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Does Strepsils® With Lignocaine Lozenges Reduce Post Operative Sore Throat Due To Supraglottic Airway Devices

NCT03944655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-01-28

No results posted yet for this study

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.

Conditions

  • Sore Throat
  • Post Operative Sore Throat

Interventions

DRUG

Strepsils Anaesthetic Formula

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.

DIETARY_SUPPLEMENT

Clear Mint Drops

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

Sponsors & Collaborators

  • Dr Sebastian Sundaraj

    lead OTHER

Principal Investigators

  • Sebastian Sundaraj, MD · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03944655 on ClinicalTrials.gov