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

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ClinicalTrials.gov Identifier: NCT01763177
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : November 17, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Pain, Postoperative Other: Oxygen

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1036 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat
Study Start Date : January 2013
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01763177     History of Changes
Other Study ID Numbers: EC56-008-08-1-1
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases