ClinicalTrials.gg
Status unknownNCT05354154InciPostUpdated Apr 29, 2022

Incidence of Postoperative Sore-throat Incidence

An observational study in Sore-throat, sponsored by Rehman Medical Institute - RMI. Status unknown at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-29.

Primary conditionPharyngitis(the registry's first term)UnverifiedIs this wrong?The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Rehman Medical Institute - RMI · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
249
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sore-throat

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03

In context

Pharyngitis Unverified

226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's planned enrollment of 249 is below the median of 289 across 33 observational studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

Rehman Medical Institute - RMI is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Study population is all inpatients admitted in surgical and allied departments.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients having ASA 3 or above physical status
  • Recent or ongoing Upper Respiratory Tract Infection (URTI)
  • Patients going to ICU intubated
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
249 participants (estimated)
Patient registry
No

Interventions

  • Procedureendotracheal intubation

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

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What researchers measure

Primary outcomes

  1. Incidence rate of sorethroat

    Incidence= Those who developed Postoperative sorethroat / All recruited participants who recieve General anesthesia through endotracheal tubes \*100

    Time frame: Six hours

Secondary outcomes

  1. Risk factors assessment

    Associated risk factors for postoperative Sore throat will be assessed for presence or absence through a structured performa

    Time frame: Six hours

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Study locations

1 of 1 sites recruiting
  • Rehman Medical Institute
    Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
    Recruiting
    • Mohammad Shafiq, FCPS · Contactmohammad.shafiq@rmi.edu.pk · +92-91-5838000
    • Rahman U Jan, MCPS · Sub investigator
    • Mohammad Shafiq, FCPS · Principal investigator
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References and documents

Publications

  • 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. PubMed 24843341 ↗
  • 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. PubMed 8431329 ↗
  • 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. PubMed 22127511 ↗
  • 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. PubMed 20078448 ↗
  • 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. PubMed 18310675 ↗
  • 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. PubMed 22999067 ↗
  • 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. PubMed 22174478 ↗
  • 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. PubMed 23248834 ↗
  • 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. PubMed 23225928 ↗
  • 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. PubMed 24263969 ↗
  • 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. PubMed 17000820 ↗
  • 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. PubMed 26470672 ↗
  • 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. PubMed 26171894 ↗
  • 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. PubMed 30617677 ↗
  • 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. PubMed 28173712 ↗
  • 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. PubMed 20870978 ↗

Individual participant data

Plan to share: Yes — Data including clinical and demographic characteristics, not affecting patient's confidentiality, will be shared.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: April, 2022 to April, 2025

Access criteria: IPD will be shared on inter institutional request basis.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05354154
Lead sponsor
Rehman Medical Institute - RMI
Responsible party
Mohammad Shafiq (Principal investigator, Rehman Medical Institute - RMI) — Principal investigator
First posted
Apr 29, 2022
Start date
Apr 1, 2022
Primary completion
Jan 31, 2023 (estimated)
Completion
Mar 31, 2023 (estimated)
Last update
Apr 29, 2022

Study contacts

Mohammad Shafiq, FCPS
Contact
mohammad.shafiq@rmi.edu.pk
+92-91-5838000 ext. 2394
Rahman U Jan, MCPS
Contact
janrahman21@gmail.com
+92-3339749567
Mohammad Shafiq, FCPS
principal investigator · Rehman Medical Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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