Effect of Saline Lubrication on Post-intubation Complications

Seoul National University Hospital300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

300

Conditions

Postoperative Sore Throat

Interventions

Saline groupPROCEDURE

After anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation.

Dry groupPROCEDURE

After anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

incidence of postoperative sore throat (POST)

ask patients whether they have sore throat after surgery

Time frame: until one day after surgery

Secondary Outcomes

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

Time frame: 2 hours and 24 hours after surgery

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.

Time frame: 1 week after the surgery

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)

Time frame: When arriving at postanesthesia care unit (PACU) and thereafter 2, 4, and 24 hours after the surgery

Data from ClinicalTrials.gov

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