Topical dexamethasone versus topical 10%lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study

doi:10.21203/rs.3.rs-4973804/v1

Background

Postoperative sore throat is one of the most common postoperative complaints and can decrease patient satisfaction. The current study aimed to evaluate the effects of topical dexamethasone compared to 10% lidocaine spray in reducing post-intubation sore throats in patients undergoing shoulder arthroscopic surgeries.

Methods

In this study, 100 patients scheduled for shoulder arthroscopy under general anesthesia were intubated and randomly allocated into two groups. For the first group, an endotracheal tube was soaked in 8 mg of dexamethasone before intubation, while for the second group, the tube was sprayed with 10% lidocaine. The severity of sore throat in both groups was evaluated at 1 hour and 6 hours after extubation.

Result

The study compared the post-operative sore throat levels between the dexamethasone and lidocaine groups, each with 50 participants. There were no significant differences in demographics or operation duration between the groups. One hour post-operation, the dexamethasone group reported significantly less sore throat, with lower mean (0.72 ± 0.83) and median (0.5, IQR 0.0–1.0) sore throat scores compared to the lidocaine group (mean: 1.48 ± 0.84; median: 2.0, IQR 1.0–2.0). Similarly, six hours post-operation, the dexamethasone group continued to report significantly lower sore throat levels (mean: 0.42 ± 0.61; median: 0.0, IQR 0.0–1.0) than the lidocaine group (mean: 0.72 ± 0.76; median: 1.0, IQR 0.0–1.0).

Conclusion

Topical dexamethasone was more effective than lidocaine in reducing postoperative sore throat.

Trial registration

Clinical trials number NO. NCT06266481 Date 04/01/2024 ({1}) ({1})(https//clinicaltrials.gov/study/NCT06266481)

Topical dexamethasone

lidocaine spray

postoperative sore throat

shoulder arthroscopy

A common adverse effect of general anesthesia is a sore throat, which is experienced by 62% of patients following tracheal intubation.[1] It has been found that the tracheal mucosa releases inflammatory mediators following intubation, indicating that an inflammatory process is most likely the cause of postoperative sore throat (POST).[2, 3]

With differing degrees of effectiveness, several non-pharmacological and pharmacological techniques have been investigated to reduce POST. Use of a smaller endotracheal tube (ETT), the application of water-soluble gel to the ETT, caution during airway instrumentation, waiting until complete relaxation before intubation, gentle oropharyngeal suction, lowering intra-cuff pressure, minimizing cuff inflation, and fully deflating the tracheal tube are examples of non-pharmacological techniques. Pharmacological interventions have also been demonstrated to reduce the occurrence of POST, including the use of lignocaine, steroids, non-steroidal anti-inflammatory medications, and azulene sulfonic acid gargling, liqurioce, magnesium and ketamine.[4–6]

Previous research indicates that the administration of dexamethasone through various methods, such as intravenous, nebulization, or topical, can effectively reduce the occurrence of POST.[5, 7]

According to other research, local and systemic lidocaine therapy appears to reduce the incidence of postoperative sore throats following surgery.[8, 9]

The goal of this study was to compare topical dexamethasone and topical lidocaine spray as a result of their ability to prevent sore throats that develop after shoulder arthroscopic procedures.

Following approval from the local ethics committee (PUA04202312313157) and registration of the study at ClinicalTrials.gov (NCT06266481), written informed consent was obtained from all participants after explaining the study procedures. The study, conducted from January to July 2024, focused on patients aged 18 to 50 years with an ASA physical status classification of I or II scheduled for elective shoulder arthroscopic surgery. Exclusions included individuals unwilling to consent, those with anticipated difficult airways, allergies to steroids or lidocaine, ASA classifications III or IV, uncontrolled diabetes, current steroid use, gastroesophageal reflux disease (GERD), pregnancy, and preexisting upper respiratory conditions, end-stage renal failure, or liver failure.

