Sore ThroatPhase 4NCT02952157
Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff
A Phase 4 study testing Lidocaine jelly application and Normal saline application in people with Sore Throat, run by Keimyung University Dongsan Medical Center.
Trial summary
Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sore Throat
- What is being tested?
- Lidocaine jelly application and Normal saline application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Patients scheduled for general anesthesia with endotracheal intubation
- Patients scheduled for surgery which duration is expected to less than 3 hr
Who cannot join
- Difficult airway
- Rapid sequence induction
- Recent sore throat
- Recent upper respiratory infection
- Asthma
- Chronic obstructive pulmonary disease
Show all 15Show fewer
- Chronic cough
- Pregnancy
- Allergy to lidocaine
- Friable teeth
- History of head and neck surgery
- Multiple intubation attempts
- Regional anesthetic agents
- Gastric tube
- Dexamethasone
About this study
Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.
- Conditions
- Sore Throat
- Being tested
- Lidocaine jelly application, Normal saline application
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine jelly applicationDrug
Normal saline applicationDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Normal saline will be applied to the endotracheal tube. Receives: Drug: Normal saline application |
| Lidocaine | Active comparator | Lidocaine jelly will be applied to the endotracheal tube. Receives: Drug: Lidocaine jelly application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with sore throat
Measured: At 24 hr
Secondary outcomes (8)
Number of participants with sore throat
Measured: At 1, 6, and 12 hr
Number of participants with hoarseness
Measured: At 1, 6, 12 and 24 hr
Number of participants with throat numbness
Measured: At 1, 6, 12 and 24 hr
Number of participants with nausea
Measured: At 1, 6, 12 and 24 hr
Number of participants with vomiting
Measured: At 1, 6, 12 and 24 hr
Number of participants with cough
Measured: At 1, 6, 12 and 24 hr
Number of participants with dry mouth
Measured: At 1, 6, 12 and 24 hr
Number of participants with additional pain medication
Measured: At 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952157
- Sponsor's protocol ID
- LidoTaper
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff
- ClinicalTrials.gov ID
- NCT02952157
- Acronym / sponsor ID
- LidoTaper
- Conditions
- Sore Throat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- 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.
Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Drug: Normal saline applicationNormal saline will be applied to the endotracheal tube. |
| Lidocaine | Active comparator | Drug: Lidocaine jelly applicationLidocaine jelly will be applied to the endotracheal tube. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III
- Patients scheduled for general anesthesia with endotracheal intubation
- Patients scheduled for surgery which duration is expected to less than 3 hr
Key exclusion criteria (15 listed)
- Difficult airway
- Rapid sequence induction
- Recent sore throat
- Recent upper respiratory infection
- Asthma
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 |
|---|---|---|
| Lidocaine jelly application | Drug | Lidocaine |
| Normal saline application | Drug | Control |
Primary outcome
Number of participants with sore throat
Time frame: At 24 hr
8 secondary outcomes
Number of participants with sore throat
Time frame: At 1, 6, and 12 hr
Number of participants with hoarseness
Time frame: At 1, 6, 12 and 24 hr
Number of participants with throat numbness
Time frame: At 1, 6, 12 and 24 hr
Number of participants with nausea
Time frame: At 1, 6, 12 and 24 hr
Number of participants with vomiting
Time frame: At 1, 6, 12 and 24 hr
Number of participants with cough
Time frame: At 1, 6, 12 and 24 hr
Number of participants with dry mouth
Time frame: At 1, 6, 12 and 24 hr
Number of participants with additional pain medication
Time frame: At 24 hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine jelly application and Normal saline application in people with Sore Throat, run by Keimyung University Dongsan Medical Center.
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 15 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: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Number of participants with sore throat (time frame: At 24 hr). 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 2 Nov 2016.