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Completed

NCT Number: NCT06114771

The Evaluation of the Effect of Preoperatively Applied Throat Lozenge

Purpose:The aim of this study is to evaluate the effect of preoperative throat lozenge on pain relief in the postoperative period of the mucosal damage caused by intubation in patients who underwent operations in the head and neck region under general anesthesia.

Methods: 60 patients were included in this study who were hospitalized in the inpatient service of the Oral and Maxillofacial Surgery department, This study was single-blind and performed by the same practitioner. Throat lozenge (strepsilis) was given to patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes).The postoperative sore throat was evaluated by VAS scale (0=no pain, 10=unbearable pain), and cough and hoarseness were evaluated with a four-point Likert scale (0=absent, 3=severe) at 1, 4, 6, 12, and 24 hours.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raha

Ankara, Turkey (Türkiye)

About this study

Before the operation, blood sugar, urea, creatinine, electrolytes, prothrombin time, active partial thromboplastin time, and liver enzyme levels were determined in all patients. Hemoglobin and hematocrit determinations were made. Electrocardiography and chest radiographs were taken. Patients whose biochemical tests were within normal limits were included in our study.

The study was single-blind and performed by the same practitioner. Throat lozenge (strepsilis) was given to 30 patients, and sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes). In order not to cause any complications, sugar patients were sucked and told not to chew.

Before the initiation of general anesthesia, height, weight, intubation time, mallampati score and ASA classification, the name of the operation, the start and end time of the operation, smoking, tube number, and whether spasms occurred were recorded. Patients taken to the service in the postoperative period were rested by wearing an oxygen mask. Postoperative sore throat VAS scale (0 = no pain, 10 = unbearable pain), cough, and hoarseness were assessed at 1, 4, 6, 12, and 24 hours with a four-point Likert scale (0 = absent, 3 = severe).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Being over 18 years old Having ASA I and II scores Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets

Exclusion criteria

Being over 60 years old Complex intubation cases Insulin dependent diabetes Thyroid disease

Treatment and study plan

strepsilis

Other

Throat lozenge (strepsilis) was given to patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes).

Placebo

Other

Sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation. In order not to cause any complications, sugar patients were sucked and told not to chew.

Primary outcomes

  1. preoperatively applied Throat lozenges on postoperative Sore Throat,Cough and Hoarseness in patients operated under General Anesthesia

    Time frame: 1, 4, 6, 12, and 24 hours

    postoperatively; sore throat (POST)

Sponsors and collaborators

Lead sponsor

Ankara Medipol University

Other

Registry information

Official study title

The Evaluation of the Effect of Preoperatively Applied Throat Lozenges on Postoperative Sore Throat,Cough and Hoarseness in Patients Operated Under General Anesthesia in Oral and Maxillofacial Surgery Department

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2023
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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