|Year : 2016 | Volume
| Issue : 1 | Page : 61-65
Comparative study to analyze the incidence of sore throat, cough, and hoarseness of voice after general anesthesia with the use of topical benzydamine hydrochloride and 2% lignocaine gel with placebo
Vangipuram Raghava Chari, Arnab Paul
Department of Anesthesiology and Critical Care, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Dr. D. Y. Patil Vidyapeeth, Pune, Maharashtra, India
|Date of Web Publication||22-Dec-2015|
Department of Anaesthesiology and Critical Care, Dr. D. Y. Patil Medical College, Pimpri, Pune, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Postoperative sore throat (POST) is the most common airway-related complaint of patients after endotracheal intubation. Postextubation coughing during emergence from general anesthesia (GA) is an important problem. Objectives: To compare the effects of topical benzydamine hydrochloride and 2% lignocaine on reducing the incidence and severity of POST, hoarseness, and coughing after general endotracheal anesthesia. Materials and Methods: Patients were randomly allocated into three groups of 30 patients each. In Group B (topical benzydamine hydrochloride), Group L (2% lignocaine gel), Group N (normal saline) was applied to the cuffed endotracheal tube (ETT) before intubation. Results: The trend of the severity of sore throat, hoarseness of voice, and cough during the first 24 h after the GA in benzydamine recipients was significantly lower than the other two groups (P < 0.05). Conclusions: It was observed that the incidence of POST, hoarseness of voice, and cough was significantly less when cuff of ETT was lubricated with topical benzydamine hydrochloride as compared with 2% lignocaine gel.
Keywords: 2% lignocaine gel, hoarseness of voice, sore throat, topical benzydamine
|How to cite this article:|
Chari VR, Paul A. Comparative study to analyze the incidence of sore throat, cough, and hoarseness of voice after general anesthesia with the use of topical benzydamine hydrochloride and 2% lignocaine gel with placebo. Med J DY Patil Univ 2016;9:61-5
|How to cite this URL:|
Chari VR, Paul A. Comparative study to analyze the incidence of sore throat, cough, and hoarseness of voice after general anesthesia with the use of topical benzydamine hydrochloride and 2% lignocaine gel with placebo. Med J DY Patil Univ [serial online] 2016 [cited 2020 Sep 18];9:61-5. Available from: http://www.mjdrdypu.org/text.asp?2016/9/1/61/167972
| Introduction|| |
Postoperative sore throat (POST) occurs in up to 90% of intubated patients ,,,, and is the most common airway-related complaint of patients after endotracheal intubation.  Many contributing factors have been studied, including the material and design of the endotracheal tube (ETT), lubricants on the tube, the equipment utilized for intubation and airway management, the relaxant or anesthetics administered, hypotension, trauma at laryngoscopy or intubation, and the experience of the practitioner. ,,, Intracuff pressure on ETT is also an important cause of POST and hoarseness of voice.  In addition, either the tracheal tube itself or the laryngoscopy per se can cause laryngeal trauma and sore throat. 
Postextubation coughing during emergence from general anesthesia (GA) and later in the postanesthesia care unit (PACU) is an important problem, with an incidence of 15-94% that can result in potentially dangerous complications such as hypertension, cardiac dysrhythmias, myocardial ischemia, surgical bleeding, bronchospasm, raised intraocular, and intracranial pressure. 
Many agents have been used as lubricant to reduce the incidence of POST with variable efficacy. , We conducted a study to compare the incidence of POST with topical benzydamine hydrochloride and 2% lignocaine gel with placebo as a lubricant for ETT insertion in patients undergoing GA for elective surgery.
Benzydamine hydrochloride is a topical nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, antipyretic, and local anesthetic activities.  It is produced initially by the Angelini laboratories in 1960s. Subsequently, topical productions have been advertised globally for the symptomatic healing of oropharyngeal disorders.  It is a prostaglandin synthetase inhibitor and is normally free of adverse systemic effects. Unlike other NSAIDs, it does not inhibit cyclooxygenase or lipoxygenase and is not ulcerogenic. 
Lignocaine, an amide local anesthetic, is commonly administered topically or intravenously to attenuate the reflexes associated with intubation, as well as to decrease the incidence and severity of POST. Several in vitro studies have studied the diffusion of intra-cuff lignocaine and have suggested the use of the ETT cuff as a lignocaine reservoir. ,,
| Materials and Methods|| |
After obtaining ethical clearance from our Institute's Ethical Committee and informed written patient consent, 90 adults (18-60 years) of both sexes, ASA physical status I-II, nonsmoker, and undergoing elective surgery in supine position under GA were enrolled in this prospective, randomized, double-blind study. Patients were equally divided into three groups. Patients with a history of preoperative sore throat, more than one attempt at intubation, Mallampati grade >2, known allergies to lignocaine or benzydamine hydrochloride, patients with recent NSAID medication, oropharyngeal surgery, nasogastric tube insertion, throat packing, and depolarizing muscle relaxant were excluded from the study.
