European Journal of Cardiovascular Medicine

Spinal anaesthesia has garnered recognition as a safe and 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. Even though it is not a major complication of general anaesthesia and is mostly self-limiting, it affects the patient satisfaction to a very large extent.^1,2

 Multiple factors are known to be involved in the high incidence of complaints of post-operative sore throat, hoarseness of voice and cough like large size of the tracheal tube, design of the cuff, technique of insertion of the tube, trauma from intubation, mucosal dehydration and high intra-cuff pressure. Mucosal friction caused by light plane of anaesthesia leading to patient coughing or bucking, or constant friction between the endotracheal tube and the tracheal mucosa, all culminate upon sore throat and hoarseness of voice post operatively. Cause of prolonged hoarseness of voice is often thought to be arytenoids cartilage dislocation. High intra-cuff pressure of endotracheal tubes has often been associated with nerve palsies due to neurapraxia and compression of nerves which has led to sore throat post extubation.^1,3,5,

Multimodality trials, both pharmacological and non-pharmacological, have been used to reduce the incidence of POST with no proven single modality. Non pharmacological modalities include use of smaller sized endotracheal tubes, careful instrumentation of the airway, minimising attempts of laryngoscopy and intubation, intubation after complete relaxation of the larynx, gentle oropharyngeal suctioning, minimising intra-cuff pressures to less than 20mm Hg and extubation when cuff of the endotracheal tube is fully deflated.

Pharmacological modalities include inhalation of beclomethasone and fluticasone, gargling with azulene sulphonate, aspirin, ketamine, benzydamine hydrochloride, and licorice, administering lozenges of zinc, vitamin C and amyl-m-cresol (Strepsils) and intracuff administration of alkaline lignocaine.⁶

Even though these modalities were effective in curtailing the symptoms, they resulted in development of unwanted adverse effects. Use of ketamine affected haemodynamics and central nervous system of the patient⁷. Gargling as a route of drug administration seemed non-acceptable to a group of patients and not all patients were found compliant to that method of drug delivery. Intracuff lidocaine had increased chances of hoarseness of voice due to diffusing out of the drug from the cuff thereby, leading to nerve paresis and resulting in hoarseness of voice. Higher doses of drugs are required to be used when administered intravenously as compared to topical route of administration, therefore causing more side effects.^2,4

Steroids, known for their anti-inflammatory function, are widely used for this purpose. They inhibit leucocyte migration to the site of inflammation, inhibit cytokine release by maintaining cellular integrity and prevent proliferation of fibroblasts, thereby reducing mucosal inflammation. The inhaled corticosteroids (ICSs), particularly, are widely used for patients at risk of airway diseases since it can be directly delivered to the airways without any systemic exposure or side effects even though total dose administered is minimal. Thus, maximum concentration of the drug remains available at the site of inflammation.²

Budesonide is an inhaled corticosteroid (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 simple and less time-consuming but with high patient acceptability. It would obviate the need of additional equipments like nebulisers or atomisers and reduce the assistance of nursing staff. Side-effects like fluid retention, delayed wound healing and glucose intolerance are comparatively less as compared to intravenous corticosteroids.²

Since post-operative sore throat continues to remain a problem often unaddressed by the clinicians, but culminating into one of the major causes of dissatisfaction among patients post-extubation, this study was performed to assess the effect of inhaled budesonide suspension as prophylactic management of post-operative sore throat following endotracheal intubation.

The present study was conducted in the Department of Anaesthesiology and Critical Care, Pt. B. D. Sharma PGIMS, Rohtak in a prospective, randomised and unblinded manner after obtaining approval from the institutional ethical committee and patients’ written, informed consent. The study included 100 patients of either sex of age 18-60 years, belonging to American Society of Anesthesiologists Physical Status (ASA PS) of I and II with Mallampati Grades (MPG) of 1 and 2, undergoing surgeries under general anaesthesia.

 Patients were randomly allotted to one of the two groups equally, labelled A and B, 50 patients each irrespective of gender, using random number table as follows:

Group A (N=50):              Received 200 mcg Budesonide inhalation suspension 10 min before intubation, which was repeated 6 hours after extubation.

