Sore ThroatPOSTrepsilsNCT03944655
Does Strepsils® With Lignocaine Lozenges Reduce Post Operative Sore Throat Due To Supraglottic Airway Devices
A study testing Strepsils Anaesthetic Formula and Clear Mint Drops in people with Sore Throat and Post Operative Sore Throat, run by Dr Sebastian Sundaraj at 1 site in Malaysia.
Trial summary
The primary objective of this study is to assess the effect of preoperative administration of oral Strepsils® with added Lignocaine lozenges on the incidence of postoperative sore throat (POST) after general anaesthesia using a Supraglottic Airway Device (SAD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sore Throat, Post Operative Sore Throat
- What is being tested?
- Strepsils Anaesthetic Formula and Clear Mint Drops
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteMalaysia
- Study dates
- 17 Jan 2019to 31 Aug 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Greater than 18 years of age
- American Society of Anesthesiologists Class I-II
- Supraglottic Airway Device usage duration < 2 hours
Who cannot join
- History of upper respiratory tract infection, sore throat, dysphonia, or dysphagia in the past 2 weeks
- Morbidly obese (body mass index >35 kg/m2)
- Increased risk of regurgitation or aspiration (eg. symptomatic gastro-oesophageal reflux, hiatus hernia)
- Pregnant or nursing
- Known allergies to study drug
- More than one attempt at Supraglottic Airway Device insertion or use of adjuncts during insertion
- Insertion/presence of a gastric tube
- Expected airway difficulties or conversion to endotracheal tube
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 50603
About this study
The primary objective of this study is to assess the effect of preoperative administration of oral Strepsils® with added Lignocaine lozenges on the incidence of postoperative sore throat (POST) after general anaesthesia using a Supraglottic Airway Device (SAD).
Patients undergoing surgery with general anaesthesia will require ventilation of their lungs with either a flexible tube placed beyond the voice box called an endotracheal tube (ETT) or a tube placed above the voice box called a Supraglottic Airway Device. This tube helps oxygenate the patient and delivers anaesthetic gas to the lungs.
Read more
The procedure is invasive and uncomfortable, and one of the most common complaints is a sore and inflamed throat after the tube is taken out. This is termed postoperative sore throat (POST). The incidence of POST after SAD is comparable with the ETT and though many studies have focused on ETT, few have examined the SAD.
After written informed consent is received in pre-op, a sealed and coded envelope with either the Strepsils lozenges or the placebo lozenges will be given to the patient to be administered orally, with the instruction to dissolve the lozenge by sucking on it 45 minutes prior to surgery. Upon completion of surgery and emergence from general anaesthesia, the patient will be assessed regarding the incidence and severity of sore throat, difficulty in swallowing and difficulty in speaking by the investigator using an interview format. The severity of these symptoms will be graded on a 4-point scale ranging from 0 to 3; 0 being no symptoms, 1 being mild symptoms, 2 being moderate symptoms, and 3 being severe symptoms. This evaluation will be performed at 30 minutes and 24 hours post removal of SAD.
Read the detailed description
The incidence of postoperative sore throat (POST) has been reported up to 62% following general anaesthesia with varying severity from mild to severe. It is among the top undesirable events experienced by patients after anaesthesia. The supraglottic airway device (SAD) is commonly used as an airway device during the delivery of general anaesthesia. The incidence of POST after SAD use has been documented of up to 49% and is comparable with the incidence of up to 45% when using an endotracheal tube (ETT).
Many studies have been evaluating the occurrence of POST with the use of an ETT but studies investigating POST and the use of SAD are limited. A recent study comparing sore throat following three SADs (LMA™ Unique, LMA™ Supreme and I-gel®) found that the incidence of POST was not significantly different between any of them.
There are various drugs being extensively investigated to reduce the incidence and severity of POST such as Lignocaine, Dexamethasone, NSAIDs, Liquorice and NMDA receptor antagonists [1]. A Cochrane review on the use of Lignocaine for endotracheal intubation concluded that Lignocaine applied topically or administered systemically resulted in reduced risk and severity of POST.
Amylmetacresol and Dichlorobenzyl Alcohol, the active ingredient in the standard preparation of Strepsils® lozenges has been shown to reduce the intensity of sore throat in non-anaesthetised subjects, including one study involving Strepsils® Max Plus lozenges which additionally contains Lignocaine, a local anaesthetic agent. Currently studies that evaluated POST after endotracheal intubation using the standard preparation of Strepsils® (without Lignocaine) have reported a reduction in the incidence and severity of POST.
