European Journal of Cardiovascular Medicine

Post-operative sore throat (POST) and hoarseness of voice are very common complaints from patients undergoing endotracheal intubation, the incidence of which has been estimated to be approximately 14.4% to 50%. It has been found to result from an aseptic inflammatory response to irritation of pharyngeal mucosa during laryngoscopy and tracheal intubation. Multiple factors are known to be involved in the high incidence of complaints of post-operative sore throat, hoarseness of voice and cough, like the size of the tracheal tube, design of the cuff, technique of insertion of the tube and high intra-cuff pressure.^1,2 

Use of large sized endotracheal tubes and laryngeal trauma during intubation are common causes of hoarseness of voice and cough post-operatively. Cause of prolonged hoarseness is usually arytenoids cartilage dislocation. High intra-cuff pressure has often been associated with nerve palsies due to neurapraxia and compression of nerves

which has led to sore throat post extubation. Post-operative sore throat seems to be a relatively minor complication, often unaddressed by the clinicians but it affects the overall satisfaction of the patients to a very large extent.³  

No single drug has achieved widespread acceptance in reducing the symptoms. Studies have shown that various modalities like nebulization with ketamine, intracuff , topical or aerosol spray of lidocaine, nebulization or gargle of magnesium sulphate, topical benzydamine, intravenous dexamethasone or hydrocortisone have some efficacy in reducing the symptoms.^4-10 Even though these modalities were effective in curtailing the symptoms, they resulted in development of unwanted adverse effects. Use of ketamine affected hemodynamics and central nervous system of the patient. ²

Budesonide is an ICS commonly used to reduce all these complications. It is a corticosteroid with potent glucocorticoid and weak mineralocorticoid activities. Metered dose delivery of budesonide is considered as simple, less time consuming with high patient acceptability. On the other hand, the main advantage of nebulization with budesonide is that it is deposited directly into the respiratory tract and thus higher drug concentrations can be achieved with fewer adverse effects than when the systemic route is used. They are also helpful when there is trouble using inhaler. ¹¹

The present study was conducted in the Department of Anaesthesiology and Critical Care, Pt. B. D. Sharma PGIMS, Rohtak in a prospective, comparative, randomised and unblinded manner after obtaining approval from the institutional ethical committee and patients’ written, informed consent.   The study included 80 patients of either sex of age 18-60 years, belonging to American Society of Anesthesiologists (ASA) physical status of I-II with Mallampatti score of 1-2, undergoing surgeries under general anaesthesia. Budesonide metered dose inhaler. Before use, the canister of the inhaler was shaken vigorously for about 10 seconds  and was primed by spraying two test sprays in the air. Patients were thereby, asked to breathe out fully and the mouth-piece was placed into the mouth, pursing the lips around it. The patients were asked to breathe in slowly and the canister will be pushed down. The patient were asked to hold the breath for 10 seconds  after which they were asked to breathe out slowly. Each actuation of the canister delivered 200 µg Budesonide IP suspended in chlorofluorocarbon-free propellant. Budesonide respules and apparatus for nebulization with face mask. Before use, the budesonide respule (0.5mg) was shaken gently, held upright and open end of the respule firmly placed inside the nebulizer cup. The solution in a respule was put into a nebulizer and made into a fine mist before it was breathed in. It was then inhaled through face mask. 80 Patients were randomly allotted to one of the two groups equally labelled N and I, of 40 patients each, using random number table as follows:

Group A (n=40):  received 200 µg Budesonide inhalation suspension 30 minutes before intubation, which was repeated 6 hours after extubation.

Group B (n=40):  received 0.5 mg of Budesonide respule via nebulization 30 minutes before intubation which was repeated 6 hours after extubation. Observations:  

In the PACU, all the patients were monitored and vital parameters were recorded.   Budesonide puff 200 µg was repeated again 6 hours after   post-extubation in group A and 0.5mg of budesonide nebulization was repeated in group B . Post-operative sore throat and hoarseness of voice were assessed at 2 hours, 6 hours and 24 hours based on the scales as described below:

Post-operative sore throat was assessed and graded as follows:⁸

Grade 0: No sore throat at any time since the operation

Grade 1: Minimal - patient answered in affirmative tone when asked about sore throat                               

Grade 2: Moderate - patient complaint of sore throat on his/her own

Grade 3: Severe - patient is in obvious distress

 Post-operative hoarseness of voice was assessed and graded as follows:⁸

Grade 0: No hoarseness of voice anytime since operation

Grade 1: Minimal - Minimum change in quality of speech. Patient answers in affirmative only when enquired about.