The research involved 100 patients who were randomly allocated into two groups. In the dexamethasone group (Group A), intubation was performed using an endotracheal tube whose cuff had been soaked in 8 mg of dexamethasone for 10 minutes prior to the procedure.[10] In contrast, the lidocaine group (Group B) was intubated with an endotracheal tube that had been sprayed with 10% lidocaine.[11]

Preoperative assessments for all patients included medical history, demographic data, physical examination, and airway assessment. Anesthesia induction was achieved with propofol (2 mg/kg), cis-atracurium (0.2 mg/kg), and fentanyl (2 mcg/kg IV). For male patients, a 7.5 mm internal diameter pretreated tube with a high-volume/low-pressure cuff was used, while female patients were intubated with a 7.0 mm internal diameter pretreated tube according to group. Anesthesia was maintained using isoflurane (1.2–1.5 vol%), 50% O2 with air, and cisatracurium (0.03 mg/kg IV every hour). After surgery, only oral suction was performed, and endotracheal suction was avoided. Neostigmine 0.04mg/kg (2.5 mg) with atropine 0.4mg atropine per 1mg neostigmine (1 mg) was administered to reverse neuromuscular blockade, and extubation was carried out smoothly once the patient regained consciousness.[12, 13]

Patients were assessed at 1 hour and 6 hours after extubation for post-operative sore throat (POST). The severity of POST was measured using a modified 4-point scale: 0 = no sore throat, 1 = mild sore throat (complaints only when asked), 2 = moderate sore throat (spontaneous complaints), and 3 = severe sore throat (voice changes or hoarseness).[14]

Sample size:

The sample size was calculated using G Power 3.1.9.7, 2020, (t test).[15] Based on mean of sore throat severity among patients treated with similar topical corticosteroids after 24 hours of 0.1 ± 0.2, mean of sore throat severity among patients with topical lidocaine after 24 hours of 0.4 ± 0.2 [11, 16] giving an effect size of 0.6, alpha error of 0.05, power of 80%, the minimum required sample size was calculated to be 90 participants. The sample will be rounded to 100 patients (50 intubated with a dexamethasone-soaked tube and 50 intubated with a tube sprayed with 10% lidocaine).

Statistical analysis:

The collected data was wrangled, coded, and analyzed using the SPSS software (Armonk, NY: IBM Corp). The quantitative variables were expressed using mean ± SD whereas the categorical variables expressed by counts (%). A chi-square test was used to estimate the difference between the categorical variables; and whenever it was not valid, monte carlo exact probability was used. Independent t test was used to estimate the relation between continuous variables. Statistical significance was considered when p<0.05.

A total of 110 patients were evaluated for eligibility, of which 10 were excluded due to difficult intubation or receiving dexamethasone IV. 100 patients were enrolled in the study and allocated into two group of 50 patients in each group, as shown in the study flow chart.(figure 1)patients demographic data and Duration of operation (Minutes) were comparable between the groups with insignificant differences.(table 1)

Table 1: Comparison of the studied groups as regard sociodemographic characteristics & duration of operation

	Dexamethasone group (n= 50)	Lidocaine group (n= 50)	Test of significance (p)
Age (Years)	30.28 ± 5.58	31.94 ± 8.9	t= -1.112, p= 0.269
Height (Cm)	161.2 ± 4.5	162.3 ± 4.6	t= -1.2, p= 0.22
Weight (kg)	80.0 ± 11.2	76.6 ± 9.66	t= 1.64, p= 0.1
Duration of operation (Minutes)	108.0 ± 13.5	105.9 ± 14.0	t= 0.76, p= 0.44
Sex			X²= 0.04, p= 0.84
Male	27 (54%)	26 (52%)
Female	23 (46%)	24 (48%)

Data was described by Mean ± SD,Sex described by N (%)

t; Independent t test

X2; Chi square Test

The study also assessed the degree of pain one hour post-operation in the dexamethasone and lidocaine groups. In the dexamethasone group, 50% of participants reported no pain, compared to 16% in the lidocaine group. Mild pain was reported by 30% of the dexamethasone group and 26% of the lidocaine group. Moderate pain was experienced by 18% of the dexamethasone group, whereas 52% of the lidocaine group reported moderate pain. Severe pain was reported by 2% of participants in the dexamethasone group and 6% in the lidocaine group. The mean pain score was significantly lower in the dexamethasone group (0.72 ± 0.83) compared to the lidocaine group (1.48 ± 0.84). The median pain score was also lower in the dexamethasone group (0.5, IQR 0.0 – 1.0) compared to the lidocaine group (2.0, IQR 1.0 – 2.0), with these differences being statistically significant. ( table 2,figure 2,4)

