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Sore-throatInciPostNCT05354154

Incidence of Postoperative Sore-throat Incidence

An observational study of Sore-throat, run by Rehman Medical Institute - RMI at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Sore-throat
What is being tested?
endotracheal intubation
Type of treatment
Surgery or procedure
How many people
249 participants
Where
1 sitePakistan
Study dates
1 Apr 2022to 31 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mohammad Shafiq, FCPS contact

+92-91-5838000 ext. 2394

mohammad.shafiq@rmi.edu.pk

Rahman U Jan, MCPS contact

+92-3339749567

janrahman21@gmail.com

Pakistan1 site, 1 recruiting

  • Rehman Medical Institute

    Peshawar, Khyber Pakhtunkhwa, 25000

    Mohammad Shafiq, FCPS, +92-91-5838000 ext. 2394, mohammad.shafiq@rmi.edu.pk

    Rahman U Jan, MCPS

    Recruiting

Other trials in Pakistan

About this study

Official title: Incidence of Postoperative Sore Throat and Risks Analysis in Patients Undergoing General Anesthesia With Endotracheal Intubation: A Prospective Cross-sectional Study

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.

Conditions
Sore-throat
Being tested
endotracheal intubation
Medical subject headings
Pharyngitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endotracheal intubationProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of sorethroat

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

    Measured: Six hours

Secondary outcomes (1)

  1. Risk factors assessment

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

    Measured: Six hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start1 Apr 2022
  3. Primary completion31 Jan 2023 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
249 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05354154
Sponsor's protocol ID
RMI/RMI-REC/Approval/126
Acronym
InciPost
Status last verified
Apr 2022
First submitted
25 Apr 2022
Last updated
29 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data including clinical and demographic characteristics, not affecting patient's confidentiality, will be shared.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Sore-throat, run by Rehman Medical Institute - RMI at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohammad Shafiq, FCPS (+92-91-5838000 ext. 2394, mohammad.shafiq@rmi.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of sorethroat (time frame: Six hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05354154, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.

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