Grade 2: Moderate - Moderate change in quality of speech. Patient complains on his/her                      own.

Grade 3: Severe - Gross change in quality of voice. Observer perceives it on his/her own.

All statistical analyses were performed by using SPSS 22.0 software package (SPSS Inc., Chicago, IL, USA). All data were summarized as mean ± SD for continuous variables, numbers and percentages for categorical variables.  The variables were assessed for normality using the Kolmogorov Smirnov test. A p<0.05 was accepted as statistically significant.

TABLE 1: Post operative sore throat at 2hrs

p value =0.01 (S)

At 2 hours, 40 people in the Group A and 34 people in the Group B had sore throat symptoms. Comparison of post-operative sore throat at 2 hours and groups showed statistically significant result with  p value of 0.01 (p< 0.05).

TABLE 2: Post operative sore throat at 6 hrs

p value=0.01 (S)

At 6 hours, 22 people in Group A and 11 people in Group B had sore throat symptoms. Comparison of post-operative sore throat at 6 hours and groups showed statistically significant result with p value of 0.01( p value <0.05)

TABLE-3: Post operative sore throat at 24 hrs

At 24 hours, 4 people in group A had sore throat and none had sore throat symptoms in group B.

TABLE-IV: Post operative sore throat

TABLE-V: Post operative hoarseness of voice at 2 hrs

In our prospective study, we observed that the cases of  post operative hoarseness were 15 in group A and 9 in group B out of total 40 cases in each group at 2 hrs of postoperatively.

TABLE-VI: Post operative hoarseness of voice at 6 hrs

Our prospective study showed that the incidence of hoarseness of voice were 11 in group A and 6 in group B out of 40 cases in each group.

TABLE-VII: Post operative hoarseness of voice at 24 hrs

p value=0.39

Our prospective study showed that the incidence of postoperative hoarseness of voice were 9 in group A and 6 in group B out of 40 cases in each group.

TABLE-VIII: Post operative hoarseness of voice

In our prospective study, we observed that at 2 hours, the incidence of POST was 40 people in the Group A and 34 people in Group B. In Group A, grades 0, 1, 2 and 3 sore throat were seen in 77.5%, 22.5%, 0% and 0% versus 15%, 52.5% 32.5% and 0% in those of Group B. At 2 hours, we observed that the cases of post operative hoarseness were 15 in group A and 9 in group B out of total 40 cases in each group.

Our findings were found in accordance with the study of Singh et al (2019) who included all the patients scheduled to undergo short elective laparoscopic surgeries, lasting < 2hours under general anaesthesia with endotracheal intubation.  The patients were thereby, alloted randomly into two equal groups as follows: Group A having 20 patients who received 200μg budesonide inhalation suspension, using a metered dose inhaler 10 min prior to intubation, which was repeated 6hrs after extubation. Group B had 20 patients with no such interventions performed before intubation or after extubation.  Post-operative sore throat was assessed at 2, 6, 12 and 24 hrs. All the results were categorized and summarized. The results of the study showed that the incidence of POST, cough and hoarseness of voice was significantly higher among the subjects of Group B in comparison to the subjects of Group A at different time intervals (p < 0.05). It was concluded hence, that administration of budesonide by inhalational route significantly reduced the incidence of postoperative cough, hoarseness of voice and POST among subjects undergoing laparoscopic cholecystectomy.³

Our prospective study had the incidence of POST at 6 hours, 22 people in Group A and 11 people in Group B. In Group A, grade 0, 1 of sore throat were seen in 45% and 55% patients. In Group B , grade 0,1 of sore throat were seen in 72% and 27% patients.In our study, the incidence of hoarseness of voice were 11 in group A and 6 in group B out of 40 cases in each group respectively.

