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Completed

NCT Number: NCT05834179

Effect of Colding of Endotracheal Tubes on Sore Throat

Postoperative sore throat (POST) is a common and undesirable postoperative symptom that causes patient dissatisfaction. Cold application is a non-invasive, non-pharmacological, cost-effective and effort-effective therapy for pain management. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University

Adana, Turkey (Türkiye)

About this study

The incidence of postoperative sore throat (POST) has been reported up to 62% following general anaesthesia.It is an undesirable events experienced by patients after general anaesthesia. Various pharmacological agents have been applied to reduce POST, such as lidocaine, ketamine, magnesium, corticosteroids or non-steroidal anti-inflammatory drugs. However, these agents may have some systemic and local side effects. Therefore, various non-pharmacological applications have been investigated to reduce sore throat. Cold application is a non-invasive, cost-effective and effort-effective therapy for pain management. Although the mechanism is not clearly known, it increases the pain threshold, slows cellular metabolism, causes vasoconstriction, and reduces capillary permeability. Therefore, we hypothesized that colding of endotracheal tube may decrease POST associated with airway inflammation. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation. The goal of this study is to identify a simple, safe, and inexpensive perioperative intervention to reduce post operative sore throat. This study is a prospective, randomised study involving 116 subjects and they will assessed on the incidence and severity of sore throat, dysphagia and dysphonia at 1. 4. 12. 24. hours after removal of endotracheal tube. Outcomes from this study can be extended to patients who will be receiving general anaesthesia using a endotracheal tube to reduce the incidence and severity of sore throat.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who were entubated with an ETT. Those who accept the research Elective surgery Patients in American Society of Anaesthesiologists (ASA) I and II class 18 years and over Mallampati classification I and II Operation time more than 1 hour

Exclusion criteria

Patients with sore throat and lower respiratory tract infection Patients with a history of allergies

Treatment and study plan

cold endotracheal tube

Other

patients who were intubated with an ETT which kept in the fridge.

Primary outcomes

  1. the incidence of sore throat 1 hour after extubation.

    Time frame: 1 hour after extubation

    Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)

Secondary outcomes

  1. the severity of sore throat 1 hour after extubation.

    Time frame: 1 hour after extubation

    Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe

  2. the incidence of sore throat 4 hour after extubation.

    Time frame: 4 hour after extubation

    Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)

  3. the severity of sore throat 4 hour after extubation.

    Time frame: 4 hour after extubation

    Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe

  4. the incidence of sore throat 12 hour after extubation.

    Time frame: 12 hour after extubation

    Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)

  5. the severity of sore throat 12 hour after extubation.

    Time frame: 12 hour after extubation

    Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe

  6. the incidence of sore throat 24 hour after extubation.

    Time frame: 24 hour after extubation

    Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)

  7. the severity of sore throat 24 hour after extubation.

    Time frame: 24 hour after extubation

    Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe

  8. the incidence of dysphonia

    Time frame: 1 hour after extubation

    Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)

  9. the incidence of dysphonia

    Time frame: 4 hour after extubation

    Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)

  10. the incidence of dysphonia

    Time frame: 12 hour after extubation

    Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)

  11. the incidence of dysphonia

    Time frame: 24 hour after extubation

    Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)

  12. the incidence of dysphagia

    Time frame: 12 hour after extubation

    Presence of dysphagia defined as difficulty or pain provoked by swallowing

  13. the incidence of dysphagia

    Time frame: 24 hour after extubation

    Presence of dysphagia defined as difficulty or pain provoked by swallowing

  14. the incidence of postoperative respiratory infection

    Time frame: 7 days after operation

    Presence of respiratory infection symptoms such as cough, sputum, rhinorrhea, sore tongue, myalgia or fever

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

Effect of Colding of Endotracheal Tubes on Postoperative Sore Throat: A Prospective Randomized Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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