Sore ThroatNCT01444703
Comparison of Licorice Versus Sugar-water Gargle for Prevention of Postoperative Sore Throat and Postextubation Coughing
A study testing licorice solution and sugar solution in people with Sore Throat, run by The Cleveland Clinic at 1 site in Austria.
Trial summary
The investigators propose to test the hypothesis that pre-operative gargling with licorice reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal tubes compared to placebo after surgery through the first four post-extubation hours. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sore Throat
- What is being tested?
- licorice solution and sugar solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2010to Jun 2011
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thoracic surgery with anticipated use of a double-lumen endotracheal tube;
- Anticipated extubation in the operating room;
- ASA Physical Status 1-3;
- Age 18- 90
Who cannot join
- Tracheal pathology, including tracheostomy;
- Surgery within the previous four weeks;
- Upper-respiratory tract infection;
- BMI higher exceeding 40 kg/m2;
- Known or suspected allergy to licorice;
- Use of non-steroidal anti-inflammatory drug medication within 24 hours;
Show all 9Show fewer
- Chronic opioid use;
- Preoperative pain ≥ 2 on an 11-point Likert scale (0 = no pain; 10 = worst pain);
- Known or suspected difficult airway.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Universitätsklinik für Anästhesie, Intensivmedizin und Schmerztherapie an der medizinischen Universität Wien
Vienna
About this study
Official title: Randomized, Double-blind Comparison of Licorice Versus Sugar-water Gargle for Prevention of Postoperative Sore Throat and Postextubation Coughing
The investigators propose to test the hypothesis that pre-operative gargling with licorice reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal tubes compared to placebo after surgery through the first four post-extubation hours.
Read the detailed description
Patients will be premedicated with up to 7.5 mg p.o. midazolam, per routine. They will be told that the study involves two different solutions for prevention of post-extubation sore throat.
Patients will be randomly assigned to gargle 5 minutes before induction of general anesthesia with: 1) licorice (0.5 g); or, 2) sugar (5 g). Randomization will be based on a computer-generated table of random numbers. Licorice or sugar (placebo) will be diluted in 30 ml water and filled in a small bottle by an independent apothecary of our university. All bottles will look similar and will not be opened until just before use. Investigator and patient will be blinded to the preparation used for gargle. Patients will be asked to gargle for two minutes, but not to swallow the solution.
General anesthesia will be induced with fentanyl ≈3 µg/kg, propofol ≈1.5 mg/kg, and rocuronium ≈0.6 mg/kg. Complete muscle relaxation will be confirmed by absence of palpable twitches in response to supra-maximal train-of-four stimulation of the ulnar nerve at the wrist. The trachea will then be intubated as gentle as possible. Intubation will be attempted with a Macintosh laryngoscope, but the anesthesiologists may subsequently use any other intubation equipment as necessary. Initial tube size will be 37 cm left in women and 39 cm left for men; however, other sizes can be used if clinically necessary. Endotracheal tube cuffs will be inflated with air to 20-25 mmHg as necessary to maintain an adequate seal.
General anesthesia will be primarily be maintained with sevoflurane. Patients lungs will be ventilated with O2 in air, usually with an inspired oxygen fraction (FiO2) of ≈40%. However, additional oxygen will be provided as clinically necessary, especially during one-lung ventilation. End-tidal CO2 will be maintained between 32 and 35 mmHg as clinically practical. Deep of anesthesia will be monitored by using bispectral index BIS, kept between 40 and 50. Small amounts of opioid will be permitted during surgery and in preparation for extubation. At the end of surgery, an intercostal plexus block -using up to 20 ml Ropivacaine 0.1% - will be performed by the surgeons. 1000 mg paracetamol will be given intravenously ten minutes before end of surgery. Post operative pain will be treated with fractional piritramid (Dipidolor) 3 mg IV as required.
- Conditions
- Sore Throat
- Being tested
- licorice solution, sugar solution
- Keywords
- Thoracic surgery, double-lumen endotracheal tube, intubation, extubation, sore throat, prevention of post-extubation sore throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
licorice solutionOther
licorice (0.5 g)
sugar solutionOther
sugar (5 g).
| Study group | Role | What they receive |
|---|---|---|
| sugar solution | Placebo comparator | Gargle 5 minutes before induction of general anesthesia with sugar solution. Receives: Other: sugar solution |
| licorice | Active comparator | Gargle 5 minutes before induction of general anesthesia with licorice solution. Receives: Other: licorice solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
sore throat in rest after intubation
We propose to test the hypothesis that pre-operative gargling with licorice reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal tubes compared to placebo after surgery through the first four post-extubation hours.
Measured: up to 4 hours post-extubation
Secondary outcomes (4)
post-extubation coughing
Pre-operative gargling with licorice reduces sore throat pain during the initial postoperative day. Pre-operative gargling with licorice reduces the incidence of post-extubation coughing.
Measured: up to four hours post-extubation
amount of coughing
Pre-operative gargling with licorice reduces the amount of coughing during the remainder of the first postoperative day.
Measured: 24 hours post operative
sore throat in rest
Pre-operative gargling with licorice reduces the incidence of sore throat in rest and during swallowing within the first 24 hours
Measured: first 24 hours after surgrey
incidence of sore throat during swallowing
Pre-operative gargling with licorice reduces the incidence of sore throat in rest and during swallowing within the first 24 hours
Measured: first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, d sessler, Outcomes Research Consortium
- Investigators
- Daniel Sessler, MD, Study chair, Outcomes Research Consortium, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444703
- Sponsor's protocol ID
- 332/2010
- Status last verified
- Jul 2016
- First submitted
- 23 Sep 2011
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ruetzler K, Fleck M, Nabecker S, Pinter K, Landskron G, Lassnigg A, You J, Sessler DI. A randomized, double-blind comparison of licorice versus sugar-water gargle for prevention of postoperative sore throat and postextubation coughing. Anesth Analg. 2013 Sep;117(3):614-621. doi: 10.1213/ANE.0b013e318299a650. Epub 2013 Aug 6.