Group B (N=50):              No intervention was performed before intubation or after extubation.

In the operating room, all routine monitors, namely blood pressure cuff, electrocardiogram, pulse-oximeter and capnogram were attached. Peripheral line was secured with 18G cannula and intravenous fluid infusion was started. One puff of the Budesonide metered dose inhaler was given, delivering 200 mcg of the drug 10 minutes before intubation. After preoxygenation with 100% oxygen for 3 min, induction of anaesthesia was done with intravenous glycopyrrolate (0.005 mg kg^-1), fentanyl (2 mcg kg^-1) and thiopentone sodium (5 mg kg^-1). After checking ventilation, intravenous vecuronium (0.08 mg kg^-1) was given. Under direct laryngoscopy, airway was secured by endotracheal tube of appropriate size. Endotracheal tube cuff was filled with appropriate volume of air required for preventing an audible leak. Intra-operatively the cuff pressure was maintained at 20-22 cm of H₂O. The size of endotracheal tube inserted and the number of attempts taken for intubating the patient were noted. Anaesthesia was maintained with 2-3% sevoflurane and 50% N₂O in O₂. Mechanical ventilation was adjusted to maintain end-tidal carbon-dioxide tension at 30-35 mmHg. Supplemental dose of vecuronium was administered as per requirement. Intravenous paracetamol infusion 1 gm was given half an hour before end of surgery. Five minutes before end of surgery, sevoflurane concentration was reduced to 0.8% and thereby, discontinuing it at the end of surgery. The lungs were then ventilated with 100% O₂. Intravenous ondansetron 0.1 mgkg^-1 was given towards the end of surgery. Residual neuro-muscular blockade was reversed by 0.01 mg kg^-1 glycopyrrolate and 0.05 mg kg^-1 neostigmine. The patients were extubated on seeing spontaneous adequate respiratory efforts after proper and gentle oropharyngeal suctioning with a soft suction catheter under vision. Duration of surgery and anaesthesia were noted.

 In the PACU, all the patients were monitored and received inhalational O₂ via venturi mask. Budesonide puff 200 mcg was repeated again 6 hours post-extubation. Post-operative sore throat, hoarseness of voice and cough were assessed at 2 hours, 6 hours, 12 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 cough was assessed and graded as follows:⁸

Grade 0: No cough at any time since operation

Grade 1: Minimal

Grade 2: Moderate

Grade 3: Severe

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. Rescue therapy was considered in the following patients:

• Those who had sore throat, cough or hoarseness of voice anytime post-extubation before beginning of our scheduled observation.
• Those who had Grade 2 and 3 of post-operative sore throat, cough and hoarseness of voice, irrespective of the group they belonged to.

For rescue therapy, we administered normal saline nebulisation, repeated as many times as needed, till there was relief from symptoms.²

Complications of Budesonide and management:

Budesonide is a well-tolerated drug with very rare side-effects during its use. These side-effects are as follows:

• Running nose
• Sneezing and coughing
• Nausea and vomiting
• White patches inside the mouth on long term use
• Bad taste in the mouth
• Allergic reactions

Mostly these side effects are self-limiting and these resolve with time after stopping of the drug.

The data was coded and entered into Microsoft Excel spreadsheet. Analysis was done using SPSS version 20 (IBM SPSS Statistics Inc., Chicago, Illinois, USA) Windows software program. Descriptive statistics included computation of percentages, means and standard deviations. The unpaired t-test (for quantitative data to compare two independent two groups) was used for quantitative data comparison of all clinical indicators. Chi-square test was used for qualitative data whenever two or more than two groups were used to compare. Level of significance was set at p ≤ 0.05.

Patients in both groups were comparable with respect to mean age, gender , ASA grading, MPG, duration of surgery and size of ETT.

                                             Table- I post-operative sore throat grade at 2 hours

p = 0.001 (S)

At 2 hours after extubation, Group A had lesser incidence of post-operative sore throat of 22% in comparison to Group B which had a higher incidence of post-operative sore throat of 48%. It was found statistically significant with p value of 0.001 (p < 0.005).

