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Completed

NCT Number: NCT04859101

Post-operative Sore Throat and Gum Chewing

The purpose of this study is to determine if chewing gum immediately prior to transport to the operating room reduces the severity of post-operative sore throat in patients who have an LMA (laryngeal mask airway) placed for procedures with duration greater than 1 hour.

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Key information

Conditions

Anesthesia Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

Patients will be randomized into two groups. Group 1 will receive a piece of gum immediately prior to transport to the operating room. They will be asked to chew the gum for 2 minutes and then spit the gum in the garbage. Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Outpatient ambulatory surgery
  • General anesthesia utilizing a laryngeal mask airway
  • Greater than 1 hour duration

Exclusion criteria

  • Chronic laryngitis
  • Chronic bronchitis
  • Asthma
  • Gastroesophageal reflux disease
  • Smoking within the last week
  • Non-English speaking

Treatment and study plan

Gum

Other

2 minutes of gum chewing prior to procedure

Control

Other

2 swallows prior to procedure

Primary outcomes

  1. Incidence of moderate to severe Post-operative Sore Throat within 24 hours

    Time frame: 24 hour

    Moderate to severe post-operative sore throat defined as greater than 3 on an 11-point Numeric Rating Scale; 0 being no sore throat, 10 being maximum imaginable sore throat

Secondary outcomes

  1. Satisfaction with Anesthesia

    Time frame: 24 hour

    5-point likert scale; very satisfied, satisfied, neutral, dissatisfied, very dissatisfied

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2021
Registry last updated
Sep 13, 2022

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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