Table (2): Comparison in both groups as regards Pain degree (1hrs)

	Dexamethasone group (No.=50)		Lidocaine group (No.=50)		*Test of significant* *(p)*
	*No.*	%	*No.*	%	*Test of significant* *(p)*
No	25_a	50.0	8_b	16.0	*^MCp<0.001
Mild	15_a	30.0	13_a	26.0
Moderate	9_a	18.0	26_b	52.0
Severe	1_a	2.0	3_a	6.0
Mean ± SD	0.72 ± 0.83		1.48 ± 0.84		t= -4.543, p<0.001*
Median (IQR)	0.5 (0.0 – 1.0)		2.0 (1.0 – 2.0)		t= -4.543, p<0.001*

^MCp; Monte Carlo Exact probability

*;Statistically significant (p<0.05)

_{a, b};Different letters indicates significant difference between column proportion

The study further compared the degree of pain six hours post-operation between the dexamethasone and lidocaine groups. In the dexamethasone group, 64% of participants reported no pain, compared to 44% in the lidocaine group. Mild pain was experienced by 30% of the dexamethasone group and 42% of the lidocaine group. Moderate pain was reported by 6% of the dexamethasone group, whereas 12% of the lidocaine group experienced moderate pain. Only 2% of participants in the lidocaine group reported severe pain, while no severe pain was reported in the dexamethasone group. The mean pain score was significantly lower in the dexamethasone group (0.42 ± 0.61) compared to the lidocaine group (0.72 ± 0.76). The median pain score was also lower in the dexamethasone group (0.0, IQR 0.0 – 1.0) compared to the lidocaine group (1.0, IQR 0.0 – 1.0), with these differences being statistically significant. (table 3,figure 3,4)

Table (3): Comparison in both groups as regards Pain degree (6hrs)

	Dexamethasone group (N= 50)		Lidocaine group (N= 50)		*Test of significant* *(p)*
	*No.*	%	*No.*	%	*Test of significant* *(p)*
No	32	64.0	22	44.0	^MCp= 0.145
Mild	15	30.0	21	42.0
Moderate	3	6.0	6	12.0
Severe	0	0	1	2.0
Mean ± SD	0.42 ± 0.61		0.72 ± 0.76		t= -2.183, p= 0.031*
Median (IQR)	0.0 (0.0 – 1.0)		1.0 (0.0 – 1.0)		t= -2.183, p= 0.031*

^MCp; Monte Carlo test

The findings of this study demonstrate a significant advantage of topical dexamethasone over lidocaine spray in managing postoperative sore throat both one hour and six hours after surgery. The results suggest that dexamethasone provides superior relief, contributing to better patient comfort and potentially enhancing postoperative recovery.

Dexamethasone showed better sore throat control with 50% reporting no sore throat compared to 16% in the lidocaine group. Moderate sore throat was more common in the lidocaine group (52% vs. 18%). Severe sore throat was slightly higher in lidocaine (6% vs. 2%). Mean sore throat scores were lower in the dexamethasone group (0.72 ± 0.83 vs. 1.48 ± 0.84). At six hours, dexamethasone continued to outperform lidocaine with fewer reports of sore throat across all severities.

The severe sore throat observed in our study may be explained by findings from the research titled "Effect on Postoperative Sore Throat of Spraying the Endotracheal Tube Cuff with Benzydamine Hydrochloride, 10% Lidocaine, and 2% Lidocaine." In this study, the authors, including first author Hung, Nan-Kai MD, reported that the use of 10% lidocaine on the endotracheal tube (ETT) cuff resulted in an increased severity of postoperative sore throat (POST) compared to 2% lidocaine or placebo. The 10% lidocaine solution contains additives such as menthol and ethanol, which may irritate the tracheal mucosa, potentially contributing to the heightened discomfort experienced by patients.[17]

