Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Prince of Songkla University
- Enrollment
- 1,036
- Locations
- 1
- Primary Endpoint
- The effect of oxygen nebulizer therapy on post-operative sore throat
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
No oxygen
No given oxygen at post-anesthetic care unit
Oxygen
Oxygen nebulizer via face mask, Fraction of inspired oxygen (FiO2) 0.4, flow 8 liter per minute (LPM) for 30 minutes
Intervention: Oxygen (Other)
Outcomes
Primary Outcomes
The effect of oxygen nebulizer therapy on post-operative sore throat
Time Frame: 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 Outcomes
- 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)
Investigators
Panthila Rujirojindakul
Assistant Professor Dr.Panthila Rujirojindakul
Prince of Songkla University