NCT03944655

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

May 5, 2019

Last Update Submit

January 25, 2020

Conditions

Sore ThroatPost Operative Sore Throat

Keywords

Post operative sore throatPost operative dysphagiaPost operative dysphonia

Outcome Measures

Primary Outcomes (2)

  • Incidence of sore throat

    Presence of sore throat defined as constant pain, independent of swallowing

    30 minutes after the removal of Supraglottic Airway Device

  • Incidence of sore throat

    Presence of sore throat defined as constant pain, independent of swallowing

    24 hours after the removal of Supraglottic Airway Device

Secondary Outcomes (12)

  • Severity of sorethroat

    30 minutes after the removal of Supraglottic Airway Device

  • Severity of sorethroat

    24 hours after the removal of Supraglottic Airway Device

  • Incidence of dysphagia

    30 minutes after the removal of Supraglottic Airway Device

  • Incidence of dysphagia

    24 hours after the removal of Supraglottic Airway Device

  • Incidence of dysphonia

    30 minutes after the removal of Supraglottic Airway Device

  • +7 more secondary outcomes

Study Arms (2)

Strepsils

ACTIVE COMPARATOR
Drug: Strepsils Anaesthetic Formula

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Clear Mint Drops

Interventions

Strepsils Anaesthetic FormulaDRUG

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.

Also known as: Strepsils Max Plus
Strepsils
Clear Mint DropsDIETARY_SUPPLEMENT

Oral administration of a lozenge containing glucose syrup, sugar, and flavourings

Placebo

Eligibility Criteria

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

You may qualify if:

  • Greater than 18 years of age
  • American Society of Anesthesiologists Class I-II
  • Supraglottic Airway Device usage duration \< 2 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (13)

  • 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.

    PMID: 27158989BACKGROUND

  • Macario 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.

    PMID: 10475299BACKGROUND

  • Higgins 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.

    PMID: 12066737BACKGROUND

  • Wong 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.

    PMID: 24097301BACKGROUND

  • L'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.

    PMID: 27755181BACKGROUND

  • Tanaka 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.

    PMID: 26171894BACKGROUND

  • Weckmann 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.

    PMID: 28869700BACKGROUND

  • Ebneshahidi 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.

    PMID: 20142339BACKGROUND

  • Gupta 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.

    PMID: 24843341BACKGROUND

  • Smith 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.

    PMID: 21712716BACKGROUND

  • Ouanes 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.

    PMID: 25442242BACKGROUND

  • Bouvet 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.

    PMID: 29077816BACKGROUND

  • Timmermann 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.

    PMID: 26539790BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Sebastian Sundaraj, MD

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

May 5, 2019

First Posted

May 9, 2019

Study Start

January 17, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)