Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Other: Oxygen

• Registration Number: NCT01763177
• Lead Sponsor: Prince of Songkla University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-08
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-15
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1036

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygen	Oxygen	Oxygen nebulizer via face mask, Fraction of inspired oxygen (FiO2) 0.4, flow 8 liter per minute (LPM) for 30 minutes

Primary Outcome Measures

Name	Time	Method
The effect of oxygen nebulizer therapy on post-operative sore throat	at post-anesthetic care unit and 24-h post-operative	Assess POST using scoring system and discomfort by interview. Sore throat scoring system is divided into 4 scores 0 means no sore throat; 1. means minimal sore throat (less severe than cold); 2. means moderate sore throat (similar to cold); 3. means severe sore throat (more severe than cold)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of anesthesiology, Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand