The Evaluation of the Effect of Preoperatively Applied Throat Lozenge

NCT06114771 | Completed

• 1 other identifier: Ank-Medipol-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Pain, Postoperative

Keywords

Pain; Anesthesia and Analgesia; Orthognathic Surgery

Outcome Measures

Primary Outcomes (1)

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

  postoperatively; sore throat (POST)

  1, 4, 6, 12, and 24 hours

Study Arms (2)

orthognathic surgery patients / lozange

ACTIVE COMPARATOR

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

Other: strepsilis

orthognathic surgery patients / candy

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

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).

orthognathic surgery patients / lozange

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.

orthognathic surgery patients / candy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Medipol University: lead

Study Sites (1)

Raha

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• mine CAMBAZOĞLU, Prof

  Ankara University faculity of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 2, 2023
• Study Start: March 3, 2021
• Primary Completion: May 5, 2022
• Study Completion: August 6, 2022
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)