Comparison of two doses of magnesium sulphate as sedative during awake fiberoptic intubation for patients undergoing maxillofacial surgery: A prospective RCT


Kavita Meena1, Armaanjeet Singh2, Rajesh Kumar Meena3, Dinesh Kumar Singh4
1[kvtamn68@gmail.com] {ORCID:0000-0002-3841-6509}
2[dr.armaanjeetsingh@gmail.com]
3[drrajaiims86@gmail.com]
4[dksbhu@gmail.com]

Department of Anesthesiology, Institute of Medical Sciences, Banaras Hindu University (IMS–BHU), Varanasi, Uttar Pradesh 221005, India

Correspondence: Dr. Rajesh Kumar Meena, Department of Anesthesiology, Institute of Medical Sciences, Banaras Hindu University (IMS–BHU), Aurobindo Colony, Banaras Hindu University Campus, Varanasi, Uttar Pradesh 221005, India.

E-mail: drrajaiims86@gmail.com   Phone: 09643975465   Mobile: 91 9643975465

Received: 19 December 2019, Reviewed: 3 February 2020, Revised: 5 February 2020, Accepted: 5 March 2020

ABSTRACT
Background and objectives: Awake fiberoptic intubation (AFI) is the technique of choice for anticipated difficult intubation via nasal/oral route depending on the type of surgery. Various anesthetic techniques have been used to facilitate AFI, including regional anesthesia, topical anesthesia and sedation. There are few studies regarding the use of magnesium sulphate for this purpose. The aim of our study was to find the efficacy of magnesium sulphate as sedative in patients with maxillofacial trauma undergoing AFI and to establish the dose that provides better sedation.
Methodology: 80 patients with maxillofacial trauma scheduled to undergo open reduction and internal fixation were included in this randomized control trial. The patients were randomly divided into two groups. Group M1 received inj MgSO4  30 mg/kg  in 100 mL NS and Group M2 received inj MgSO4 45 mg/kg in 100 mL NS over 10-15 min before surgery. Sedation was assessed using Ramsay Sedation Score.
Result: The sedation scores were found to be higher in Group  M2 as compared to Group  M1, which was statistically significant (p < 0.006). On comparison of hemodynamic parameters before and after intubation, more blunting of hemodynamic response seen with 45 mg/kg MgSO4.
Conclusion: Magnesium sulphate provides good sedation for awake fiberoptic intubation in patients with maxillofacial trauma, and a dose of 45 mg/kg of magnesium sulphate provides deeper sedation as compared to 30 mg/kg.
Key words: Difficult airway; Awake fibreoptic intubation; Magnesium sulphate; Hemodynamics
Citation: Meena K, Singh A, Meena RK, Singh DK. Comparison of two doses of magnesium sulphate as sedative during awake fiberoptic intubation for patients undergoing maxillofacial surgery: A prospective RCT. Anaesth. Pain intensive care 2020;24(2): 175-182

DOI: https://doi.org/10.35975/apic.v24i2.1254

INTRODUCTION

Maxillofacial surgeries are challenging for anesthesiologists due to profuse bleeding, facial edema, restricted mouth opening and other airway complications. Awake fiberoptic intubation (AFI) is the technique of choice for these cases via nasal/oral route depending on the type of surgery.1
There is reduced risk of aspiration with AFI, since the protective reflexes of the airway are maintained until just before an endotracheal tube is passed into the trachea. A nasal cannula can be used to deliver oxygen during sedation and intubation to prevent hypoxia.
Various techniques have been used to facilitate AFI, including regional anesthesia, topical anesthesia and sedation. Sedative medications decrease anxiety, ensuring patient’s cooperation and a patent airway with adequate oxygenation and ventilation. Patient’s response to fiberoptic scope advancement and tracheal intubation is blunted.
Numerous sedative drugs, either alone or in combination, have been used as an adjunct to AFI. Benzodiazepines together with opioids can achieve adequate patient comfort during intubation and sedation. Opioids like morphine or fentanyl provide analgesia and depress laryngeal reflexes. However, they are associated with respiratory depression. Other pharmacological agents include midazolam, fentanyl, dexmedetomidine and 2magnesium sulphate.
Magnesium plays an important role in a multitude of physiologic processes. Since the pioneer study of magnesium sulphate in clinical anesthesia in 1996, the drug has piqued interest in the field of anesthesia and pain medicine. Magnesium is the fourth commonest cation in a human body. It has a key role in a variety of physiologic processes. Among the numerous actions of magnesium, the blockade of calcium channels and N-methyl-D-aspartate (NMDA) receptor is significant in anesthesia. Magnesium sulphate has been used in preeclampsia patients to prevent seizure. It is also used for the treatment of arrhythmia, asthma, and as an anesthetic adjunct in patients undergoing surgery for pheochromocytoma and laparoscopic cholecystectomy.3,4
There is scarce literature regarding the use of magnesium sulphate as a sedative for AFI. In this study we aim to find the efficacy of magnesium sulphate as sedative in patients with maxillofacial trauma undergoing AFI and to compare two different doses of the medication.