Our study results were much comparable with that done by Rajan et al (2018) who did a prospective randomised study where 46 patients undergoing laparoscopic surgeries lasting < 2 hours, were randomly allotted into two equal groups namely A and B. Group A received 200 μg budesonide inhalation suspension, using a metered dose inhaler, 10 min before intubation, and repeated 6 h after extubation whereas no such intervention was performed in Group B. The primary outcome was the incidence and severity of POST. Secondary outcomes included the incidence of post-operative hoarseness and cough. Pearson’s Chi-square test, Fisher’s exact test and Independent sample t-tests were applied as applicable. Results showed that compared to Group B, a significantly fewer number of patients had POST in Group A at 2, 6, 12 and 24 h (p < 0.001). Although more number of patients in Group B had post-operative hoarseness of voice and cough at all time points the difference was statistically significant only at 12 h and 24 h for post-operative hoarseness and at 2 h and 12 h for post-operative cough. The severity as well as the incidence of POST showed a downward trend in both groups over time. By 24 hr no patient in Group A had any complaint of sore throat whereas Group B still had complaint of it. They concluded that inhaled Budesonide suspension is effective in significantly reducing the incidence and severity of POST.²  Findings of our study are in contradiction to the study by Paul et al (2019) where they were using  budesonide and dexamethasone nebulisation in two groups of patients before induction. At 6 hours, they observed that the incidence of post operative sore throat and hoarseness of voice were higher in group of patients having budesonide nebulisation as compared to dexamethasone nebulisation.^11,12

Our prospective study had  the incidence of postoperative sore throat in Group A is 4 out of 40 people  and there were no cases reported in group B respectively.In our study, the incidence of hoarseness of voice were 11 in group A and 6 in group B out of 40 cases in each group.

Our results of the study were in accordance with the study done by Farhang B et al (2018) who conducted a study on 79 patients undergoing low or moderate risk surgeries with endotracheal intubation by randomly assigning them into two groups. One group received zinc lozenges 40 mg and the other group received placebo 30 minutes prior to surgery. The patients were assessed for incidence and severity of sore throat post-operatively at 0, 2, 4 and 24 hours. It was found that there was significantly lower incidence of sore throat in the zinc lozenge group of 7% than the control group (29%) at 4 hours post-operatively (p < 0.046). The incidence of post-operative sore throat was 0% in the zinc lozenge group and 24% in the control group at 0 hour (p < 0.004). The highest incidence of sore throat was seen in the second hour after surgery, 10% in the zinc lozenge group and 34% in the control group (p < 0.0495). At 24 hours post surgery, the incidence of sore throat was 13% in the zinc lozenge group and 24% in the placebo group. The severity of post-operative sore throat was significantly lower in the zinc group for mild (p = 0.003) and moderate (p = 0.004). It was therefore, concluded that administration of a single dose of zinc lozenge (40 mg) 30 minutes pre-operatively is significantly effective in reduction of the incidence and severity of post-operative sore throat.²⁵Our results of study were in contradiction with the study done by Paul et al (2019) where  they observed at 24 hours, the incidence of sore throat and hoarseness of voice were higher in patients using budesonide nebulisation as compared to dexamethasone nebulisation.¹¹ The incidence of post-operative sore throat and hoarseness of voice grades were found significantly higher in the Group A (92% and 37.5%) than in Group B (85% and 22.5%) at 2 hours after extubation of the patients. There were significantly higher grades of POST and hoarseness of voice in Group A than in Group B. The incidence of POST and hoarseness of voice grades were found to be significantly higher in Group A than in Group B (55%, 27.5% versus 27.5%, 15%) at 6 hours post-extubation. Higher grades of all categories were seen in group A. At 24 hours post-extubation, the incidence and grades of POST and hoarseness were found higher in Group A than in Group B (10%,22.5% versus 0%,15%). In Group B, where patients were nebulized with Budesonide is a very safe drug having very rare incidences of side-effects which were mostly self-limiting with discontinuation of use.

Our study that Budesonide is a very safe inhalational corticosteroid that can be used frequently during general anaesthesia using endotracheal tube. It has been found to reduce the incidence and grades of post-operative sore throat, cough and hoarseness of voice in the patients following extubation thereby, enhancing the overall satisfaction of the patients in the post-operative period. Therefore, We recommend use of Budesonide nebulization 30 minutes before intubation and 6 hours after extubating the patients of general anaesthesia.

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