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Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

NCT ID: NCT01763177

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1036 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No oxygen

No given oxygen at post-anesthetic care unit

Group Type NO_INTERVENTION

No interventions assigned to this group

Oxygen

Oxygen nebulizer via face mask, Fraction of inspired oxygen (FiO2) 0.4, flow 8 liter per minute (LPM) for 30 minutes

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type OTHER

Oxygen mask 40% 8 LPM for 30 minutes

Interventions

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Oxygen

Oxygen mask 40% 8 LPM for 30 minutes

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Panthila Rujirojindakul

Assistant Professor Dr.Panthila Rujirojindakul

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Panthila Rujirojindakul, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

References

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oxygen nebulizer AND sore throat

Reference Type BACKGROUND

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/

oxygen nebulizer AND sore throat

Other Identifiers

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EC56-008-08-1-1

Identifier Type: -

Identifier Source: org_study_id