METHODOLOGY

This study was conducted in the department of Anesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, after obtaining the ethical committee approval. Written informed consent was obtained from all patients. 80 patients with maxillofacial trauma, scheduled to undergo open reduction and internal fixation (ORIF), were enrolled in this prospective randomized controlled study. Patients aged 18 to 50 years were included. Patients with lack of consent, previous allergic reaction to MgSO4, co-morbidity, coagulopathy, cervical spine trauma, neurological deficit and pregnancy were excluded from the study.  The patients were divided into two groups using a list of random numbers, generated by a sealed envelope system.
All patients underwent a detailed pre-anesthetic evaluation with all the relevant investigations. They were kept nil per oral according to the recommended guidelines. They were pre-medicated with tab. alprazolam 0.25 mg, tab. ranitidine 150 mg and tab. metoclopramide 10 mg the night before surgery and 2 h before intubation with 1-2 sips of water. An intravenous line was secured with an 18G IV cannula and an infusion was started using Ringer Lactate solution. Patients were administered MgSO4 (30 mg/kg for Group M1 and 45 mg/kg for Group M2) in 100 mL normal saline intravenously over 10-15 min. 10 ml of 2% lignocaine solution was given via nebulization as topical anesthesia. Patients were observed for any adverse effects. After preparation of patients, nasotracheal tube was inserted through the nostril into the oropharynx. A well-lubricated fiberoptic bronchoscope was passed through the tube and manipulated to identify the epiglottis and cords. The bronchoscope was advanced into the trachea to the level of carina and the tube was threaded over it.
The degree of sedation was classified by an experienced observer according to the Ramsay Sedation Score.
Mean arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were monitored. Hypoxemic episodes were defined as SpO2 < 90% and lasting > 10 sec. Apnea was defined as the absence of spontaneous respiration for > 15 sec. If hypoxemia or apnea occurred, spontaneous respiration was encouraged by tactile or vocal stimuli.
If hypotension occurred (MAP decreased > 30% of baseline), 6 mg IV mephentermine was administered. If heart rate decreased to < 50 beats/min, 0.6 mg atropine was given IV.
If patient was too uncooperative or restless, inj propofol was used as a rescue drug to facilitate sedation and smooth intubation.

Statistical Analysis:

The sample size was calculated to be N = 40 based on the following considerations: 95% confidence level and 80% power of the study. Statistical analysis was performed using unpaired T-test for normally distributed parametric data. A p < 0.05 was considered statistically significant.

A7-Fig1
RESULTS

The demographic data, e.g. mean age, height, weight and BMI of the patients in both groups were statistically equivalent in both of the groups. In Group M1 36 (90%) patients were males and in Group M2 38 (95%) were males and 2 (5%) were females (Table 1).
Secondary objectives of the study including mouth opening (p = 0.372), Mallamptti scores 3 and 4 (p = 0.824), and the frequency of comorbid conditions, hypertension or diabetes (p = 0.696) were equivalent in both groups, as shown in Table 2.
Ramsay Sedation Scores were statistically significantly better in Group M2, in that 23 (57.5%) patients scored 2 and 3, compared to 11 (27.5%) patients in Group M1 (p = 0.006) as shown in Table 2.
Majority of the patients in Group M1 scored 1 [29 (72.5%)] as compared to Group M2 [17 (42.5%)] (p = 0.006) as shown in Table 2 and Figure 2.

Table 1: Demographic parameters
Parameter Group M1 Group M2 p-value
Mean Age 28.70 ± 8.936 29.30 ± 8.718 0.762
Gender M/F 36/4 38/2
Weight 67.13 ± 11.170 65.08 ± 11.079 0.412
Height 164.18 ± 9.721 163.80 ± 8.389 0.854
BMI 24.959 ± 4.072 24.437 ± 4.952 0.304
ASA Grade Grade I = 30 Grade I = 32 0.299
Grade II = 10 Grade II = 8
Table 2: Results of secondary objectives in Groups M1 and M2
Parameter Group M1(n = 40) Group M2 (n = 40) p-value
Mouth Opening
1 finger 19 (47.5%) 15 (37.5%) 0.372
2 fingers 21 (52.5%) 25 (62.5%)
MPG
3 22 (55%) 15 (57.5%) 0.824
4 18 (45%) 25 (42.5%)
Comorbidity
Hypertension 2 (5%) 4 (10%) 0.696
Diabetes 2 (5%) 2 (5%)
Ramsay Sedation Score
1 29 17 0.006
2 8 14
3 3 9
A7-Fig2

Hemodynamic parameters  e.g.  HR,  MAP, EtCO2,  SpO2, Peak Airway Pressure and respiratory rate (RR) were measured preoperatively,  after MgSO4 administration and after AFOI. Data are given in Table 3. The  differences in between both groups was statistically not significant. MAP and HR in both groups has been graphically depicted in Figure3

Table 3: Summary of vital signs (Data given as Mean ± SD)
Parameter Group M1 (n=40) Group M2 (n=40) t-value p-value
 HR: Preoperative 83.58 ± 9.551 81.20 ± 12.934 0.934 0.353
HR after MgSO4 administration 86.28 ± 10.466 82.70 ± 11.815 1.432 0.156
HR after AFOI 90.53 ± 9.348 85.95 ± 10.919 2.013 0.048
MAP; Preoperative 91.45 ± 12.850 88.50 ± 11.852 1.067 0.289
MAP after MgSO4 administration 86.70 ± 9.296 83.15 ± 8.601 1.773 0.080
MAP after AFOI 89.25 ± 6.126 84.88 ± 11.872 2.071 0.042
EtCO2; Preoperative 35.50 ± 3.226 34.45 ± 3.351 1.428 0.157
EtCO2 after MgSO4 administration 35.45 ± 3.129 35.85 ± 3.134 -0.571 0.570
EtCO2 after AFOI 35.20 ± 3.098 34.90 ± 3.053 0.436 0.664
SpO2; Preoperative 98.10 ± 1.516 97.60 ± 1.516 1.475 0.144
SpO2 after MgSO4 administration 97.40 ± 1.722 97.80 ± 1.588 -1.080 0.283
SpO2 after AFOI 97.93 ± 1.289 97.90 ± 1.499 0.080 0.936
Peak Airway Pressure; Preop 16.50 ± 2.124 16.98 ± 1.941 -1.044 0.300
Peak Airway Pressure after MgSO4 16.65 ± 2.143 17.23 ± 2.044 -1.228 0.223
Peak Airway Pressure after AFOI 17.43 ± 1.824 17.15 ± 1.942 0.653 0.516
RR; Preoperative 17.28 ± 2.025 17.08 ± 1.966 0.448 0.655
RR after MgSO4 administration 16.85 ± 1.902 17.35 ± 1.916 -1.171 0.245
RR after AFOI 17.40 ± 2.170 17.20 ± 1.884 0.440 0.661
HR = Beats/min; MAP = mmHg; EtCO2 = mmHg; Peak Airway Pressure = cmH2O; RR = Breaths/min

A7-Fig3
DISCUSSION

AFI is the gold standard for management of difficult airway. It can be an unpleasant experience for the patient even with meticulous application of local anesthetic. Conscious sedation is desirable not only to make the procedure more tolerable for patients but also to ensure optimal intubation conditions, particularly in the presence of abnormal laryngeal anatomy and physiology. A major challenge during AFI is to provide adequate sedation while maintaining patent airway and spontaneous ventilation. Deep sedation can result in loss of airway with serious consequences. We successfully used this drug foe adequate sedation for AFI in our patients. It may be used as a single IV drug with upper airway nebulization with lignocaine solution or with other sedatives, where it would impart the advantage of reducing the doses of all sedative drugs.
Magnesium is the fourth most abundant cation in the body and the second most abundant intracellular cation. It acts as a natural antagonist to calcium ions regulating their access into the cell. It can be used to prevent and alleviate pain by acting as an antagonist at N-methyl-D-aspartate receptors.
The study of Tramer et al. demonstrated the significance of magnesium as an adjuvant in post-operative analgesia. Patients receiving magnesium had a lower requirement of morphine and had comparatively less discomfort during first 48 h postoperatively than those receiving morphine alone. Multiple incidences of respiratory depression occurred in the group receiving morphine only versus none in the group given a regime of morphine and magnesium.5 Koinig et al. reported similar results, with a decreased requirement of intra-operative and post-operative analgesia.6
In the present study, lesser rise in heart rate and mean arterial pressure was noted in Group  M2 as compared to Group  M1 following AFI. Sedation provided by magnesium sulphate was more profound and suitable for AFI at a dose of 45 mg/kg as compared to the dose of 30 mg/kg. Similar results were found in a study conducted by Panda et al.7
Magnesium is considered to be a muscle relaxant like agent. Neuromuscular transmission is impaired by diminution in the release of acetylcholine at motor nerve terminal. A clinical study demonstrated that a rapid infusion of MgSO4 (50 mg/kg) can re-establish relevant degree of muscle paralysis in patients who have just recovered from non-depolarizing blocking agents.8
In patients with tetanus MgSO4 infused at doses maintaining serum concentrations of 2-4 mmol/L allowed good control of spasm and muscle rigidity.9
Magnesium reduces the release of acetylcholine from motor nerve terminal, resulting in diminished excitability of the muscle fiber itself and decrease in the amplitude of the end plate potential. It therefore, potentiates the non-depolarizing neuromuscular blocking agents.
Magnesium impairs the release of catecholamine from the adrenal medulla and adrenergic nerve endings. It attenuates the vasopressor response to laryngoscopy and intubation.
Choi et al. concluded that IV magnesium sulphate reduced propofol infusion requirements. It may perhaps be related to the sedative effect of magnesium. Magnesium has been reported to induce general anesthesia and to potentiate the activity of local anesthetic agents.10 A narcotic state inhuman being undergoing surgical operations was achieved in a study by Peck and Meltzer who reported three patients undergoing hernioplasty under general anesthesia by MgSO4 infusion.11
MgSO4 has added a new dimension to the administration of anesthesia, whether it is GA or regional or local anesthesia. The anesthesiologists can now enjoy more flexibility in the show of their art.