In Group A, 20% patients had grade 1 post-operative sore throat, 2% had grade 2 and none had grade 3. In Group B, 54% patients had grade 1, 14% patients had grade 2 and 6% patients had grade 3 of post-operative sore throat which was found higher than that in Group A.

TABLE-II Post-operative cough grade at 2 hours

p = 0.001 (S)

After 2 hours of extubation, patients of Group A had lesser incidence of cough of 18% whereas those in Group B had a higher incidence of post-operative cough of 56%. It was found statistically significant with p value of 0.001 (p < 0.05).

In Group A, 16% patients had grade 1, 8% patients had grade 2 and none had grade 3 post-operative cough at 2 hours after extubation. In Group B, 40% patients had grade 1, 16% grade 2 and none had grade 3 post-operative cough at 2 hours after extubation.

TABLE-III Post-operative hoarseness of voice grade at 2 hours

p = 0.001 (S)

The patients in Group A had 22% incidence of post operative hoarseness of voice at 2 hours post extubation whereas in Group B patients had a higher incidence of about 58% hoarseness of voice which was statistically very significant with p value of 0.001 (p < 0.05).

In Group A, grade 1 hoarseness of voice was found in 20% patients, grade 2 in 2% whereas none of the patients had grade 3. In Group B, it was found that the incidence of grade 1 hoarseness of voice was 48%, grade 2 being 10% and none had grade 3.

TABLE-IV Post-operative sore throat grade at 6 hours

p = 0.009 (S)

The incidence of post-operative sore throat at 6 hours was found to be significantly higher in the patients of Group B with incidence of 54% as compared to that found in Group A which was 24%. It was found to be statistically significant with p value 0.009 (p < 0.05).

In the patients of Group A, grade 1 sore throat was found in 20%, grade 2 in 4% and none was found to have grade 3 at 6 hours post extubation. Whereas, in Group B, it was found that 44% had grade 1, 10% had grade 2 and none had grade 3 sore throat at 6 hours after extubation.

TABLE-V Post-operative cough grade at 6 hours

p = 0.08

The patients of Group B are found to have comparable incidence of post-operative cough with that of Group A at 6 hours post extubation. It was not found to be statistically significant since p value was 0.08 (p > 0.05)

The post-operative cough grades at 6 hours post extubation were found comparable between the two groups.

TABLE-VI Post-operative hoarseness of voice grade at 6 hours

p = 0.03 (S)

The incidence of hoarseness of voice at 6 hours post extubation was found to be significantly lower in Group A with incidence of 16% as compared to that in Group B which had incidence of 38%. It was found significant statistically with p value 0.03 (p < 0.05).

Grade 1 hoarseness was found in 14% patients in Group A as compared to 36% patients in Group B. Grade 2 hoarseness was seen equally in both the groups as 2%. None of the groups had grade 3 hoarseness of voice at 6 hours post extubation.

TABLE-VII Post-operative sore throat grade at 12 hours

p = 0.02 (S)

The incidence of post-operative sore throat at 12 hours post extubation was significantly reduced to 10% in Group A as compared to that in Group B with 28% incidence. This was found to be statistically significant with p value of 0.02 (p < 0.02).

At 12 hours post extubation, grade 1 sore throat was seen in only 10% patients of Group A whereas it was 22% in Group B. None of the patients of Group A had grade 2 and grade 3 sore throat whereas 6% patients of Group B had grade 2 and none had grade 3.

TABLE-VIII Post-operative cough grade at 12 hours

p = 0.03 (S)

The incidence of post-operative cough at 12 hours post extubation was seen significantly higher in Group B patients as compared to those in Group A with incidences of 26% and 14% respectively. (p < 0.05)

At 12 hours post extubation, grade 1 cough was exhibited by 8% Group A patients and 24% Group B patients. The patients of Group A didn’t have grade 2 and 3 cough whereas 4% patients of Group B showed grade 2 cough with none of grade 3 from that group.

TABLE-IX Post-operative hoarseness of voice grade at 12 hours

p = 0.04 (S)

At 12 hours post extubation, the incidence of hoarseness of voice was significantly lower in Group A (4%) than that in Group B (16%). It was a statistically significant finding with p value of 0.04 (p < 0.05)

Only 4% of Group A patients had hoarseness of voice at 12 hours after extubation as compared to 16% patients of Group B. Grade 2 and 3 hoarseness was not found in either of the groups.

