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

NCT ID: NCT02114021

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Sore Throat Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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betamethasone gel

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

Group Type EXPERIMENTAL

betamethasone gel

Intervention Type DRUG

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

distilled water

Intervention Type DRUG

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

lidocaine jelly

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

Group Type EXPERIMENTAL

lidocaine jelly

Intervention Type DRUG

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

distilled water

Intervention Type DRUG

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

distilled water

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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betamethasone gel

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

Intervention Type DRUG

lidocaine jelly

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

Intervention Type DRUG

distilled water

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Islamic Azad University, Sanandaj

OTHER

Sponsor Role collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Fatemeh Shahbazi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology, Booali Hospital, Islamic Azad University,

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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08/13/1019

Identifier Type: -

Identifier Source: org_study_id

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