Preanesthetic check-up was done 1-day prior to the surgery. Patients were advised overnight fasting. After shifting the patient to the operating room, intravenous access was obtained and crystalloids connected. Patients were monitored for electrocardiography (ECG), noninvasive blood pressure (NIBP), and SpO 2 . The patient was then premedicated with injection glycopyrrolate (0.2 mg), injection ondansetron (4 mg), injection midazolam (1 mg), and injection fentanyl (2 μg/kg) intravenously. Patients in Group B (n = 30) had 2.5 ml of topical benzydamine hydrochloride gel applied on the cuff of ETT. Patients in Group L (n = 30) had 2.5 ml of 2% lignocaine gel applied on the cuff of ETT. Patients in Group N (n = 30) had 2.5 ml of normal saline applied on the cuff of ETT. The patient was induced with injection propofol (2 mg/kg) intravenously. Tracheal intubation was facilitated by vecuronium bromide 0.1 mg/kg, and the trachea was intubated with a soft seal cuffed sterile polyvinyl chloride ETT of appropriate size. The cuff was inflated with gas mixture (50% N 2 O in oxygen) to maintain stable cuff pressure, and cuff pressure was maintained between 20 and 30 cm of water with the use of a pressure monitoring transducer. Laryngoscopy and endotracheal intubation were performed by the senior resident who was blinded to the group allocation and anesthesia was maintained on O 2 (50%), N 2 O (50%), and isoflurane on intermittent positive pressure ventilation with Bain's circuit. Monitoring consisted of 5-lead ECG, NIBP, pulse oximetry, nasopharyngeal temperature, and EtCO 2, which was kept between 30 and 35 mm Hg. At the end of the surgery, the muscle relaxation was reversed by a combination of neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg. After gentle suctioning of oral secretions by a 12F suction catheter, patients were extubated and transferred to the PACU. At arrival of patients in the PACU, sore throat will be measured by a blinded nurse or an anesthesia postgraduate student at 1, 6, 12, and 24 h with Visual Analog Scale (VAS) [Table 1] between 0 and 3 for sore throat, cough and hoarseness and binary scale (yes/no) regarding various relevant adverse effects. Patients with VAS of 2 or more were given nebulized saline for 20 min and reassessed.
Binary scale (yes/no) - For burning sensation in throat, irritation in throat, altered sensation or local numbness, and bucking and coughing.
Demographic values, cuff pressures, and operation times were assessed with one-way ANOVA test, and sore throat and side effects were assessed with χ2 test. The level of significance is 95% that is P < 0.05 was considered as statistically significant.
| Results|| |
This study was performed on 90 patients who underwent elective surgery under GA and were allocated to three groups randomly (30 patients in each group) [Figure 1] [Figure 2] [Figure 3].
|Figure 1: Comparison of sore throat. After 24 h, there was no sore throat noted in patients with benzydamine group. B: Topical benzydamine hydrochloride group, L: 2% lignocaine gel group, N: Normal saline group|
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|Figure 2: Comparison of hoarseness of voice. After 24 h there was no hoarseness of voice noted in patients with benzydamine group. B: Topical benzydamine hydrochloride group, L: 2% lignocaine gel group, N: Normal saline group|
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|Figure 3: Comparison of cough. After 24 h there was no cough noted in the patients with benzydamine group. B: Topical benzydamine hydrochloride group, L: 2% lignocaine gel group, N: Normal saline group|
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| Discussion|| |
Apart from injury to the teeth, the most common complications of endotracheal intubation are POST and postoperative hoarseness (PH). ,, The incidence of POST and PH varies in different studies depending on the population under survey. In one previous study, the incidence of POST and PH was found to be 40% and 42%, respectively in a female population.  These symptoms are so common that the patients and the anesthesia staff believe that they are a natural consequence of endotracheal intubation.  POST is at its peak in the early postoperative period 2-6 h after extubation but the incidence decreases rapidly with time. , It can sometimes be long-lasting, and after 96 h, it has been reported that as many as 11% can have residual symptoms.  The symptoms of POST or PH are sometimes disturbing, and they are one of several outcome variables associated with patient dissatisfaction. ,,,
This study was designed to compare the local effects of lignocaine and topical benzydamine hydrochloride with placebo in preventing POST, cough, and hoarseness.