The effect of Strepsils® Max Plus (with Lignocaine) lozenges on POST and particularly due to SAD is not known and is the basis of this study. It is the investigator's hypothesis that Strepsils® with added Lignocaine will reduce the incidence and severity of POST based on existing studies that showed the individual and combined beneficial effect of both substances.
The goal of this study is to identify a simple, safe, and inexpensive perioperative intervention to reduce the incidence and severity of post operative sore throat due to supraglottic airway devices.
Eligible participants include adult patients scheduled to undergo elective surgery under general anaesthesia using a supraglottic airway device. This study is a prospective, randomised, double-blinded study involving 60 subjects and they will assessed on the incidence and severity of sore throat, dysphagia and dysphonia at 30 minutes and 24 hours after removal of the supraglottic airway device using an interview format.
Outcomes from this study can be extended to patients who will be receiving general anaesthesia using a supraglottic airway device in the future.
- Conditions
- Sore Throat, Post Operative Sore Throat
- Being tested
- Strepsils Anaesthetic Formula, Clear Mint Drops
- Keywords
- Post operative sore throat, Post operative dysphagia, Post operative dysphonia
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strepsils Anaesthetic FormulaDrug
Also called Strepsils Max Plus
Oral administration of a Strepsils® Max Plus lozenge containing the active ingredients amylmetacresol 0.6 mg, 2,4-dichlorobenzyl alcohol 1.2 mg, lignocaine hydrochloride 10mg with sweeteners and flavourings.
Clear Mint DropsDietary supplement
Oral administration of a lozenge containing glucose syrup, sugar, and flavourings
| Study group | Role | What they receive |
|---|---|---|
| Strepsils | Active comparator | Not described Receives: Drug: Strepsils Anaesthetic Formula |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Clear Mint Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sore throat
Presence of sore throat defined as constant pain, independent of swallowing
Measured: 30 minutes after the removal of Supraglottic Airway Device
Incidence of sore throat
Presence of sore throat defined as constant pain, independent of swallowing
Measured: 24 hours after the removal of Supraglottic Airway Device
Secondary outcomes (12)
Severity of sorethroat
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Measured: 30 minutes after the removal of Supraglottic Airway Device
Severity of sorethroat
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Measured: 24 hours after the removal of Supraglottic Airway Device
Incidence of dysphagia
Presence of dysphagia defined as difficulty or pain provoked by swallowing
Measured: 30 minutes after the removal of Supraglottic Airway Device
Incidence of dysphagia
Presence of dysphagia defined as difficulty or pain provoked by swallowing
Measured: 24 hours after the removal of Supraglottic Airway Device
Incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking
Measured: 30 minutes after the removal of Supraglottic Airway Device
Incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking
Measured: 24 hours after the removal of Supraglottic Airway Device
Severity of dysphagia
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Measured: 30 minutes after the removal of Supraglottic Airway Device
Severity of dysphagia
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Measured: 24 hours after the removal of Supraglottic Airway Device
Severity of dysphonia
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Measured: 30 minutes after the removal of Supraglottic Airway Device
Severity of dysphonia
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Measured: 24 hours after the removal of Supraglottic Airway Device
Adverse effects of study drug
Any untoward medical occurrence in a subject administered an investigational product and which does not necessarily have a causal relationship with treatment.
Measured: 30 minutes after the removal of Supraglottic Airway Device
Adverse effects of study drug
Any untoward medical occurrence in a subject administered an investigational product and which does not necessarily have a causal relationship with treatment.
Measured: 24 hours after the removal of Supraglottic Airway Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start17 Jan 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Sebastian Sundaraj
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Sebastian Sundaraj, University of Malaya
- Investigators
- Sebastian Sundaraj, MD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944655
- Sponsor's protocol ID
- 201887-6582
- Acronym
- POSTrepsils
- Status last verified
- Jan 2020
- First submitted
- 5 May 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
PubMed 27158989Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
PubMed 10475299Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.