TABLE-X Post-operative sore throat grade at 24 hours

p = 0.01 (S)

The incidence of post-operative sore throat at 24 hours after extubation was found to be 2% in Group A whereas it was 16% in Group B which was significant statistically having p value of 0.01 (p < 0.05).

Both Groups A and B had only grade 1 sore throat of incidences 2% and 16% respectively. No incidence of grades 2 and 3 sore throat was found in either group.

TABLE-XI Post-operative cough grade at 24 hours

p = 0.03 (S)

There was no incidence of post-operative cough at 24 hours post extubation in Group A whereas 8% incidence of the same was found in Group B which was statistically significant with p value of 0.03 (p < 0.05)

No incidence of cough was seen in Group A. Group B had only 8% incidence of grade 1 cough at 24 hours post extubation with no cough grades 2 and 3.

TABLE-XII Post-operative hoarseness of voice grade at 24 hours

p = 0.04 (S)

There was no incidence of post-operative cough at 24 hours post extubation in Group A whereas 8% incidence of the same was found in Group B which was statistically significant with p value of 0.03 (p < 0.05)

No incidence of cough was seen in Group A. Group B had only 8% incidence of grade 1 cough at 24 hours post extubation with no cough grades 2 and 3.

The present study was aimed at evaluation of the effect of inhaled budesonide suspension on post-operative sore throat, cough and hoarseness of voice after endotracheal intubation.

Post-operative sore throat, hoarseness of voice and cough are quite common but uncomfortable and distressing sequelae subsequent to endotracheal intubation. Though not a typically incapacitating aftermath, it is an extremely unattended and disturbing experience for those who experience this after general anaesthesia accounting for dissatisfaction among patients.There have been multiple studies showing effectiveness of steroids in prevention of POST.^9-13In addition to steroids strepsils and zinc lozenges have also been tried.^14-16.

The mean age of the 100 patients enrolled in our study was found to be 37.45±15.57 kg.Our study had 66 males and 34 females. This difference was due to the different demographic profiles of the patients reporting to the institute. All the patients enrolled in our study were either ASA PS grades I or II. All the patients included in our study were either MPG grade 1 or 2.The mean weight of the 100 patients enrolled in our study was 65.34±8.075. The difference was found statistically significant because of the various demographic profiles of the patients reporting in the institute. In our study we had enrolled patients who underwent surgeries that were of minimum 1 hour and maximum 3 hours duration. We found that in Group A, the mean duration of surgery was 1.86±0.67 hours whereas in our Group B it was comparably 1.91±0.56 hours. 

  All the patients included in our study were assessed for sore throat, cough and hoarseness of voice after extubation at pre-defined time intervals of 2 hours, 6 hours, 12 hours and 24 hours. The presence and severity grades of POST, cough and hoarseness of voice were noted.  

In our prospective study, we observed that at 2 hours after extubation, patients in Group A had lesser incidence of POST (22%) whereas patients in Group B had incidence of 74%. In Group A, grades 1, 2 and 3 sore throat were seen in 20%, 2% and 0% versus 54%, 14% and 6% in those of Group B.

At 2 hours, the incidence of cough in Group A and Group B were found to be 18% and 56% respectively. In Group A, grades 1, 2, 3 cough grades were seen in 16%, 2% and 0% and 40%, 16% and 0% in those of Group B.

The incidence of hoarseness of voice in Group A and Group B were found to be 28% and 40% respectively. In Group A, grades 1, 2 and 3 hoarseness of voice were found in 24%, 2% and 0% and 36%, 4% and 0% in those of Group B.

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, selected 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 showed that the incidence of POST being 12% versus 27% in Groups A and B respectively. The POST grades 1, 2 and 3 in Group A and Group B being 20%, 4% and 0% versus 44%, 10% and 0%.

The incidence of cough in Group A and Group B were 18% and 38% respectively. Grades 1, 2 and 3 cough was found in 16%, 2% and 0% in Group A and 32%, 6% and 0% in Group B.

