Controlled comparison between siccoral spraying, stomatovis gargle or strefen tablets to reduce postoperative sore throat in patients undergoing elective genitourinary surgery under general anesthesia with orotracheal intubation

Tracheal intubation is a foremost cause of trauma to the airway mucosa, resulting in postoperative sore throat which is common, uncomfortable, distressing sequelae with reported incidence of 21-65%. Although it is a minor complication it was rated by the patients as the 8th most undesirable outcome in the postoperative period. Stomatovis mouthwash is usefull for the protection of oral mucosa, prevention of symptoms associated with stomatitis of various origins and gingivitis. It also helps lubrication and moisture of the oral cavity. Strefen, a sugar-based lozenge formulation that contains the nonsteroidal anti-inflammatory drug flurbiprofen was developed to provide soothing topical effects in addition to the pain relief conferred by the systemic analgesic drug also can be administered for sore throat. Siccoral is long acting mouth and throat moisturizer contaning sea salt and glycerine. It moisturize mouth and throat mucous by its osmotic effect, provides sliminess in mouth like saliva, prevents risk of irritation and infections due to dryness. The aim of this study is to compare the effectiveness of these drugs in alleviating postoperative sore throat (POST) using different approaches: spraying into the oral cavity, gargling or perioperative administration of lozenges. The study is approved by the institutional ethics commitee and performed at Diskapi Yildirim Beyazit Education and Research Hospital. 320 patients of either sex aged between 18 to 80 ASA I-III, elective patients undergoing genitouriner surgery under general anesthesia with orotracheal intubation will be recruited in the study. The study is conducted in a prospective randomized, controlled and single blinded manner. Patients with a history of preoperative sore throat and asthma, Mallampati grade >2, known allergies to study drug, recent NSAID medication, surgical duration of >240 min, use of nasogastric tube, patients with upper respiratory track infection, patients on steroid therapy and those who requires more than one attempt at intubation will be excluded from the study. It will take 2 months to complete this study. - Strefen group(STR): Flurbiprofen 8.75 mg. Sucrose, Glucose Syrup, Honey, Macrogol 300, Lemon Flavour, Potassium Hydroxide, Levomenthol. Reckitt Benckiser Healthcare, UK; strefen pastil will be applied 45 minutes before induction of anesthesia. - Siccoral group(SCR): 10 mg sea salt % 1, glyserol, patent blue, methyl paraben, prophyl paraben, purified water. Drossapharm,Basel, Switzerland; siccoral will be sprayed into the oropharyngeal cavity 4 puffs, 1minute before induction of anesthesia. -Stomatovis group(STM): Purified water, xylitol, marshmallow mucilage, vegetable glycerol, dipotassium glycyrrhizinate, phosphoglucan, carboximethyl beta-glucan, sodium bicarbonate, chlorobutanol, PVM/MA, sodium hydroxymethyl glycinate, PEG-40 hydrogenated castor oil , acesulfame K, flavouring, green color (E102, E131, E514).Roma,Italy: stomatovis 15-20 ml will be gargled by the patient for at least 60 seconds before induction of anesthesia. -Control group(C): control group. Tracheal intubation will be performed by an experienced anaesthesiologist who wis blinded to group allocation after ensuring maximum neuromuscular blocking effect as assessed by TOF guard. A train of four<10% is used as an indication of satisfactory neuromuscular blocakade for intubation. All patients will receive i.v. acetaminofen 1000 gr 30 minutes after tracheal intubation. Postoperative sore throat will be evaluated by the anesthetist in charge of the post-anesthesia care unit, blinded to the group allocations within 20 minutes in the recovery room(0 hour)and 1,6,24 hour after surgery. At the time of the first evaluation, patients with a Ramsey Sedation Score* of 2 (cooperative, oriented and tranquil) or 3 ( responding to commonds only) will be included. The severity of postoperative sore throat (POST) is graded on a four point scale as follows: 0, no sore throat;1, mild sore throat(complains of sore throat only on asking);2, moderate sore throat(complains of sore throat on his own);3, severe sore throat(change of voice associated with throat pain