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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Cough; Sore Throat

Treatments: Drug: lidocaine jelly; Drug: betamethasone gel; Drug: distilled water

Study type: Interventional

Funder types: Other

Identifiers

NCT02114021

08/13/1019

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 3 patient groups, including a placebo group

betamethasone gel

Experimental group

Description:

betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

Treatment:

Drug: betamethasone gel

Drug: distilled water

lidocaine jelly

Experimental group

Description:

lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

Treatment:

Drug: lidocaine jelly

Drug: distilled water

distilled water

Placebo Comparator group

Description:

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