CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Strepsils Anaesthetic Formula +1 moredrug
Likely dose
Strepsils Anaesthetic Formula 0.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03944655
NCT03944655N/ACompleted

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

Dr Sebastian Sundaraj·interventional·Posted May 9, 2019·Updated Jan 28, 2020

In Brief

A clinical study evaluating Strepsils Anaesthetic Formula and Clear Mint Drops for Sore Throat and Post Operative Sore Throat. Completed, enrolled 88 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 9, 2019
Enrollment StartJan 17, 2019
Primary CompletionAug 31, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.1 years ago

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.

Clear Mint Dropsdietary

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