Sore throat, cough, and hoarseness following endotracheal intubation remain a problem for many patients after surgery. Although a minor complication, it contributes to postoperative morbidity and patient dissatisfaction. 
Brimacombe et al. explained that pressure exerted by the tracheal tube cuff on the mucosa may exceed capillary perfusion pressures and is a major cause of morbidity in intubated patients.  Jensen et al. found that frequency and severity of POST after short-term intubation was significantly greater after the use of low-pressure, high-volume cuffs, than after the use of a mask or of high-pressure, low-volume cuffs.  The incidence of sore throat varies with the use of different lubricants, degree of intra-cuff pressures, and number of attempts of airway device insertion. 
McHardy and Chung in a review about POST commented that lubricants containing local anesthetics do not appear to be beneficial but may actually be harmful.  Two percent lignocaine jelly has also been implicated as a cause of transient bilateral recurrent laryngeal nerve palsy.  In a study comparing saline and lignocaine gel for occurrence of POST with classic laryngeal mask airway, the incidence of sore throat was found to be similar with both and author suggested that there is no role of lignocaine gel in prevention of POST.  However, Tanaka et al. in a data-based systematic review concluded that topical and systemic lignocaine is useful for prevention of POST. 
The efficacy of strepsil tablets, inhaled fluticasone propionate and benzydamine hydrochloride spraying on ETT cuff in reducing POST, has also been evaluated recently. ,,,
In a study, in 2006, it was proved that benzydamine could reduce POST within the first 24 h after surgery. 
The role of intracuff pressure in causing POST has been studied by some investigators who found that a significant increase in cuff pressure is seen during first 60 min.  Tracheal mucosal lesions seen by endoscopy were more common when the cuff was inflated with air instead of a N 2 O/oxygen mixture. , So, we used 50% nitrous oxide in oxygen. However, we checked intra-cuff pressure several times during surgery and kept it at 25 cm of H 2 O.
The incidence of sore throat in the lignocaine group is low when compared with the study done by Soltani and Aghadavoudi where they evaluated the efficacy of various ways of lignocaine application in reducing POST and cough. This difference could be attributed to subjective feeling and size of the study group. They also explained that postoperative cough is due to irritation of respiratory mucosa by ETT. It seems reasonable, therefore, to consider targeted application of local anesthesia to the mucosa in contact with the ETT as a method of increasing ETT tolerance. They evaluated the number of coughs per patients and found that the frequency of cough in the recovery room was 64.4% in lignocaine group. 
| Conclusions|| |
The pain scale after surgery was reduced using both lignocaine and benzydamine, but the benzydamine effect was more noticeable. It was observed that the incidence of POST, hoarseness of voice, and cough was significantly less when cuff of ETT was lubricated with topical benzydamine hydrochloride as compared with lignocaine gel.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Loeser EA, Kaminsky A, Diaz A, Stanley TH, Pace NL. The influence of endotracheal tube cuff design and cuff lubrication on postoperative sore throat. Anesthesiology 1983;58:376-9.
Loeser EA, Orr DL 2 nd
, Bennett GM, Stanley TH. Endotracheal tube cuff design and postoperative sore throat. Anesthesiology 1976;45:684-7.
Loeser EA, Stanley TH, Jordan W, Machin R. Postoperative sore throat: Influence of tracheal tube lubrication versus cuff design. Can Anaesth Soc J 1980;27:156-8.
Stock MC, Downs JB. Lubrication of tracheal tubes to prevent sore throat from intubation. Anesthesiology 1982;57:418-20.
Hartsell CJ, Stephen CR. Incidence of sore throat following endotracheal intubation. Can Anaesth Soc J 1964;11:307-12.
Stehling LC. Management of the airway. In: Barash PG, Cullen BF, Stoelting RK, editors. Clinical Anesthesia. Philadelphia: JB Lippincott; 1992. p. 685-708.
Suzuki N, Kooguchi K, Mizobe T, Hirose M, Takano Y, Tanaka Y. Postoperative hoarseness and sore throat after tracheal intubation: Effect of a low intracuff pressure of endotracheal tube and the usefulness of cuff pressure indicator. Masui 1999;48:1091-5.
Soltani HA, Aghadavoudi O. The effect of different lidocaine application methods on postoperative cough and sore throat. J Clin Anesth 2002;14:15-8.
Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth 1994;73:786-7.
McHardy FE, Chung F. Postoperative sore throat: Cause, prevention and treatment. Anaesthesia 1999;54:444-53.
Turnbull RS. Benzydamine hydrochloride (Tantum) in the management of oral inflammatory conditions. J Can Dent Assoc 1995;61:127-34.
Mahon WA, De Gregorio M. Benzydamine: A critical review of clinical data. Int J Tissue React 1985;7:229-35.
