The Evaluation of the Effect of Preoperatively Applied Throat Lozenge

• Sponsor: Ankara Medipol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06114771
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.1
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Pain, Postoperative	Other: strepsilis; Other: Placebo	N/A

Detailed Description

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official 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
• Actual Study Start Date: Mar 3, 2021
• Actual Primary Completion Date: May 5, 2022
• Actual Study Completion Date: Aug 6, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: orthognathic surgery patients / lozange 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; 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 Comparator: orthognathic surgery patients / candy 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; 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.

Outcome Measures

Primary Outcome Measures

1. preoperatively applied Throat lozenges on postoperative Sore Throat,Cough and Hoarseness in patients operated under General Anesthesia [1, 4, 6, 12, and 24 hours]

   postoperatively; sore throat (POST)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Raha	Ankara		Turkey

Sponsors and Collaborators

• Ankara Medipol University

Investigators

• Study Director: mine CAMBAZOĞLU, Prof, Ankara University faculity of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raha Akbarihamed, lecturer, Ankara Medipol University
• ClinicalTrials.gov Identifier: NCT06114771
• Other Study ID Numbers: Ank-Medipol-01
• First Posted: Nov 2, 2023
• Last Update Posted: Nov 2, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Raha Akbarihamed, lecturer, Ankara Medipol University: Pain; Anesthesia and Analgesia; Orthognathic Surgery
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Nov 2, 2023