Dexamethasone is effective in reducing postoperative sore throat due to its corticosteroid properties, which generally work by reducing edema. This is accomplished by inhibiting leukocyte emigration and plasma component migration, which prevents excessive cellular swelling by enhancing the stability of cellular membranes. ^[18] Additionally, corticosteroids such as dexamethasone reduce hydrolysis near cells, prevent the release of lysozymes from granulocytes and phagocytes, and inhibit fibrosis by suppressing fibroblast proliferation.[19]

The corticosteroid binds to annexin proteins, leading to the production of Ca2+-dependent phospholipids, which inhibit phospholipase A2 and reduce the synthesis of inflammatory mediators, such as prostaglandins and leukotrienes.[20] This Furthermore, topical corticosteroid oral rinses can be used to treat oral mucosal diseases and are effective in relieving oral symptoms in patients with chronic graft-versus-host disease following bone marrow transplantation.[21]

The precise anti-inflammatory mechanism of lidocaine remains unclear, but it is thought to affect several inflammatory processes, such as phagocytosis, migration, exocytosis, and cellular metabolism. In vitro studies involving human polymorphonuclear granulocytes suggest that lidocaine may inhibit membrane ion transporters, which could disrupt cellular pH levels and, consequently, reduce cytokine release.[22]

The study by Lee et al. (2017) in the Korean Journal of Anesthesiology agrees with the current study, showing that topical dexamethasone effectively reduces postoperative sore throat. In a study of 90 patients undergoing laparoscopic cholecystectomy, Researchers evaluated three groups: one with normal saline gargling and tube soaking (Group C), another with dexamethasone solution gargling and normal saline tube soaking (Group G), and the third with normal saline gargling and dexamethasone tube soaking (Group S). The findings revealed that the dexamethasone-soaked tube group (Group S) experienced a significantly lower incidence and severity of postoperative sore throat (POST) compared to Group C. Their conclusion was that the use of dexamethasone, either as a gargle or for tube soaking, is effective in reducing the incidence and severity of postoperative sore throat.[16]

While the study by Jabbar et al. evaluated the efficacy of topical dexamethasone emollient, glycerin emollient and lidocaine gel in mitigating postoperative complications such as laryngospasm, hoarseness, and sore throat, it found no significant differences among the groups in terms of these outcomes. However, it did identify lidocaine gel as effective in reducing the incidence of postoperative sore throat. This finding contrasts with our study, which suggests that these differences may be attributed to the use of dexamethasone emollient and lidocaine gel in their study, whereas we used lidocaine spray and dexamethasone solution.[23]

The findings of Singh et al. align with our study, which compares dexamethasone, lidocaine, magnesium, benzydamine, ketamine, water-based lubricant, and liquorice for preventing postoperative sore throat after tracheal intubation. Their meta-analysis, based on 70 RCTs with 7,141 patients, found that magnesium, liquorice, corticosteroids, benzydamine, ketamine, and water-based lubricant were among the most effective interventions, while topical lidocaine was found to be the least effective. This supports our observations on the varying efficacy of dexamethasone versus lidocaine.[6]

Reducing postoperative sore throat (POST) after surgery significantly enhances patient comfort and satisfaction, leading to a smoother recovery and potentially faster discharge. It also lowers the risk of complications related to coughing or throat irritation, reduces the need for additional pain medications, and contributes to better overall patient outcomes. This improvement in patient experience can streamline clinical workflows and reduce healthcare costs by minimizing the need for follow-up care and additional interventions.[24]

Future Research and Limitations

Despite these findings, this study has several limitations. First, the plasma concentrations of dexamethasone and lidocaine were not measured. Additionally, the study did not assess potential side effects or complications associated with each treatment, such as coughing or bucking during extubation or hoarseness of voice post extubation.

Future studies should focus on overcoming these limitations by incorporating larger and more diverse populations and evaluating the outcomes of postoperative sore throat management with dexamethasone and lidocaine. It would also be valuable to compare these treatments with other topical drugs.