PubMed 12066737Wong DT, Tam AD, Mehta V, Raveendran R, Riad W, Chung FF. New supraglottic airway with built-in pressure indicator decreases postoperative pharyngolaryngeal symptoms: a randomized controlled trial. Can J Anaesth. 2013 Dec;60(12):1197-203. doi: 10.1007/s12630-013-0044-2. Epub 2013 Oct 5.
PubMed 24097301L'Hermite J, Dubout E, Bouvet S, Bracoud LH, Cuvillon P, Coussaye JE, Ripart J. Sore throat following three adult supraglottic airway devices: A randomised controlled trial. Eur J Anaesthesiol. 2017 Jul;34(7):417-424. doi: 10.1097/EJA.0000000000000539.
PubMed 27755181Tanaka Y, Nakayama T, Nishimori M, Tsujimura Y, Kawaguchi M, Sato Y. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD004081. doi: 10.1002/14651858.CD004081.pub3.
PubMed 26171894Weckmann G, Hauptmann-Voss A, Baumeister SE, Klotzer C, Chenot JF. Efficacy of AMC/DCBA lozenges for sore throat: A systematic review and meta-analysis. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.13002. Epub 2017 Sep 4.
PubMed 28869700Ebneshahidi A, Mohseni M. Strepsils(R) tablets reduce sore throat and hoarseness after tracheal intubation. Anesth Analg. 2010 Oct;111(4):892-4. doi: 10.1213/ANE.0b013e3181d00c60. Epub 2010 Feb 8.
PubMed 20142339Gupta D, Agrawal S, Sharma JP. Evaluation of preoperative Strepsils lozenges on incidence of postextubation cough and sore throat in smokers undergoing anesthesia with endotracheal intubation. Saudi J Anaesth. 2014 Apr;8(2):244-8. doi: 10.4103/1658-354X.130737.
PubMed 24843341Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
PubMed 21712716Ouanes JP, Bicket MC, Togioka B, Tomas VG, Wu CL, Murphy JD. The role of perioperative chewing gum on gastric fluid volume and gastric pH: a meta-analysis. J Clin Anesth. 2015 Mar;27(2):146-52. doi: 10.1016/j.jclinane.2014.07.005. Epub 2014 Nov 28.
PubMed 25442242Bouvet L, Loubradou E, Desgranges FP, Chassard D. Effect of gum chewing on gastric volume and emptying: a prospective randomized crossover study. Br J Anaesth. 2017 Nov 1;119(5):928-933. doi: 10.1093/bja/aex270.
PubMed 29077816Timmermann A, Bergner UA, Russo SG. Laryngeal mask airway indications: new frontiers for second-generation supraglottic airways. Curr Opin Anaesthesiol. 2015 Dec;28(6):717-26. doi: 10.1097/ACO.0000000000000262.
PubMed 26539790
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Strepsils® With Lignocaine Lozenges Reduce Post Operative Sore Throat Due To Supraglottic Airway Devices
- ClinicalTrials.gov ID
- NCT03944655
- Acronym / sponsor ID
- POSTrepsils / 201887-6582
- Conditions
- Sore Throat, Post Operative Sore Throat
- Keywords
- Post operative sore throat, Post operative dysphagia, Post operative dysphonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Dr Sebastian SundarajUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 9 May 2019 (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 primary objective of this study is to assess the effect of preoperative administration of oral Strepsils® with added Lignocaine lozenges on the incidence of postoperative sore throat (POST) after general anaesthesia using a Supraglottic Airway Device (SAD).
Patients undergoing surgery with general anaesthesia will require ventilation of their lungs with either a flexible tube placed beyond the voice box called an endotracheal tube (ETT) or a tube placed above the voice box called a Supraglottic Airway Device. This tube helps oxygenate the patient and delivers anaesthetic gas to the lungs.
The procedure is invasive and uncomfortable, and one of the most common complaints is a sore and inflamed throat after the tube is taken out. This is termed postoperative sore throat (POST). The incidence of POST after SAD is comparable with the ETT and though many studies have focused on ETT, few have examined the SAD.
After written informed consent is received in pre-op, a sealed and coded envelope with either the Strepsils lozenges or the placebo lozenges will be given to the patient to be administered orally, with the instruction to dissolve the lozenge by sucking on it 45 minutes prior to surgery. Upon completion of surgery and emergence from general anaesthesia, the patient will be assessed regarding the incidence and severity of sore throat, difficulty in swallowing and difficulty in speaking by the investigator using an interview format. The severity of these symptoms will be graded on a 4-point scale ranging from 0 to 3; 0 being no symptoms, 1 being mild symptoms, 2 being moderate symptoms, and 3 being severe symptoms. This evaluation will be performed at 30 minutes and 24 hours post removal of SAD.
