Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat (POST)

This study has been completed.
Information provided by (Responsible Party):
Panthila Rujirojindakul, Prince of Songkla University Identifier:
First received: January 4, 2013
Last updated: November 15, 2015
Last verified: November 2015

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.

Condition Intervention
Pain, Postoperative
Other: Oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

Resource links provided by NLM:

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • The effect of oxygen nebulizer therapy on post-operative sore throat [ Time Frame: at post-anesthetic care unit and 24-h post-operative ] [ Designated as safety issue: Yes ]

    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:
  • To evaluate the adverse events (pulmonary complications, wound infection, and mortality) of post-operative complications related to oxygen therapy [ Time Frame: 24-h post-op and 30-d mortality ] [ Designated as safety issue: Yes ]

Enrollment: 1036
Study Start Date: January 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No oxygen
No given oxygen at post-anesthetic care unit
Active Comparator: Oxygen
Oxygen nebulizer via face mask, Fraction of inspired oxygen (FiO2) 0.4, flow 8 liter per minute (LPM) for 30 minutes
Other: Oxygen
Oxygen mask 40% 8 LPM for 30 minutes


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT01763177

Department of anesthesiology, Faculty of Medicine, Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Principal Investigator: Panthila Rujirojindakul, MD Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
  More Information

Additional Information:
oxygen nebulizer AND sore throat

Responsible Party: Panthila Rujirojindakul, Assistant Professor Dr.Panthila Rujirojindakul, Prince of Songkla University Identifier: NCT01763177     History of Changes
Other Study ID Numbers: EC56-008-08-1-1
Study First Received: January 4, 2013
Last Updated: November 15, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
post-operative sore throat

Additional relevant MeSH terms:
Pain, Postoperative
Otorhinolaryngologic Diseases
Pathologic Processes
Pharyngeal Diseases
Postoperative Complications
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms
Stomatognathic Diseases processed this record on November 27, 2015