In conclusion, this study provides compelling evidence that dexamethasone is more effective than lidocaine in managing postoperative sore throat both one hour and six hours after surgery. The significant reduction in sore throat scores and the lower incidence of moderate and severe sore throat highlight the potential of dexamethasone to improve postoperative recovery and patient outcomes. Further research is warranted to confirm these findings and explore the broader applications and safety of dexamethasone in sore throat management.

POST

postoperative sore throat

ETT

endotracheal tube

ASA

American society of anesthesia.

Ethics approval and consent to participate: After getting approval from the local ethics committee (PUA04202312313157) and registering the study at ClinicalTrials.gov (NCT06266481) Date 04/01/2024, we made sure to get written informed consent from all participants. We explained the study procedures to them before they agreed to participate.

Consent for publication: All authors have reviewed the final manuscript and provided their consent for publication in BMC Anesthesiology. Additionally, all participants involved in the study provided informed consent for the publication of anonymized data derived from their involvement in the research.

Availability of data and materials: the numerical data from the study is available from the authors upon request.

Competing interests: The authors declare that they have no competing interests.

Funding: None

Authors' contributions

MEM: study design, data collection, manuscript writing, analysis

HAA: study design, manuscript writing, review

AFH: study design, manuscript writing, review

Acknowledgements: We extend our sincere thanks to the patients and staff at pharos university for their participation and support in this study. We also appreciate the assistance provided by the nursing and anesthesiology teams during the research. We are particularly grateful for the valuable feedback from our colleagues and mentors, including Professor Ahmed Fouad Hussein Salem, Professor Hatem Amin Attallah whose guidance and insights greatly contributed to the success of this work.