CONCLUSION

The use of magnesium sulphate as sedative produces adequate sedation scores in patients with maxillofacial trauma undergoing awake fiberoptic intubation, but the scores were found to be significantly higher with 45 mg/kg use as compared to 30 mg/kg. On comparing the hemodynamic parameters before and after intubation it was noted that there was more blunting of hemodynamic response with 45 mg/kg MgSO4. No respiratory depression was observed in either groups; both had preserved patency of airway. Overall MgSO4 is a safe and effective drug to provide sedation during awake fiberoptic intubation with minimal side effects.

Conflict of interest: None declared by the authors.
Authors’ contribution:
KM – Manuscript editing
RM – Concept of study, statistical analysis
AS, DKS – Conduct of study

REFERENCES
  1. Collins SR, Blank RS. Fiberoptic Intubation: An Overview and Update. Respir Care. 2014 Jun;59(6):865-78; discussion 878-80. [PubMed] DOI: 4187/respcare.03012
  2. Khaskheli MS, Tabassum R, Awan AH. Effectiveness of magnesium sulphate in acute asthma: a retrospective study. Anaesth Pain Intensive Care. 2017;21(4):458-62. [Free full text]
  3. Do SH. Magnesium: a versatile drug for anesthesiologists. Korean J Anesthesiol. 2013;65(1):4–8. [PubMed] DOI: 4097/kjae.2013.65.1.4
  4. Bansal K, Santpur MU, Garg U, Goel K, Vijay D, Tatineni Bansal. Effect of intravenous magnesium sulphate on hemodynamic response to pneumoperitoneum in laparoscopic cholecystectomy: A prospective, double blind study. Anaesth Pain Intensive Care. 2019;23(3):290-29 [Free full text] DOI: 35975/apic.v23i3.1138
  5. Tramer MR, Schneider J, Marti RA, Rifat K. Role of magnesium sulfate in postoperative analgesia. Anesthesiology. 1996;84(2):340–7. [PubMed] DOI: 1097/00000542-199602000-00011
  6. Koinig H, Wallner T, Marhofer P, Andel H, Hörauf K, Mayer N. Magnesium sulfate reduces intra-and postoperative analgesic requirements. Anesth Analg. 1998;87:206–10. [PubMed] DOI: 1097/00000539-199807000-00042
  7. Panda NB1, Bharti N, Prasad S. Minimal effective dose of magnesium sulfate for attenuation of intubation response in hypertensive patients. J Clin Anesth. 2013 Mar;25(2):92-7. [PubMed] DOI: 1016/j.jclinane.2012.06.016
  8. Hans GA, Bosenge B, Bonhomme VL, Brichant JF, Venneman IM, Hans PC. Intravenous magnesium re-establishes neuromuscular block after spontaneous recovery from an intubating dose of rocuronium: A randomised controlled trial. Eur J Anaesthesiol. 2012;29(2):95–9. [PubMed] DOI: 1097/EJA.0b013e32834e13a6
  9. Rodrigo C, Fernando D, Rajapakse S. Pharmacological management of tetanus: an evidence-based review. Crit Care. 2014;18(2):217. [PubMed] DOI: 1186/cc13797
  10. Choi JC, Yoon KB, Um DJ, Kim C, Kim JS, Lee SG. Intravenous magnesium sulfate administration reduces propofol infusion requirements during maintenance of propofol-N2o anesthesia: part i: comparing propofol requirements according to hemodynamic responses: part ii: comparing bispectral index in control and magnesium groups. Anesthesiology. 2002;97(5):1137–41. [PubMed] DOI: 1097/00000542-200211000-00017
  11. Peck CH, Meltzer SJ. Anaesthesia in human beings by I.V. injection of MgSO4. J Am Med Assoc. 1916;601:1131–3