with anticipated difficult airways,

  • Patients with known allergy to the study medication,

  • Any modifications required to the anesthesia procedure,

  • Laryngoscopy duration lasting longer than thirty seconds.

Fifty participants will be allocated evenly across two distinct categories, with group M receiving an intravenous dosage of magnesium sulphate (45 mg/kg) in 10 ml of normal saline. The group P – with the control population, will receive normal saline in the same quantity.

Sample size calculation

The website openepi.com was used to calculate the sample size (see Figure 1). Presuming mean arterial pressure immediately after intubation, a sample of 19 patients will be required to detect a minimum of 10% difference in the mean arterial pressure. The study will be conducted on a total of 50 patients to account for any possible dropouts.

0179e8be-fc8b-4e95-ae52-3472a94cc9d1_figure1.gif

Figure 1. Sample size for comparing two means.

Intervention

Prior to the procedure, a thorough pre-operative evaluation will be conducted. This will include monitoring vital signs, reviewing the outcomes of routine laboratory tests, and reviewing imaging study results. Additionally, a comprehensive systemic and general examination will be carried out. Before the procedure begins, patients will be given instructions to fast, commencing at midnight, and they will be given an oral dose of 0.5 mg of Alprazolam. Patients will be randomly assigned to one of two groups, each with 25 patients when they arrive in the operation room. An 18-gauge catheter will be used to cannulate a suitable peripheral vein. Following this, baseline vital signs will be recorded, and continuous monitoring of the ECG, non-invasive blood pressure, and pulse oximetry will commence. Pre-medication will be administered with 0.004 mg/kg of Glycopyrrolate, 0.08 mg/kg of Ondansetron, and 0.04 mg/kg of Midazolam given 10 minutes prior to induction. 100% oxygen will be used for pre-oxygenation via a mask. Before induction, the study drug will be administered over a period of one minute. Intravenous injections of propofol (around 2 mg/kg) till unconsciousness ensues, fentanyl (2 μg/kg), and vecuronium (0.1 mg/kg) to provide muscle relaxation will be used to induce general anesthesia. After the vecuronium injection, tracheal intubation will be performed around three minutes later. An expert anesthesiologist will perform the laryngoscopy utilizing a Macintosh curved blade laryngoscope, and an appropriate cuffed endotracheal tube will be used for orotracheal intubation. The study will only involve patients successfully intubated in a single attempt within 30 seconds. Surgical stimulation won’t be initiated until at least five minutes after the intubation. Positive pressure ventilation and 1.5% sevoflurane combined with a 50% oxygen-in-air mixture in a closed circuit will be used to maintain anesthesia. Fentanyl (1 μg/kg) will be administered for intraoperative analgesia, and lung ventilation will be adjusted to keep the end-tidal CO2 level at a range of 35 and 40 mmHg. After the procedure, IV neostigmine (0.04 mg/kg) and glycopyrrolate (0.002 mg/kg) will be used to reverse muscle relaxation. Notably, there will be no measurements of serum levels of magnesium sulphate (MgSO4) at any stage of the investigation.

Hemodynamic measures such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial blood pressure (MAP) will be monitored at predetermined intervals during the laryngoscopy procedure. These time intervals comprise baseline assessments, post-administration of study drugs, and the first, third, and fifth minutes following intubation. Any episodes of arrhythmias, tachycardia, hypertension, or hypotension will be recorded. The rate-pressure product (RPP), computed as the product of HR and SBP, will be ascertained at the abovementioned intervals.

Statistical analysis

Analyzing and reporting data will involve comparing the two groups’ primary and secondary outcomes using the relevant statistical tests (e.g., chi-square test, t-test, Mann-Whitney U test).

If appropriate, subgroup analyses and multivariate regression models will be done. The relevant statistical program will be used for data analysis. The CONSORT criteria will be followed in reporting the results.

Dissemination

Article from this study will be published in an indexed journal

Data collection

The data gathered from the observations, such as hemodynamic parameters and adverse effects, will be compared to the other group.

Study status

Data collection is ongoing.