PubMed 23921656
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Comparison of Licorice Versus Sugar-water Gargle for Prevention of Postoperative Sore Throat and Postextubation Coughing
- ClinicalTrials.gov ID
- NCT01444703
- Acronym / sponsor ID
- 332/2010
- Conditions
- Sore Throat
- Keywords
- Thoracic surgery, double-lumen endotracheal tube, intubation, extubation, sore throat, prevention of post-extubation sore throat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Oct 2011 (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.
The investigators propose to test the hypothesis that pre-operative gargling with licorice reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal tubes compared to placebo after surgery through the first four post-extubation hours.
Detailed description
Patients will be premedicated with up to 7.5 mg p.o. midazolam, per routine. They will be told that the study involves two different solutions for prevention of post-extubation sore throat.
Patients will be randomly assigned to gargle 5 minutes before induction of general anesthesia with: 1) licorice (0.5 g); or, 2) sugar (5 g). Randomization will be based on a computer-generated table of random numbers. Licorice or sugar (placebo) will be diluted in 30 ml water and filled in a small bottle by an independent apothecary of our university. All bottles will look similar and will not be opened until just before use. Investigator and patient will be blinded to the preparation used for gargle. Patients will be asked to gargle for two minutes, but not to swallow the solution.
General anesthesia will be induced with fentanyl ≈3 µg/kg, propofol ≈1.5 mg/kg, and rocuronium ≈0.6 mg/kg. Complete muscle relaxation will be confirmed by absence of palpable twitches in response to supra-maximal train-of-four stimulation of the ulnar nerve at the wrist. The trachea will then be intubated as gentle as possible. Intubation will be attempted with a Macintosh laryngoscope, but the anesthesiologists may subsequently use any other intubation equipment as necessary. Initial tube size will be 37 cm left in women and 39 cm left for men; however, other sizes can be used if clinically necessary. Endotracheal tube cuffs will be inflated with air to 20-25 mmHg as necessary to maintain an adequate seal.
General anesthesia will be primarily be maintained with sevoflurane. Patients lungs will be ventilated with O2 in air, usually with an inspired oxygen fraction (FiO2) of ≈40%. However, additional oxygen will be provided as clinically necessary, especially during one-lung ventilation. End-tidal CO2 will be maintained between 32 and 35 mmHg as clinically practical. Deep of anesthesia will be monitored by using bispectral index BIS, kept between 40 and 50. Small amounts of opioid will be permitted during surgery and in preparation for extubation. At the end of surgery, an intercostal plexus block -using up to 20 ml Ropivacaine 0.1% - will be performed by the surgeons. 1000 mg paracetamol will be given intravenously ten minutes before end of surgery. Post operative pain will be treated with fractional piritramid (Dipidolor) 3 mg IV as required.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugar solution | Placebo comparator | Other: sugar solutionGargle 5 minutes before induction of general anesthesia with sugar solution. |
| licorice | Active comparator | Other: licorice solutionGargle 5 minutes before induction of general anesthesia with licorice solution. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Thoracic surgery with anticipated use of a double-lumen endotracheal tube;
- Anticipated extubation in the operating room;
- ASA Physical Status 1-3;
- Age 18- 90
Key exclusion criteria (9 listed)
- Tracheal pathology, including tracheostomy;
- Surgery within the previous four weeks;
- Upper-respiratory tract infection;
- BMI higher exceeding 40 kg/m2;
- Known or suspected allergy to licorice;
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 |
|---|---|---|
| licorice solutionlicorice (0.5 g) | Other | licorice |
| sugar solutionsugar (5 g). | Other | sugar solution |
Primary outcome
sore throat in rest after intubation
Time frame: up to 4 hours post-extubation
We propose to test the hypothesis that pre-operative gargling with licorice reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal tubes compared to placebo after surgery through the first four post-extubation hours.
4 secondary outcomes
post-extubation coughing
Time frame: up to four hours post-extubation
amount of coughing
Time frame: 24 hours post operative
sore throat in rest
Time frame: first 24 hours after surgrey
incidence of sore throat during swallowing
Time frame: first 24 hours after surgery
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 20 Jul 2016.
- Results publication: PubMed 23921656Ruetzler K, Fleck M, Nabecker S, Pinter K, Landskron G, Lassnigg A, You J, Sessler DI. A randomized, double-blind comparison of licorice versus sugar-water gargle for prevention of postoperative sore throat and postextubation coughing. Anesth Analg. 2013 Sep;117(3):614-621. doi: 10.1213/ANE.0b013e318299a650. Epub 2013 Aug 6.
- Individual participant dataSharing planned: No
Related trials for Sore Throat
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
RecruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
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.
Daniel Sessler, MD study chair
Outcomes Research Consortium, Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing licorice solution and sugar solution in people with Sore Throat, run by The Cleveland Clinic at 1 site in Austria.
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 4 inclusion and 9 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 20 Jul 2016. 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 Austria. 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. 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.
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?
sore throat in rest after intubation (time frame: up to 4 hours post-extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01444703, which also lists 1 linked publication.
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 20 Jul 2016.