|Ahead of print publication
Evaluation of the efficacy of turmeric-based lozenges for the prevention of postoperative sore throat in surgeries done under laryngeal mask airway insertion
Shehla Naseem, Divya Gupta, Harish Koshyari
Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India
|Date of Submission||21-Mar-2022|
|Date of Decision||14-Jul-2022|
|Date of Acceptance||19-Jul-2022|
|Date of Web Publication||06-Sep-2022|
Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Rama Nagar, Doiwala, Dehradun, Uttarakhand
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Context: Sore throat is a common complaint to both laryngeal mask airway (LMA) insertion and endotracheal tube intubation. Its incidence in LMA has been found to vary between 5.8% and 34%. Administration of medicated lozenges in the preoperative period is also a route available for the prevention of postoperative sore throat (POST). Aim: The aim of this double-blinded randomized controlled study was to evaluate the efficacy of turmeric-based lozenges given preoperatively in patients undergoing general anesthesia (GA) under LMA insertion for the prevention of POST. Settings and Design: This study was conducted at the Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Rama Nagar, Dehradun, over a period of 12 months. Subjects and Methods: Two hundred and fifty patients of the American Society of Anesthesiologists classes I and II posted for elective surgeries under GA with insertion of LMA were included in our study. Randomization was done by the sealed envelope technique. Turmeric extract with menthol and eucalyptus oil lozenges was given in Group A (n = 125), while plain turmeric extract with orange flavor lozenges was given in Group B (n = 125) 30 min preoperatively. The patients were assessed for POST in the recovery room post-LMA removal at 30 min, 6 h, 12 h, and 24 h. Statistical Analysis: The data were analyzed using Chi-square test, Fisher's exact test, and Student's t-test. P < 0.05 was considered statistically significant. Results: The turmeric lozenges containing 6.4 mg eucalyptus oil and 6.3 mg menthol oil along with turmeric extract 100 mg significantly reduced the incidence of POST across all time intervals (P < 0.05) as compared to orange-flavored plain turmeric lozenges containing turmeric extract 100 mg. Conclusions: POST was reduced with preoperatively administered eucalyptus oil and menthol oil containing turmeric lozenges.
Keywords: General anesthesia, laryngeal mask airway, sore throat, turmeric-based lozenges
|How to cite this URL:|
Naseem S, Gupta D, Koshyari H. Evaluation of the efficacy of turmeric-based lozenges for the prevention of postoperative sore throat in surgeries done under laryngeal mask airway insertion. Anesth Essays Res [Epub ahead of print] [cited 2022 Oct 2]. Available from: https://www.aeronline.org/preprintarticle.asp?id=355666
| Introduction|| |
The laryngeal mask airway (LMA) use is associated with various complications such as aspiration, airway trauma, loss of the airway on insertion, failed insertion, displacement after insertion, loss of airway during maintenance, and a common problem of sore throat. Postoperative sore throat (POST) is a common problem to both LMA and endotracheal tube (ETT) with variable incidence. Its incidence in LMA has been found to vary between 5.8% and 34%. The lowest incidences of POST have been reported with LMA I-gel.
The LMA was initially designed to be introduced with cuff deflated entirely, which significantly lowered the patient's satisfaction and affected their postdischarge activities negatively. In another technique, the cuff of LMA is moderately inflated with a “fixed volume” of air before insertion which lowers the incidence of POST by decreasing soft tissue trauma in the pharynx and mouth.
Li et al. conducted a study on the relationship between the cuff inflating volume and the intracuff pressure for size 4 or 5 LMA Well Lead™ and concluded that the minimal cuff inflating volume is adequate for satisfactory airway sealing and consequently associated with a lower incidence of postoperative pharyngeal complications.
Various clinical studies have been done to minimize the morbidity caused by POST such as the use of tramadol gargles, low dose atracurium, lidocaine gel, lidocaine inhalation and intravenous steroids after LMA insertion. Use of medicated lozenges, before LMA insertion, is also a route available for the prevention of POST. Lozenges are intended to be allowed to dissolve on the rear surface of the mouth to provide drug delivery locally to minimize systemic and maximize local drug activity. Upon sucking, they dissolve slowly in the mouth and release their ingredients for local action.
Farhang and Grondin conducted a study to evaluate the effects of administration of zinc lozenges on POST. The administration of a single dose of 40-mg zinc lozenge 30 min preoperatively was effective to reduce both incidence of POST in the first 4 h and severity of mild and moderate POST in the immediate postoperative period.
Borazan et al. also conducted a study, which aimed to investigate the effect of preoperative administration of oral magnesium lozenge on POST to conclude that the administration of magnesium lozenge 30 min preoperatively is effective to reduce both incidence and severity of POST in the immediate postoperative period.