Discussion

This research protocol aims to add to the growing body of information on physiological stress response attenuation during tracheal intubation and laryngoscopy. In this discussion, we examine the results from previous studies, drawing similarities and contrasts and determining the potential importance of our research. The effectiveness of intravenous magnesium sulphate in decreasing heart rate and arterial blood pressure to laryngoscopy in patients having head and neck procedures was reported by Sunil et al.13 This study established the foundation for magnesium sulfate’s potential usage. According to Misganaw et al.,14 administering magnesium sulphate and lidocaine pre-emptively effectively reduced the hemodynamic reactions caused by laryngoscopy and intubation. Notably, this study assessed the relative efficaciousness of lidocaine and magnesium sulphate, offering valuable information. In a dose-response investigation, Honarmand et al.15 discovered that magnesium sulphate, given in varying amounts, significantly reduced fluctuations in arterial pressure after laryngoscopy and intubation. Alterations in heart rate, however, were not significantly impacted. To assess the effectiveness of sublingual nitroglycerin and magnesium sulphate in reducing pressor responses, Kotwani et al. conducted a study.7 They discovered that both therapies were successful despite a brief increase in heart rate, highlighting that these responses were dose-dependent. The research conducted by Sen and Sen (2022) presents dexmedetomidine as a viable prophylactic method for reducing hemodynamic reactions to laryngoscopy and intubation during neurosurgery.6

If the proposed study’s results are per previous studies, they could have significant therapeutic implications. They might result in the development of consistent regulations for controlling physiological responses to stress during tracheal intubation and laryngoscopy. Physicians could choose interventions, dosage, and patient groups with more excellent knowledge. It is critical to recognize the possible drawbacks demonstrated by the preceding investigations, including individual variability and the setting of the processes. More research needs to be employed to understand the dose-dependent transitory rise in heart rate.

In summary, the study protocol can significantly contribute to the fields of anesthesia and critical care. It broadens previous research findings, provides fresh perspectives on dosage, and presents a novel strategy, giving medical professionals access to a broader range of therapeutic options. With the potential to improve patient outcomes and safety during laryngoscopy and tracheal intubation, the approach holds significant potential to enhance patient safety.

Ethical considerations

Ethical approval for conducting this study was sought from the Institution Ethics Committee Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, Maharashtra, India. Before the approval of the protocol, there was a comprehensive review of the objectives, methodology, risks and benefits that the participants may encounter, and adherence to ethical guidelines was established by the committee. The Institutional Ethical Committee has approved the conduct of the study with the reference number – DMIMS (DU)/IEC/2022/92 dated 20/07/2022. This ethics statement would serve as a declaration of the researchers’ dedication to ethically conducting the study without causing harm to any of the participants involved in the study.

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Sawant U, Sen J and Paul A. Evaluation of intravenous magnesium sulphate on haemodynamic responses to laryngoscopy and tracheal intubation in surgeries of ear, nose and throat [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:455 (https://doi.org/10.12688/f1000research.144517.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 07 May 2024
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3
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Reviewer Report 11 Jul 2024
Imen Zouche, University of Sfax, Sfax, Tunisia;  Department of Anesthesia, Habib Bourguiba University Hospital, Sfax, Tunisia 
Approved with Reservations
VIEWS 3
Introduction
The introduction section of the article "Evaluation of Intravenous Magnesium Sulphate on Haemodynamic Responses to Laryngoscopy and Tracheal Intubation in Surgeries of Ear, Nose and Throat" is notably lengthy. However, it lacks a clear statement of the study's ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Zouche I. Reviewer Report For: Evaluation of intravenous magnesium sulphate on haemodynamic responses to laryngoscopy and tracheal intubation in surgeries of ear, nose and throat [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:455 (https://doi.org/10.5256/f1000research.158323.r297600)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
5
Cite
Reviewer Report 24 Jun 2024
Wadii Thabet, Otorhinolaryngology, University of Monastir Faculty of Medicine of Monastir, Monastir, Monastir, Tunisia 
Approved with Reservations
VIEWS 5
The article is a study protocol. It is well-written. The subject is very interesting. The main objective of the article is to assess magnesium sulfate’s influence on cardiovascular responses during laryngoscopy and orotracheal intubation. I think that this study protocol can ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Thabet W. Reviewer Report For: Evaluation of intravenous magnesium sulphate on haemodynamic responses to laryngoscopy and tracheal intubation in surgeries of ear, nose and throat [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:455 (https://doi.org/10.5256/f1000research.158323.r289047)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 07 May 2024
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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