Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

Pain, Postoperative Clinical Trial

— POST  

Official title:

Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763177
• Other study ID #: EC56-008-08-1-1
• Status: Completed
• Phase: N/A
• First received: January 4, 2013
• Last updated: November 15, 2015
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1036
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Pharyngitis

Intervention

Other:
• Oxygen
Oxygen mask 40% 8 LPM for 30 minutes

Locations

Country	Name	City	State
Thailand	Department of anesthesiology, Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

oxygen nebulizer AND sore throat

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of oxygen nebulizer therapy on post-operative sore throat	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)	at post-anesthetic care unit and 24-h post-operative	Yes
Secondary	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	Yes

External Links

•   oxygen nebulizer AND sore throat