Turmeric is well known for its effect on sore throat and is used as a natural remedy since ages. It contains curcumin which is delivered in bloodstream bypassing the gut through buccal absorption. It is a highly lipophilic and highly impermeable drug which has natural antibacterial, antiseptic, antioxidant, and anti-inflammatory effects. Menthol, having local anesthetic and soothing qualities, is a compound obtained from oils of corn mint or peppermint. It is commonly used to relieve minor throat irritation. It also acts as a weak kappa opioid receptor agonist. It can be used either alone as a topical analgesic or combined with compounds such as eucalyptus oil (natural decongestant) to increase its efficacy. No study has been done so far on the effect of these mouth-dissolving turmeric lozenges on POST. However, only one study has been done so far, using flurbiprofen lozenges to reduce the incidences of POST compared to placebo lozenges after LMA insertion.
To evaluate the incidences of POST in our study, turmeric-based lozenges were administered 30 min preoperatively in surgeries done under LMA insertion. Patients were asked to suckle the lozenges in the preoperative period and to spit out any leftover lozenge before shifting to operation theater (OT). We planned our study for comparison of the efficacy of turmeric lozenges having menthol oil and eucalyptus oil with lozenges having only turmeric to look for any synergistic effect among the components of lozenges in the prevention of POST.
| Subjects and Methods|| |
This study was conducted at the Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Ram Nagar, Dehradun, over a time period of 12 months. This was a randomized double blind controlled study conducted after obtaining Institutional Ethical Committee Clearance (SRHU/HIMS/ETHICS/2021/109 dated 12/10/2021). The written informed consent was taken from the patients for active participation in the study and use of patient data for research and educational purposes. The study was registered prospectively in the Clinical Trial Registry India (CTRI/2020/09/027640) and all the procedures followed the guidelines laid down in the Declaration of Helsinki (1964).
- Type of the study: Randomized double-blinded controlled study
- Sample size and sampling methods: Sample size was calculated using formula as using proportions: inequality and two independent groups using G-Power software
- Proportion P1 = 0.34 Proportion P2 = 0.50, α-10% level of significance power (1-β) = 0.80 N = 250
- Therefore, 125 cases in each group.
Selection of subject
- Either sex
- Patients in the age group of 20–65 years
- American Society of Anesthesiologists Physical status class I and II
- Elective. Surgical procedures (up to 90 min), requiring GA with LMA insertion.
- Patients with active upper respiratory tract infection
- Emergency cases
- Surgeries of oral cavity and pharynx
- Mallampati Grade III and IV
- Anticipated difficult intubation
- More than 1 attempt for LMA insertion
- Obesity (body mass index >30 kg.m−2)
- Gastroesophageal reflux disease
- Patients with significant cardiovascular and respiratory diseases such as asthma and chronic obstructive pulmonary disease
- Patients with significant preoperative derangement of renal/hepatic functions
- Any reaction to study drugs (turmeric and menthol).
- Ambu® AuraGain™ disposable LMA (third generation supraglottic airway device)
- Turmeric-based lozenges
- Water-soluble jelly
- Portex® cuff manometer
- Ramsay Sedation Score.
- Thorough preanesthetic assessment was done of all the patients eligible for the study. A history regarding any previous surgeries or comorbidities was elicited. Selected patients were divided into two groups onto medication administered
- Turmeric lozenges (test group) (n = 125) containing turmeric extract (Curcuma longa), menthol oil, and eucalyptus oil (Turmnova, Gelnova Laboratories (India) Pvt. Ltd.)
- Group B: Turmeric lozenges with orange flavor (Turmgel, Gelnova Laboratories (India) Pvt. Ltd.), as control group (n = 125)
- Randomization was done by the sealed envelope technique. The sealed envelope was handed over to the person in the preoperative room who was unaware of the group of lozenge. Furthermore, the anesthesiologist attempting insertion in the OT was unaware of the type of lozenge received by the patient. The patients were kept Nil By Mouth for solids for at least 6 h before surgery. All the patients were medicated one night before surgery and in the morning
- In the preoperative area, the patients were given lozenges at least 30 min before surgery. Before shifting the patient to the operating room, patients were instructed to spit out any leftover lozenge. Inside OT, after establishing intravenous access, all the monitors were attached on the patient and “baseline reading” of heart rate, electrocardiograph, systolic and diastolic blood pressure, mean arterial pressure, oxygen saturation, and end-tidal carbon dioxide were noted. Patients were preoxygenated with 100% oxygen for 3 min.
