AnesthesiaNCT04859101
Post-operative Sore Throat and Gum Chewing
A study testing Gum in people with Anesthesia and Surgery, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Surgery
- What is being tested?
- Gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatient ambulatory surgery
- General anesthesia utilizing a laryngeal mask airway
- Greater than 1 hour duration
Who cannot join
- Chronic laryngitis
- Chronic bronchitis
- Asthma
- Gastroesophageal reflux disease
- Smoking within the last week
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Anesthesia, Surgery
- Being tested
- Gum, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GumOther
2 minutes of gum chewing prior to procedure
ControlOther
2 swallows prior to procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Gum |
| Control | Other | Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hour
Secondary outcomes (1)
Satisfaction with Anesthesia
5-point likert scale; very satisfied, satisfied, neutral, dissatisfied, very dissatisfied
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start21 Jul 2021
- Primary completion30 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob L Hutchins, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859101
- Sponsor's protocol ID
- ANES-2021-29683
- Status last verified
- Sep 2022
- First submitted
- 21 Apr 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04859101
- Acronym / sponsor ID
- ANES-2021-29683
- Conditions
- Anesthesia, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gum | Experimental | Other: GumGroup 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. |
| Control | Other | Other: ControlGroup 2 will not receive any gum. They will be asked to swallow twice and have no other intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatient ambulatory surgery
- General anesthesia utilizing a laryngeal mask airway
- Greater than 1 hour duration
Key exclusion criteria (6 listed)
- Chronic laryngitis
- Chronic bronchitis
- Asthma
- Gastroesophageal reflux disease
- Smoking within the last week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gum2 minutes of gum chewing prior to procedure | Other | Gum |
| Control2 swallows prior to procedure | Other | Control |
Primary outcome
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
1 secondary outcome
Satisfaction with Anesthesia
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob L Hutchins, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum in people with Anesthesia and Surgery, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of moderate to severe Post-operative Sore Throat within 24 hours (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.