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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02492646
Other study ID # JHSeo_Saline
Secondary ID
Status Completed
Phase N/A
First received July 1, 2015
Last updated June 1, 2017
Start date August 2015
Est. completion date January 2017

Study information

Verified date June 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the influence of none-lubricated dry tube on the incidence of Postoperative Sore Throat (POST) after general anesthesia with endotracheal intubation.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation

Exclusion Criteria:

- history of gastroesophageal reflux disease (GERD)

- congenital or acquired abnormalities of the upper airway such as tumor, polyp, trauma, abscess, inflammation, infection, or foreign bodies

- previous airway surgery; increased risk of aspiration

- coagulation disorders

- previous history of difficult intubation or conditions with expected difficult airway including Mallampati classification = 3 or thyromental distance < 6.5 cm

- Using the other intubation devices beyond the direct laryngoscopy such as lighted stylet or fiberoptic bronchoscopy

- symptoms of sore throat or upper respiratory tract infection

- expected to place nasogastric tube during perioperative period

- requiring nasotracheal intubation

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Saline group
After anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation.
Dry group
After anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of postoperative sore throat (POST) ask patients whether they have sore throat after surgery until one day after surgery
Secondary Oropharyngeal injury assessed by direct visualization of the oropharyngeal cavity with regard to the location such as pharyngeal wall, uvula, vallecular, tonsillar fossa and pillars and presence of hyperemia, edema, hematoma, or any other lesions 2 hours and 24 hours after surgery
Secondary respiratory symptoms At the 1 week postoperative follow-up phone call, patients would be asked if they have upper respiratory symptoms such as cough, sputum, sore throat or fever. And if so, they would be checked if they diagnosed following diseases, common cold, tonsillitis, pneumonia or any other possible respiratory infectious diseases. 1 week after the surgery
Secondary severity of postoperative sore throat (POST) The severity of POST was evaluated on a 4-point-scale : 0, no sore throat; 1, mild sore throat (complained of sore throat only upon inquiry); 2, moderate sore throat (complained of sore throat on his/her own); 3, severe sore throat (change of voice or hoarseness, associated with throat pain) When arriving at postanesthesia care unit (PACU) and thereafter 2, 4, and 24 hours after the surgery
See also
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Not yet recruiting NCT03792776 - Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough N/A
Completed NCT04371094 - Sore Throat After Intubation Using Glidescope With Stylet and Bougie N/A
Enrolling by invitation NCT04644900 - Effect of Chewing Gum and Mouthwash Before Operation on Sore Throat After General Anesthesia With a Laryngeal Mask N/A
Active, not recruiting NCT06122324 - Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat
Recruiting NCT05825872 - Ultrasound-Guided Internal Superior Laryngeal Nerve Block for Double-Lumen Bronchial Tube Phase 4
Not yet recruiting NCT06368843 - the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat