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Incidence of Postoperative Sore-throat Incidence

NCT ID: NCT05354154

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Sore-throat

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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endotracheal intubation

Consenting healthy patients of either sex will be endotracheally intubated under controlled environment

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rehman Medical Institute - RMI

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Shafiq

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad Shafiq, FCPS

Role: PRINCIPAL_INVESTIGATOR

Rehman Medical Institute

Locations

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Rehman Medical Institute

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Mohammad Shafiq, FCPS

Role: CONTACT

Phone: +92-91-5838000

Email: [email protected]

Rahman U Jan, MCPS

Role: CONTACT

Phone: +92-3339749567

Email: [email protected]

Facility Contacts

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Mohammad Shafiq, FCPS

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 24843341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8431329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22127511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20078448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18310675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22999067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22174478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23248834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23225928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24263969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17000820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26470672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26171894 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30617677 (View on PubMed)

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.

Reference Type RESULT
PMID: 28173712 (View on PubMed)

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.

Reference Type RESULT
PMID: 20870978 (View on PubMed)

Other Identifiers

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RMI/RMI-REC/Approval/126

Identifier Type: -

Identifier Source: org_study_id