El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016;71(6):706–17. https://doi.org/10.1111/anae.13438.
Mathew G, Agha R, Albrecht J, Goel P, Mukherjee I, Pai P, et al. STROCSS 2021: Strengthening the reporting of cohort, cross-sectional and case-control studies in surgery. Int J Surg. 2021;96:106165. https://doi.org/10.1016/j.ijsu.2021.106165.
Lee JY, Sim WS, Kim ES, Lee SM, Kim DK, Na YR, et al. Incidence and risk factors of postoperative sore throat after endotracheal intubation in Korean patients. J Int Med Res. 2017;45(2):744–52. https://doi.org/10.1177/0300060516687227.
Cirilla DJ, Ngo J, Vaisman V, Daly C, Ata A, Sandison M, et al. Does the incidence of sore throat postoperatively increase with the use of a traditional intubation blade or the GlideScope? J Clin Anesth. 2015;27(8):646–51. https://doi.org/10.1016/j.jclinane.2015.06.005.
Gemechu BM, Gebremedhn EG, Melkie TB. Risk factors for postoperative throat pain after general anaesthesia with endotracheal intubation at the University of Gondar Teaching Hospital, Northwest Ethiopia, 2014. Pan Afr Med J. 2017;27:127. https://doi.org/10.11604/pamj.2017.27.127.10566.
Singh NP, Makkar JK, Cappellani RB, Sinha A, Lakshminarasimhachar A, Singh PM. Efficacy of topical agents for prevention of postoperative sore throat after single lumen tracheal intubation: a Bayesian network meta-analysis. Can J Anaesth. 2020;67(11):1624–42. .https://doi.org/10.1007/s12630-020-01792-4.
Ki S, Myoung I, Cheong S, Lim S, Cho K, Kim MH, et al. Effect of dexamethasone gargle, intravenous dexamethasone, and their combination on postoperative sore throat: a randomized controlled trial. Anesth Pain Med (Seoul). 2020;15(4):441–50. https://doi.org/10.17085/apm.20057.
Mekhemar NA, El-Agwany AS, Radi WK, El-Hady SM. Comparative study between benzydamine hydrochloride gel, lidocaine 5% gel and lidocaine 10% spray on endotracheal tube cuff as regards postoperative sore throat. Braz J Anesthesiol. 2016;66(3):242–8. .https://doi.org/10.1016/j.bjane.2014.09.007.
Kuriyama A, Maeda H. Topical application of licorice for prevention of postoperative sore throat in adults: A systematic review and meta-analysis. J Clin Anesth. 2019;54:25–32. https://doi.org/10.1016/j.jclinane.2018.10.025.
Sharma S, Bhardwaj V, Sharma S, Rana S. Dexamethasone to decrease post-anesthesia sore throat (POST) and hoarseness-which is the most effective route: intravenous, topical, or nebulization? A prospective randomized trial. Ain-Shams J Anesthesiol. 2021;13(1):26. https://doi.org/10.1186/s42077-021-00144-8.
Banihashem N, Alijanpour E, Hasannasab B, Zarei A. Prophylactic Effects of Lidocaine or Beclomethasone Spray on Post-Operative Sore Throat and Cough after Orotracheal Intubation. Iran J Otorhinolaryngol. 2015;27(80):179–84.
Drugs.com. Nimbex Dosage. 2024. https://www.drugs.com/dosage/nimbex.html. Accessed 2 Aug, 2024].
Butterworth JF, Mackey DC, Wasnick JD. Morgan and Mikhail's Clinical Anesthesiology. 7th ed. New York: McGraw Hill; 2022.
Canbay O, Celebi N, Sahin A, Celiker V, Ozgen S, Aypar U. Ketamine gargle for attenuating postoperative sore throat. Br J Anaesth. 2008;100(4):490–3. .https://doi.org/10.1093/bja/aen023.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91. https://doi.org/10.3758/bf03193146.
Lee JH, Kim SB, Lee W, Ki S, Kim MH, Cho K, et al. Effects of topical dexamethasone in postoperative sore throat. Korean J Anesthesiol. 2017;70(1):58–63. https://doi.org/10.4097/kjae.2017.70.1.58.
Hung NK, Wu CT, Chan SM, Lu CH, Huang YS, Yeh CC, et al. Effect on postoperative sore throat of spraying the endotracheal tube cuff with benzydamine hydrochloride, 10% lidocaine, and 2% lidocaine. Anesth Analg. 2010;111(4):882–6. .https://doi.org/10.1213/ANE.0b013e3181d4854e.
Streeten DH. Corticosteroid therapy. I. Pharmacological properties and principles of corticosteroid use. JAMA. 1975;232(9):944. 7.https://doi.org/10.1001/jama.232.9.944.
González-Moles MA, Scully C. Vesiculo-erosive oral mucosal disease–management with topical corticosteroids: (1) Fundamental principles and specific agents available. J Dent Res. 2005;84(4):294–301. https://doi.org/10.1177/154405910508400401.
Yao XL, Cowan MJ, Gladwin MT, Lawrence MM, Angus CW, Shelhamer JH. Dexamethasone alters arachidonate release from human epithelial cells by induction of p11 protein synthesis and inhibition of phospholipase A2 activity. J Biol Chem. 1999;274(24):17202–8. .https://doi.org/10.1074/jbc.274.24.17202.
Park AR, La HO, Cho BS, Kim SJ, Lee BK, Rhie JY, et al. Comparison of budesonide and dexamethasone for local treatment of oral chronic graft-versus-host disease. Am J Health Syst Pharm. 2013;70(16):1383–91. .https://doi.org/10.2146/ajhp120567.
Ali ZA, El-Mallakh RS. Nebulized Lidocaine in COVID-19, An Hypothesis. Med Hypotheses. 2020. 144:109947.https://doi.org/10.1016/j.mehy.2020.109947.
Jabbar ML, Mahboba JH, Meazher N. Comparing the effectiveness of topical dexamethasone emollient, lidocaine gel, and glycerin emollient on the endotracheal tube for postoperative hoarseness of voice, sore throat, and laryngospasm. J Med Life. 2023;16(6):904–7. .https://doi.org/10.25122/jml-2022-0137.
Yang N, Tao Q, Niu J, Yu J. Postoperative Sore Throat After General Anesthesia: A Narrative Review. J Anesht Transl Med. 2023;2:34. https://doi.org/10.58888/2957-3912-2023-03-05.

No competing interests reported.

Topical dexamethasone versus topical 10%lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study

Status:

Version 1

Abstract

Background

Methods

Result

Conclusion

Trial registration

Figures

Introduction

Patients And Methods

Discussion

Future Research and Limitations

Conclusion

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1