Detailed description
The incidence of postoperative sore throat (POST) has been reported up to 62% following general anaesthesia with varying severity from mild to severe. It is among the top undesirable events experienced by patients after anaesthesia. The supraglottic airway device (SAD) is commonly used as an airway device during the delivery of general anaesthesia. The incidence of POST after SAD use has been documented of up to 49% and is comparable with the incidence of up to 45% when using an endotracheal tube (ETT).
Many studies have been evaluating the occurrence of POST with the use of an ETT but studies investigating POST and the use of SAD are limited. A recent study comparing sore throat following three SADs (LMA™ Unique, LMA™ Supreme and I-gel®) found that the incidence of POST was not significantly different between any of them.
There are various drugs being extensively investigated to reduce the incidence and severity of POST such as Lignocaine, Dexamethasone, NSAIDs, Liquorice and NMDA receptor antagonists [1]. A Cochrane review on the use of Lignocaine for endotracheal intubation concluded that Lignocaine applied topically or administered systemically resulted in reduced risk and severity of POST.
Amylmetacresol and Dichlorobenzyl Alcohol, the active ingredient in the standard preparation of Strepsils® lozenges has been shown to reduce the intensity of sore throat in non-anaesthetised subjects, including one study involving Strepsils® Max Plus lozenges which additionally contains Lignocaine, a local anaesthetic agent. Currently studies that evaluated POST after endotracheal intubation using the standard preparation of Strepsils® (without Lignocaine) have reported a reduction in the incidence and severity of POST.
The effect of Strepsils® Max Plus (with Lignocaine) lozenges on POST and particularly due to SAD is not known and is the basis of this study. It is the investigator's hypothesis that Strepsils® with added Lignocaine will reduce the incidence and severity of POST based on existing studies that showed the individual and combined beneficial effect of both substances.
The goal of this study is to identify a simple, safe, and inexpensive perioperative intervention to reduce the incidence and severity of post operative sore throat due to supraglottic airway devices.
Eligible participants include adult patients scheduled to undergo elective surgery under general anaesthesia using a supraglottic airway device. This study is a prospective, randomised, double-blinded study involving 60 subjects and they will assessed on the incidence and severity of sore throat, dysphagia and dysphonia at 30 minutes and 24 hours after removal of the supraglottic airway device using an interview format.
Outcomes from this study can be extended to patients who will be receiving general anaesthesia using a supraglottic airway device in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strepsils | Active comparator | Drug: Strepsils Anaesthetic Formula |
| Placebo | Placebo comparator | Dietary Supplement: Clear Mint Drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 18 years of age
- American Society of Anesthesiologists Class I-II
- Supraglottic Airway Device usage duration < 2 hours
Key exclusion criteria (8 listed)
- History of upper respiratory tract infection, sore throat, dysphonia, or dysphagia in the past 2 weeks
- Morbidly obese (body mass index >35 kg/m2)
- Increased risk of regurgitation or aspiration (eg. symptomatic gastro-oesophageal reflux, hiatus hernia)
- Pregnant or nursing
- Known allergies to study drug
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 |
|---|---|---|
| Strepsils Anaesthetic FormulaAlso: Strepsils Max PlusOral administration of a Strepsils® Max Plus lozenge containing the active ingredients amylmetacresol 0.6 mg, 2,4-dichlorobenzyl alcohol 1.2 mg, lignocaine hydrochloride 10mg with sweeteners and flavourings. | Drug | Strepsils |
| Clear Mint DropsOral administration of a lozenge containing glucose syrup, sugar, and flavourings | Dietary supplement | Placebo |
Primary outcome
Incidence of sore throat
Time frame: 30 minutes after the removal of Supraglottic Airway Device
Presence of sore throat defined as constant pain, independent of swallowing
Incidence of sore throat
Time frame: 24 hours after the removal of Supraglottic Airway Device
Presence of sore throat defined as constant pain, independent of swallowing
12 secondary outcomes
Severity of sorethroat
Time frame: 30 minutes after the removal of Supraglottic Airway Device
Severity of sorethroat
Time frame: 24 hours after the removal of Supraglottic Airway Device
Incidence of dysphagia
Time frame: 30 minutes after the removal of Supraglottic Airway Device
Incidence of dysphagia
Time frame: 24 hours after the removal of Supraglottic Airway Device
Incidence of dysphonia
Time frame: 30 minutes after the removal of Supraglottic Airway Device
Incidence of dysphonia
Time frame: 24 hours after the removal of Supraglottic Airway Device
Severity of dysphagia
Time frame: 30 minutes after the removal of Supraglottic Airway Device
Severity of dysphagia
Time frame: 24 hours after the removal of Supraglottic Airway Device
Severity of dysphonia
Time frame: 30 minutes after the removal of Supraglottic Airway Device
Severity of dysphonia
Time frame: 24 hours after the removal of Supraglottic Airway Device
Adverse effects of study drug
Time frame: 30 minutes after the removal of Supraglottic Airway Device
Adverse effects of study drug
Time frame: 24 hours after the removal of Supraglottic Airway Device
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 28 Jan 2020.
