An Approach to Reduce Uvula Edema After Tonsillectomy

NCT ID: NCT03079453

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-15
• Study Completion Date: 2019-04-10

Brief Summary

A prospective randomized clinical trial that included thirty subjects who underwent tonsillectomy. The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly before tonsillectomy. Group 2 (n:15) patients had tonsillectomy without dexamethasone injection. Patients were examined preoperatively and postoperative on the first and fifth days. In this study investigators tried an approach of dexamethasone application to reduce uvula edema after tonsillectomy.

Detailed Description

Thirty patients between the ages of 18 and 48 years were enrolled in this prospective randomized clinical trial from July 2015 to July 2016. The study was carried out in a tertiary referral center in Istanbul, Turkey. Permission for the study was obtained from Bezmialem Vakif University Clinical Research Ethics Committee, on 03 June 2015, number11/18.

The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly at three points (three points on the connection of the uvula, and palatum molle) before tonsillectomy. Group 2 (n:15) patients had tonsillectomy without dexamethasone injection. All patients had the operation under general anesthesia by utilizing the same protocol. Both of the groups were not given iv/im dexamethasone perioperatively. The surgical technique for tonsillectomy was bipolar cautery dissection performed by the same surgeon. The oropharyngeal area was examined and photographed endoscopically preoperatively and postoperative on the first and fifth days. All of the participants were examined with an 8mm diameter 70º endoscope. The photographs of the oropharynx (anterior plicas, tonsils, uvula, posterior oropharynx) were taken by holding the endoscope positioned vertically to the mouth. Blinded observers made examinations of the groups at the postoperative first and fifth days and evaluated the uvula edema by using the uvula edema scale that the investigators developed.

The investigators used a scale for grading uvula edema. There is no such scale in the English literature so the investigators developed a scale for grading uvula edema. The investigators grade edema from 1 to 5 as an increase of the edema area. It is called Grade 1 if there was elongation only at the tip of the uvula. If there was edema in the body and base of the uvula, it is called Grade 2. If the uvula edema was spread over a larger area than Grade 2, and if there was involvement in the unilateral plica, it is called Grade 3. If it was spread to both pharyngeal plicas, it is called grade 4. If the uvula edema caused the complete blockage of the posterior pharyngeal tract, it is called Grade 5.

The statistical tests were conducted using the Statistical Package for the Social Sciences version 24.0 for Windows (SPSS Inc., Chicago, Illinois, USA). All quantitative variables were estimated using measures of central location (i.e., mean and median) and measures of dispersion (i.e., standard deviation [SD]). Data normality was tested using the Shapiro-Wilk tests of normality. Descriptive statistical analysis were made. Paired t test was used for comparison of intra-group quantitative data. Independent t test was used to compare groups of quantitative data.

Conditions

Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 1

The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly at three points (three points on the connection of the uvula, and palatum molle) before tonsillectomy .

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

The patients in Group 1 were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly before tonsillectomy

Group 2

Group 2 (n:15) patients had tonsillectomy without dexamethasone injection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexamethasone

The patients in Group 1 were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly before tonsillectomy

Intervention Type: DRUG

Other Intervention Names

Dexasone

Eligibility Criteria

Inclusion Criteria

• Subjects with recurrent tonsillitis but no sleep apnea
• Subjects older than eighteen years old
• Subjects were planned to have only tonsillectomy procedure

Exclusion Criteria

• Subjects who must have additional procedures other than tonsillectomy
• Subjects younger than eighteen years old
• Subjects that had intravenous dexamethasone administration perioperatively

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Nazan Degirmenci

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selahattin Tugrul, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

11/18-03.06.2015

Identifier Type: -

Identifier Source: org_study_id