- Before inserting LMA, it was lubricated on its posterior aspect, with Water soluble lubricating jelly (Lubic® by NEON) to facilitate its easy insertion. The process was completed by inserting low-pressure, high-volume cuffed Ambu® AuraGain™ LMA. Size was decided according to the patient's weight. The cuff of the LMA was filled with air (15–20 mL air for size 3 and 25–30 mL air for size 4) to maintain cuff pressure of ≤25 mmHg as assessed by the Portex® cuff manometer
- Intraoperatively, vitals were monitored and anesthesia was maintained with 50:50 oxygen and air, while sevoflurane (0.6%–0.8%) dial setting was adjusted according to the hemodynamic statuses of patients. Intermittent boluses of intravenous atracurium 0.05 mg.kg–1 and intravenous fentanyl 1 μg.kg–1 were also given as needed
- The last dose of opioid analgesic was given around 30 min before the estimated LMA removal and the patients were administered intravenous paracetamol 1 g and intravenous diclofenac 75 mg as preemptive rescue analgesia. The inhalational agent was switched off 10 min before LMA removal
- After initiation of spontaneous breathing, air switched off and were permitted for breathe spontaneously along with 100% oxygen. When patients regained consciousness with adequate spontaneous respiration, LMA was taken out after half deflating its cuff. Single gentle oral suction was done once, after the removal of LMA. The patients were administered 100% oxygen by face mask for another 2–3 min. After assessing patients' vitals, patients shifted to postanesthesia care unit (PACU)
- Patients were assessed for POST, when Ramsay Sedation Score was 2 (cooperative, oriented, and tranquil), after shifting from the OT to PACU. Patients were assessed for POST at 30 min after the removal of LMA followed by reassessment at 6 h, 12 h, and 24 h later by the same anesthesiologist in all the cases. The assessment of the POST was done by scoring system as given by Harding and McVey [Table 1].
Data management and statistics
The data were gathered and written in Microsoft Excel 2010. Various statistical analyses were performed using IBM Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. (Armonk, NY: IBM Corp.). Using. parametric tests, normally distributed data were calculated, while the nonnormally distributed data were analyzed using nonparametric tests. For quantitative variables, descriptive statistics were calculated. Frequencies along with their percentages were computed for both the qualitative and categorical variables. Graphical representation of the variable was shown to apprehend the results clearly and the categorical data were analyzed using Chi-square test. If P < 0.05, the hypothesis was said to be statistically significant, and if P > 0.05, the hypothesis was said to be statistically insignificant.
| Results|| |
In our study, over a period of 12 months, 250 patients were allocated and assessed for eligibility. A total of 11 patients were excluded on the basis of exclusion criteria. 120 patients were selected in Group A and 119 patients in Group B. The demographic profile of patients is tabulated in [Table 2] and the characteristics of LMA insertion are tabulated in [Table 3]. On assessing the POST at 30 min, 6 h, 12 h, and 24 h, the results as documented in [Table 4] were obtained wherein the comparison of POST at different time intervals between the two groups demonstrated a significant reduction of POST in Group A as compared to Group B across all time intervals.
|Table 4: Comparison of sore throat at different time intervals between two groups|
Click here to view
| Discussion|| |
To reduce the incidences of POST associated with LMA insertion, various modalities have been used such as different techniques of LMA insertion, various methods of lubrication, tramadol gargles, use of neuromuscular blocking agents, or the use of medicated lozenges. Chairatthanawanit et al. also compared POST in patients posted for surgery under LMA insertion by spraying it with either 0.3% benzydamine hydrochloride or normal saline.
Lozenges are a novel way of reducing POST associated with airway instrumentation. Many studies were conducted using lozenges to decrease POST after endotracheal intubation, but to the best of our knowledge, only one study was done so far using flurbiprofen lozenges to reduce the incidences of POST after LMA insertion.
In our study, we used two types of turmeric lozenges Turmgel containing plain turmeric extract 100 mg only and TurmNova containing turmeric extract 100 mg, 6.4 mg eucalyptus oil, menthol oil (peppermint camphor) 6.3 mg, to determine their effectiveness in reducing POST after LMA insertion. These are the world's first and only mouth-dissolving turmeric lozenges which are pleasantly flavored and sugar-free demulcents.
Curcuma longa (turmeric) since ages has anti-inflammatory properties, antiseptic properties, antioxidant activity, antimetabolic syndrome, and anticancer activity. It has been used as a typical treatment for cough, common cold, sore throat, and other respiratory ailments. Menthol extracted from the leaves of Mentha piperita possesses antiallergenic, antibacterial, antiviral, antioxidant, and cytotoxic activities. The leaf extracts of eucalyptus exhibit various biological effects, such as antibacterial, antihyperglycemic, and antioxidant activities. The combination of all these three ingredients was used to see their efficacy in reducing POST after LMA insertion.
Jaensson et al. conducted a study on the effect on POST and hoarseness following ETT or LMA in different genders and found that the incidence of POST was more in women when LMA was used, whereas when women were intubated with ETT, there was no significant differences in POST between genders. In our study, the total number of patients was 125 each with male: female ratio being 90:30 in Group A and 94:25 in Group B.
Grady et al. conducted a study on LMA-induced pharyngolaryngeal injury within the patients breathing spontaneously. They found, at 24-h postoperatively, higher incidence of POST in male patients after the use of a LMA size 5. In our study, we selected the size of the LMA according to weight. The characteristics of LMA insertion showed no impact on POST after LMA insertion. The attempts at LMA insertion or the duration of LMA insertion, duration of surgery, and duration of anesthesia showed no significant difference between the two groups; therefore, the two groups were comparable in LMA insertion characteristics.
In our study, the eucalyptus and menthol-containing turmeric lozenges showed positive results in reducing POST at all time intervals but more so at 30 min postoperatively (P = 0.001), thus signifying that TurmNova lozenges showed earlier beneficial effects in reducing POST as compared to Turmgel lozenges.
Uztüre et al. conducted the study on flurbiprofen lozenges in POST after insertion of ProSeal™. They observed statistically significant results at 30 min of postoperative period (P = 0.026), while the results were nonsignificant at other time intervals, i.e., 4 h, 12 h, and 24 h. In our study, the lozenges showed a significant reduction of POST at 6 h, 12 h, and 24 h (P = 0.01, P = 0.04, and P = 0.03, respectively).
Considering 30 min as our baseline point of observation, our study showed that there was no change in severity score of POST among 56% in Group A and 40% Group B at 6 h postoperatively; however, the decrease in severity score of POST was observed among 44% in patients in Group A as compared to among 60% of patients in Group B. It depicts that the severity of POST decreases late with Group B (Turmgel), while the effect was shown to be earlier in Group A (TurmNova), thus signifying that eucalyptus and menthol have beneficial and additive effects with turmeric in preventing POST.
In our study, lozenges were given preoperatively 30 min before induction, while in a study done by Uztüre et al., flurbiprofen lozenges were given 45 min before induction. They also followed up the patients for 24 h postoperatively but found nonsignificant results at all time intervals except at 30 min, while in our study, the results were significant at all time intervals.
In another study by Kati et al. using benzydamine hydrochloride in reducing POST after LMA insertion, effect on reduction of POST was observed until 4 h postoperatively, while in our study, the effect was observed until 24 h postoperatively, which was significant at all time intervals.
In our study, we had applied water-soluble jelly (LUBIC) on the posterior surface of LMA before its insertion in both the groups. Various studies have been done on lubrication strategies of LMA to see its impact on POST. McKay et al. compared 3 strategies of lubricating the LMA: water-soluble lubricant, 2% lidocaine jelly, and no lubricant as control group and found that no benefit was provided by lubrication of the LMA. Keller et al. compared 2% lignocaine gel with saline as a lubricant for the LMA and found no benefits of lubricating the LMA with lignocaine jelly.
All of the patients found these lozenges palatable and none of the patients reported gastric irritation following sucking of these lozenges. In a study done by Kati et al., the patients complained of coldness and an unknown taste in their throats when the drug was administered.
Overall incidence of POST at 30 min, were 77% and 96% in Group A and B respectively, at 6 h, 51% and 70% in Group A and B respectively, at 12 h, 20% and 31% in Group A and B respectively and, at 24 h, 0.8% and 6% in Group A and B respectively. This signifies that the incidence of POST drastically reduced in Group A from 77% to 57% to 20% to negligible (0.8%) over time period from 30 min to 24 h. However, it reduced in lesser magnitude in Group B from 96% to 70% to 31% to 6%.
As per the literature, so far, no study has been done till now, on the efficacy of turmeric lozenges to decrease the incidence of POST after LMA insertion. Turmeric lozenges are a cheap and convenient way of reducing POST, which is easily acceptable at the patient's front, turmeric being a familiar condiment of each household in India. In our study, turmeric lozenges showed beneficial effects in reducing POST. Eucalyptus and menthol along with turmeric extract in TurmNova lozenges enhanced the soothing and cooling effect, thus relieving the most distressing complaint of POST after airway instrumentation.
Therefore, the incidence of POST was less within Group A (TurmNova) at all the time intervals, but the severity score of POST was improving within Group B (Turmgel) with progressing time intervals postoperatively. Our work depicts better results with Group A at the earliest time interval (i.e., at 30 min postoperatively). Summarily, in our study, in Group A, the incidence of POST with lozenges containing turmeric extract, along with menthol and eucalyptus oil, showed a greater reduction in POST after LMA insertion.
| Conclusions|| |
Lozenges are the novel formulations which are gaining popularity for their immediate, persistent, and prolonged demulcent effects to relieve POST after airway instrumentation with both ETT and LMA insertion. However, effects of the number of attempts, technique of LMA insertion, and the method of LMA lubrication on POST need further study. Turmeric along with menthol and eucalyptus lozenges is a cost-effective method to reduce distressing complications of POST.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]