- Background: PubMed 27158989El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
- Background: PubMed 10475299Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
- Background: PubMed 12066737Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.
- Background: PubMed 24097301Wong DT, Tam AD, Mehta V, Raveendran R, Riad W, Chung FF. New supraglottic airway with built-in pressure indicator decreases postoperative pharyngolaryngeal symptoms: a randomized controlled trial. Can J Anaesth. 2013 Dec;60(12):1197-203. doi: 10.1007/s12630-013-0044-2. Epub 2013 Oct 5.
- Background: PubMed 27755181L'Hermite J, Dubout E, Bouvet S, Bracoud LH, Cuvillon P, Coussaye JE, Ripart J. Sore throat following three adult supraglottic airway devices: A randomised controlled trial. Eur J Anaesthesiol. 2017 Jul;34(7):417-424. doi: 10.1097/EJA.0000000000000539.
- Background: PubMed 26171894Tanaka Y, Nakayama T, Nishimori M, Tsujimura Y, Kawaguchi M, Sato Y. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD004081. doi: 10.1002/14651858.CD004081.pub3.
- Background: PubMed 28869700Weckmann G, Hauptmann-Voss A, Baumeister SE, Klotzer C, Chenot JF. Efficacy of AMC/DCBA lozenges for sore throat: A systematic review and meta-analysis. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.13002. Epub 2017 Sep 4.
- Background: PubMed 20142339Ebneshahidi A, Mohseni M. Strepsils(R) tablets reduce sore throat and hoarseness after tracheal intubation. Anesth Analg. 2010 Oct;111(4):892-4. doi: 10.1213/ANE.0b013e3181d00c60. Epub 2010 Feb 8.
- Background: PubMed 24843341Gupta D, Agrawal S, Sharma JP. Evaluation of preoperative Strepsils lozenges on incidence of postextubation cough and sore throat in smokers undergoing anesthesia with endotracheal intubation. Saudi J Anaesth. 2014 Apr;8(2):244-8. doi: 10.4103/1658-354X.130737.
- Background: PubMed 21712716Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
- Background: PubMed 25442242Ouanes JP, Bicket MC, Togioka B, Tomas VG, Wu CL, Murphy JD. The role of perioperative chewing gum on gastric fluid volume and gastric pH: a meta-analysis. J Clin Anesth. 2015 Mar;27(2):146-52. doi: 10.1016/j.jclinane.2014.07.005. Epub 2014 Nov 28.
- Background: PubMed 29077816Bouvet L, Loubradou E, Desgranges FP, Chassard D. Effect of gum chewing on gastric volume and emptying: a prospective randomized crossover study. Br J Anaesth. 2017 Nov 1;119(5):928-933. doi: 10.1093/bja/aex270.
- 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.
Sebastian Sundaraj, MD principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strepsils Anaesthetic Formula and Clear Mint Drops in people with Sore Throat and Post Operative Sore Throat, run by Dr Sebastian Sundaraj at 1 site in Malaysia.
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 8 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 28 Jan 2020. 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 Malaysia. 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?
Incidence of sore throat (time frame: 30 minutes after the removal of Supraglottic Airway Device). The study lists 2 primary outcomes in all. 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 NCT03944655, which also lists 13 linked publications.
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 28 Jan 2020.