Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of

Phase 3

Completed

• Conditions: Cough; Sore Throat
• Interventions: Drug: betamethasone gel; Drug: lidocaine jelly; Drug: distilled water

• Registration Number: NCT02114021
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

ABSTRACT:

The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. This study has not been carried out in Iran.

99 patients of either sex undergoing elective surgery were recruited in a single blind randomized study. The patients, using randomization table, were divided into three groups. Anesthetics and medications used during surgery were similar for all the patients.

For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of medications were obtained.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. 50 years<age>15 years
2. no acute upper respiratory infections and no sore throat
3. candidate for elective surgery unrelated to the throat
4. The lack of airways difficulties
5. candidate for general anesthesia with intubation
6. no contraindications for receiving steroid
7. surgery time < 240 minutes
8. intubation up to 2 times
9. tracheal tube cuff pressure = 25-30 cm H2o
10. fasting for 8-6 hours prior to surgery
11. ASA I and ASAII and
12. Surgery under general anesthesia and endotracheal intubation

Exclusion Criteria

1. use of nasogastric tube or throat packs
2. patients with upper respiratory tract infection
3. patients on steroid therapy were excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
betamethasone gel	betamethasone gel	betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
betamethasone gel	distilled water	betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
lidocaine jelly	distilled water	lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
lidocaine jelly	lidocaine jelly	lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

Primary Outcome Measures

Name	Time	Method
sore throat	6 hours after surgery	For the all the patients, the incidence of postoperative cough in 6 hours follow-up based on the different types of medications were obtained (using questionnaire).
cough	24 hours after surgery	For the all the patients, the incidence of postoperative cough in 24 hours follow-up periods based on the different types of medications were obtained (using questionnaire).
hoarseness of voice	24 hours after surgery	For the all patients, the incidence of postoperative hoarseness of the voice in 24 hours follow-up period based on the different types of medications were obtained (using questionnaire).

Trial Locations

Locations (1)

Department of Anesthesiology, Booali Hospital, Islamic Azad University,; 🇮🇷 Tehran, Iran, Islamic Republic of