An interventional study of cold endotracheal tube in Postoperative Sore Throat, sponsored by Baskent University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Baskent University · Not applicable, Interventional, and Prevention
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.
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.
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's enrollment of 116 is below the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →Baskent University is the lead sponsor of 209 studies on the registry; 35 are open to participants now.
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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
Patients who were intubated with an ETT which kept in the fridge.
Other: cold endotracheal tube
Patients who were intubated with an ETT which kept in the operation room.
patients who were intubated with an ETT which kept in the fridge.
the incidence of sore throat 1 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Time frame: 1 hour after extubation
the severity of sore throat 1 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Time frame: 1 hour after extubation
the incidence of sore throat 4 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Time frame: 4 hour after extubation
the severity of sore throat 4 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Time frame: 4 hour after extubation
the incidence of sore throat 12 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Time frame: 12 hour after extubation
the severity of sore throat 12 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Time frame: 12 hour after extubation
the incidence of sore throat 24 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Time frame: 24 hour after extubation
the severity of sore throat 24 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Time frame: 24 hour after extubation
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Time frame: 1 hour after extubation
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Time frame: 4 hour after extubation
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Time frame: 12 hour after extubation
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Time frame: 24 hour after extubation
the incidence of dysphagia
Presence of dysphagia defined as difficulty or pain provoked by swallowing
Time frame: 12 hour after extubation
the incidence of dysphagia
Presence of dysphagia defined as difficulty or pain provoked by swallowing
Time frame: 24 hour after extubation
the incidence of postoperative respiratory infection
Presence of respiratory infection symptoms such as cough, sputum, rhinorrhea, sore tongue, myalgia or fever
Time frame: 7 days after operation
Plan to share: No
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