NCT04859101

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 21, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

April 21, 2021

Last Update Submit

September 11, 2022

Conditions

AnesthesiaSurgery

Outcome Measures

Primary Outcomes (1)

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

    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

    24 hour

Secondary Outcomes (1)

  • Satisfaction with Anesthesia

    24 hour

Study Arms (2)

Gum

EXPERIMENTAL

Group 1 will receive 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.

Other: Gum

Control

OTHER

Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention.

Other: Control

Interventions

GumOTHER

2 minutes of gum chewing prior to procedure

Gum
ControlOTHER

2 swallows prior to procedure

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jacob L Hutchins, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 26, 2021

Study Start

July 21, 2021

Primary Completion

April 30, 2022

Study Completion

May 1, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)