In our study, the hoarseness of voice was seen in 16% patients of Group A and 38% in Group B. Grades 1. 2 and 3 hoarseness of voice in Group A and B were found to be 14%, 2%, 0% versus 36%, 2% and 0% 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 h no patient in Group A had any complaint of sore throat whereas Group B still had complaint of it. Conclusion therefore being, that inhaled Budesonide suspension is effective insignificantly reducing the incidence and severity of POST.²

In our prospective study, we observed that at 12 hours after extubation, patients in Group A had lesser incidence of POST (10%) whereas patients in Group B had incidence of 28%. In Group A, grades 1, 2 and 3 sore throat were seen in 10%, 0% and 0% versus 22%, 6% and 0% in those of Group B.

At 12 hours, the incidence of cough in Group A and Group B were found to be 8% and 28% respectively. In Group A, grades 1, 2, 3 cough grades were seen in 8%, 0% and 0% and 24%, 4% and 0% in those of Group B.

The incidence of hoarseness of voice in Group A and Group B were found to be 4% and 16% respectively. In Group A, grades 1, 2 and 3 hoarseness of voice were found in 4%, 0% and 0% and 16%, 0% and 0% in those of Group B.

Borazan et al (2012) conducted a study in 70 patients undergoing orthopaedic surgery by randomly allocating them into two groups, one received placebo (control) and the other received magnesium lozenges, to be dissolved by sucking 30 minutes pre-operatively. The patients were assessed for incidence and severity of post-operative sore throat at 0, 2, 4 and 24 hours. It was found from the study that the incidence of POST at 4 hours was higher in the control group than in the magnesium group (95% CI 0.26, p = 0.032). The highest incidence of POST occurred at the second hour after surgery with 23% incidence in the magnesium group and 57% incidence in the control group (95% CI 0.34, p = 0.007). The severity of POST at 0 and 2 hours were significantly lower in the magnesium group, p < 0.007 and p < 0.002 respectively. Hence, it was concluded that administration of magnesium lozenge 30 minutes prior to surgery is effective in reduction of both incidence and severity of post-operative sore throat.¹⁸ Our study results reciprocated well with this study done by Borazan et al. 

Our prospective study showed that the incidence of POST being 2% versus 16% in Groups A and B respectively. The POST grades 1, 2 and 3 in Group A and Group B being 8%, 0% and 0% versus 16%, 0% and 0%.

The incidence of cough in Group A and Group B were 0% and 8% respectively. Grades 1, 2 and 3 cough was found in 0%, 0% and 0% in Group A and 8%, 0% and 0% in Group B.

In our study, the hoarseness of voice was seen in 0% patients of Group A and 8% in Group B. Grades 1. 2 and 3 hoarseness of voice in Group A and B were found to be 0%, 0%, 0% versus 8%, 0% and 0% respectively.

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.¹⁶

Patients in both groups were comparable with respect to mean age, gender , ASA grading, MPG, duration of surgery and size of ETT. The incidence of post-operative sore throat, cough and hoarseness of voice grades were found significantly higher in the Group B than in Group A at 2 hours after extubation of the patients (74%, 56% and 40% versus 22%, 18% and 28%). There were significantly higher grades of POST, cough and hoarseness of voice in Group B than in Group A. The incidence of POST and hoarseness of voice grades were found to be significantly higher in Group B than in Group A (27%, 38% versus 12%, 16%) at 6 hours post-extubation. Though the incidence of cough was higher in Group b than in Group A, it was not statistically significant. Higher grades of all three categories were seen in Group B.

In Group B higher incidence of POST, cough and hoarseness of voice were seen as compared to Group A (28%, 28%, 18% versus 10%, 8%, 4%) at 12 hours post-extubation. There were higher grades of POST, cough and hoarseness of voice in Group B.

At 24 hours post-extubation, the incidence and grades of POST, cough and hoarseness were found higher in Group B than in Group A (16%, 8%, 8% versus 2%, 0%, 0%).

In Group A, where patients were given Budesonide puff before intubation and after extubation, the incidence of POST, cough and hoarseness of voice gradually decreased over time after extubation.

Budesonide is a very safe drug having very rare incidences of side-effects which were mostly self-limiting with discontinuation of use.

 we concluded from 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.

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