Clinical trial NCT05354154: Incidence of Postoperative Sore-throat Incidence
Official title: Incidence of Postoperative Sore Throat and Risks Analysis in Patients Undergoing General Anesthesia With Endotracheal Intubation: A Prospective Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sore-throat
Lead sponsor: Rehman Medical Institute - RMI
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population is all inpatients admitted in surgical and allied departments.

Brief summary: Postoperative sore throat is a distressing but frequent symptom presented by the patients on the floor upon awakening from General Anesthesia, where endotracheal intubation is part of the Anesthetic protocol. Its incidence ranges between 21-71.8%. Good skills and availability of trained staff to cause minimal tissue damage are expected to reduce the incidence. Risks factors associated will be analyzed.

Detailed description: Post-operative sore throat (POST) is a common complication of endotracheal intubation. It ranges from 21 to 71.8 %. Various factors contribute to the development of POST, like, female sex, smoking, intubation difficulty and Suxamethonium use, high endotracheal cuff pressure, airway suctioning, long duration of surgery, mucosal injury with laryngoscopy, or pharyngeal airway use and larger size endotracheal tubes \[9\]. POST has also been associated with laryngeal masks, injury with laryngoscopy, or pharyngeal airway use and larger size endotracheal tubes. Basically it is mucosal damage of the throat and trachea which releases inflammatory mediators and produces soreness. POST leads to postoperative dissatisfaction. Patients of POST are uncontended following general anesthesia. Its preemptive amelioration, has been studied using various pharmacological interventions. The list includes, but is not limited to, Benzydamine hydrochloride (BH), aspirin, ketamine, lidocaine and dexamethasone. There is limited evidence based literature available about the incidence of POST in the investigator's locality in the country. The investigators plan to collect data in General OT of Rehman Medical institute (RMI), Peshawar. The city of Peshawar is the largest city of Khyber Pakhtunkhwa, a province of Pakistan, having a population of approximately 2 million. The objectives of our study is to know the magnitude of the problem and ascertain factors associated with postoperative sore throat among patients undergoing elective surgery under general anesthesia with endotracheal intubation.

Eligibility criteria: Inclusion Criteria:

* Any patient of either gender aged 18- 60 years
* Patients of American Society of Anesthesiologists (ASA) physical status 1 and 2 receiving General Anesthesia with ETT

Exclusion Criteria:

* Patients having ASA 3 or above physical status
* Recent or ongoing Upper Respiratory Tract Infection (URTI)
* Patients going to ICU intubated

Primary outcomes:
measure: Incidence rate of sorethroat
timeFrame: Six hours
Secondary outcomes:
measure: Risk factors assessment
timeFrame: Six hours
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Rehman Medical Institute
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Rehman Medical Institute
name: Mohammad Shafiq, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gupta D, Agrawal S, Sharma JP. Evaluation of preoperative Strepsils lozenges on incidence of postextubation cough and sore throat in smokers undergoing anesthesia with endotracheal intubation. Saudi J Anaesth. 2014 Apr;8(2):244-8. doi: 10.4103/1658-354X.130737.
citation: Alcock R, Peachey T, Lynch M, McEwan T. Comparison of alfentanil with suxamethonium in facilitating nasotracheal intubation in day-case anaesthesia. Br J Anaesth. 1993 Jan;70(1):34-7. doi: 10.1093/bja/70.1.34.
citation: Joe HB, Kim DH, Chae YJ, Kim JY, Kang M, Park KS. The effect of cuff pressure on postoperative sore throat after Cobra perilaryngeal airway. J Anesth. 2012 Apr;26(2):225-9. doi: 10.1007/s00540-011-1293-2. Epub 2011 Nov 30.
citation: Mencke T, Noeldge-Schomburg G. Laryngeal morbidity after use of the laryngeal mask airway. Acta Anaesthesiol Scand. 2010 Feb;54(2):127-8. doi: 10.1111/j.1399-6576.2009.02159.x. No abstract available.
citation: Canbay O, Celebi N, Sahin A, Celiker V, Ozgen S, Aypar U. Ketamine gargle for attenuating postoperative sore throat. Br J Anaesth. 2008 Apr;100(4):490-3. doi: 10.1093/bja/aen023. Epub 2008 Mar 1.
citation: Xu YJ, Wang SL, Ren Y, Zhu Y, Tan ZM. A smaller endotracheal tube combined with intravenous lidocaine decreases post-operative sore throat - a randomized controlled trial. Acta Anaesthesiol Scand. 2012 Nov;56(10):1314-20. doi: 10.1111/j.1399-6576.2012.02768.x. Epub 2012 Sep 24.
citation: Patki A. Laryngeal mask airway vs the endotracheal tube in paediatric airway management: A meta-analysis of prospective randomised controlled trials. Indian J Anaesth. 2011 Sep;55(5):537-41. doi: 10.4103/0019-5049.89900.
citation: Jaensson M, Gupta A, Nilsson UG. Risk factors for development of postoperative sore throat and hoarseness after endotracheal intubation in women: a secondary analysis. AANA J. 2012 Aug;80(4 Suppl):S67-73.
citation: Bagchi D, Mandal MC, Das S, Sahoo T, Basu SR, Sarkar S. Efficacy of intravenous dexamethasone to reduce incidence of postoperative sore throat: A prospective randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2012 Oct;28(4):477-80. doi: 10.4103/0970-9185.101920.
citation: Chen CY, Kuo CJ, Lee YW, Lam F, Tam KW. Benzydamine hydrochloride on postoperative sore throat: a meta-analysis of randomized controlled trials. Can J Anaesth. 2014 Mar;61(3):220-8. doi: 10.1007/s12630-013-0080-y. Epub 2013 Nov 22.
citation: 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 Oct;103(4):1001-3. doi: 10.1213/01.ane.0000231637.28427.00.
citation: Mayhood J, Cress K. Effectiveness of ketamine gargle in reducing postoperative sore throat in patients undergoing airway instrumentation: a systematic review. JBI Database System Rev Implement Rep. 2015 Sep;13(9):244-78. doi: 10.11124/jbisrir-2015-2045.
citation: Tanaka Y, Nakayama T, Nishimori M, Tsujimura Y, Kawaguchi M, Sato Y. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD004081. doi: 10.1002/14651858.CD004081.pub3.
citation: Kuriyama A, Maeda H. Preoperative intravenous dexamethasone prevents tracheal intubation-related sore throat in adult surgical patients: a systematic review and meta-analysis. Can J Anaesth. 2019 May;66(5):562-575. doi: 10.1007/s12630-018-01288-2. Epub 2019 Jan 7.
citation: Lee JY, Sim WS, Kim ES, Lee SM, Kim DK, Na YR, Park D, Park HJ. Incidence and risk factors of postoperative sore throat after endotracheal intubation in Korean patients. J Int Med Res. 2017 Apr;45(2):744-752. doi: 10.1177/0300060516687227. Epub 2017 Feb 7.
citation: Scuderi PE. Postoperative sore throat: more answers than questions. Anesth Analg. 2010 Oct;111(4):831-2. doi: 10.1213/ANE.0b013e3181ee85c7. No abstract available.