Anand JS, Glebocka ML, Korolkiewicz RP. Recreational abuse with benzydamine hydrochloride (tantum rosa). Clin Toxicol (Phila) 2007;45:198-9.
Sconzo JM, Moscicki JC, DiFazio CA. In vitro
diffusion of lidocaine across endotracheal tube cuffs. Reg Anesth 1990;15:37-40.
Matias E, Steen SN. Diffusion of lidocaine across the cuffs of endotracheal tubes [abstract]. Anesth Analg 1994;78:S270.
Verbanck L, Van Aken H. The cuff of the endotracheal tube: A depot for the diffusion of lidocaine [abstract]. Anesth Analg 1993;76:S444.
Biro P, Seifert B, Pasch T. Complaints of sore throat after tracheal intubation: A prospective evaluation. Eur J Anaesthesiol 2005;22:307-11.
Chen KT, Tzeng JI, Lu CL, Liu KS, Chen YW, Hsu CS, et al.
Risk factors associated with postoperative sore throat after tracheal intubation: An evaluation in the postanesthetic recovery room. Acta Anaesthesiol Taiwan 2004;42:3-8.
Mencke T, Echternach M, Kleinschmidt S, Lux P, Barth V, Plinkert PK, et al.
Laryngeal morbidity and quality of tracheal intubation: A randomized controlled trial. Anesthesiology 2003;98:1049-56.
Jaensson M, Olowsson LL, Nilsson U. Endotracheal tube size and sore throat following surgery: A randomized-controlled study. Acta Anaesthesiol Scand 2010;54:147-53.
Beebe DS. Complications of tracheal intubation. Semin Anesth Perioper Med Pain 2001;20:166-72.
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;111:882-6.
Jenkins K, Grady D, Wong J, Correa R, Armanious S, Chung F. Post-operative recovery: Day surgery patients' preferences. Br J Anaesth 2001;86:272-4.
Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg 1999;89:652-8.
Philip BK. Patients' assessment of ambulatory anesthesia and surgery. J Clin Anesth 1992;4:355-8.
Agarwal A, Nath SS, Goswami D, Gupta D, Dhiraaj S, Singh PK. An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: A prospective, randomized, single-blind study. Anesth Analg 2006;103:1001-3.
Brimacombe J, Keller C, Giampalmo M, Sparr HJ, Berry A. Direct measurement of mucosal pressures exerted by cuff and non-cuff portions of tracheal tubes with different cuff volumes and head and neck positions. Br J Anaesth 1999;82:708-11.
Jensen PJ, Hommelgaard P, Søndergaard P, Eriksen S. Sore throat after operation: Influence of tracheal intubation, intracuff pressure and type of cuff. Br J Anaesth 1982;54:453-7.
Figueredo E, Martínez M, Pintanel T. A comparison of the ProSeal laryngeal mask and the laryngeal tube in spontaneously breathing anesthetized patients. Anesth Analg 2003;96:600-5.
Inomata S, Nishikawa T, Suga A, Yamashita S. Transient bilateral vocal cord paralysis after insertion of a laryngeal mask airway. Anesthesiology 1995;82:787-8.
Keller C, Sparr HJ, Brimacombe JR. Laryngeal mask lubrication. A comparative study of saline versus 2% lignocaine gel with cuff pressure control. Anaesthesia 1997;52:592-7.
Tanaka Y, Nakayama T, Nishimori M, Sato Y, Furuya H. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev 2009 Jul 8;(3):CD004081.
Ebneshahidi A, Mohseni M. Strepsils® tablets reduce sore throat and hoarseness after tracheal intubation. Anesth Analg 2010;111:892-4.
Tazeh-Kand NF, Eslami B, Mohammadian K. Inhaled fluticasone propionate reduces postoperative sore throat, cough, and hoarseness. Anesth Analg 2010;111:895-8.
Huang YS, Hung NK, Lee MS, Kuo CP, Yu JC, Huang GS, et al.
The effectiveness of benzydamine hydrochloride spraying on the endotracheal tube cuff or oral mucosa for postoperative sore throat. Anesth Analg 2010;111:887-91.
Burgard G, Möllhoff T, Prien T. The effect of laryngeal mask cuff pressure on postoperative sore throat incidence. J Clin Anesth 1996;8:198-201.
Bernhard WN, Yost LC, Turndorf H, Cottrell JE, Paegle RD. Physical characteristics of and rates of nitrous oxide diffusion into tracheal tube cuffs. Anesthesiology 1978;48:413-7.
Stanley TH, Kawamura R, Graves C. Effects of nitrous oxide on volume and pressure of endotracheal tube cuffs. Anesthesiology 1974;41:256-62.
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