Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

Study Overview
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Brief Summary
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Rationale: Delivery dry gas during anesthesia is associated with post-operative sore throat (POST). Oxygen nebulizer therapy increases humidity to the airway, especially post-extubation. Objective: To investigate the effect and complications of oxygen nebulizer therapy on POST.

Official Title
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Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Other: Oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years Pre-operative Hb >10 g% or Hct > 30% American Society of Anesthesiologist (ASA) class I-III Elective surgery General anesthesia with oroendotracheal tube using Macintosh laryngoscope Not exposed to intraoperative nitrous oxide Oxygen saturation at room air > 95% before induction and at arrival the PACU Exclusion Criteria: Cases needing ICU admission immediately post-operative Conditioning requiring post-operative oxygen therapy e.g. heart disease, pregnancy, morbid obesity, cardiac and thoracic surgery Patients' conditioning affecting to complication of nebulizer oxygen therapy e.g. pulmonary disease, bleomycin treatment Patient's conditioning affecting POST assessment e.g. pre-operative using ventilator, recent upper respiratory tract infection (URI), recent lower respiratory tract infection and history of difficult airway Surgical conditioning affecting POST e.g. airway surgery, oral surgery, esophageal and neck surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No oxygen<br>No given oxygen at post-anesthetic care unit | |
| Active Comparator: Oxygen<br>Oxygen nebulizer via face mask, Fraction of inspired oxygen (FiO2) 0.4, flow 8 liter per minute (LPM) for 30 minutes | Other: Oxygen<br>* Oxygen mask 40% 8 LPM for 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of oxygen nebulizer therapy on post-operative sore throat | Assess POST using scoring system and discomfort by interview. Sore throat scoring system is divided into 4 scores 0 means no sore throat means minimal sore throat (less severe than cold) means moderate sore throat (similar to cold) means severe sore throat (more severe than cold) | at post-anesthetic care unit and 24-h post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the adverse events (pulmonary complications, wound infection, and mortality) of post-operative complications related to oxygen therapy |  | 24-h post-op and 30-d mortality | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nebulizer, oxygen, post-operative sore throat