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Completed

NCT Number: NCT01763177

Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of anesthesiology, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Other

Oxygen mask 40% 8 LPM for 30 minutes

Primary outcomes

  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

    • means minimal sore throat (less severe than cold)
    • means moderate sore throat (similar to cold)
    • means severe sore throat (more severe than cold)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Acronym: POST

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 8, 2013
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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