A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff

NCT ID: NCT04085744

Last Updated: 2023-11-18

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

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-06-15

Brief Summary

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This study aims to compare effects of two different agents on complications due to tracheal tube cuff in pediatric patients. Sore throat, hoarseness, laryngospasm, bronchospasm are the main complications.

Detailed Description

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In the literature there were studies about both local anesthetic agents and topical steroids and different densities of saline which were applied to decrease airway complications. In this study researchers intended to compare effects of local anesthetic agents and topical steroids applying around tracheal tube on airway complications which may occur in the first 24 hours after surgery. All pediatric patients scheduled for elective surgery will be recruited. enrolled patients will randomly assigned in to three groups: Control group, local anesthetic group and topical steroid group.

Conditions

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Anesthesia Intubation Complication Intubation Complication Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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control group

In this group any drug will be applied on the cuff of the intubation tube

Group Type NO_INTERVENTION

No interventions assigned to this group

lidocaine group

10% lidocaine spray will be applied on the cuff of the intubation tube topically and patient will be intubated.

Group Type ACTIVE_COMPARATOR

Lidocaine 10% Spray

Intervention Type DRUG

lidocaine will be apply on the cuff

steroid group

mometasone furoate spray will be applied on the cuff of the intubation tube topically and patient will be intubated.

Group Type ACTIVE_COMPARATOR

Mometasone nasal spray

Intervention Type DRUG

mometasone spray will be applied on the cuff

Interventions

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Lidocaine 10% Spray

lidocaine will be apply on the cuff

Intervention Type DRUG

Mometasone nasal spray

mometasone spray will be applied on the cuff

Intervention Type DRUG

Other Intervention Names

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lidocaine steroid

Eligibility Criteria

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Inclusion Criteria

* Being ages between 2 and 18
* undergoing elective surgery
* intubated patients over 1 hour
* ASA(American Society of Anesthesiologists) Class I-II patients

Exclusion Criteria

* Urgent surgeries
* Tonsillectomies, adenoidectomies ..etc, operations that causes sore throat due to the operation area.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Derince Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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ALI ULVI OLC

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse Z Turan

Role: STUDY_DIRECTOR

HEALTH AND SCİENCE UNIVERSITY DERINCE TRAINING AND RESEARCH HOSPITAL

Locations

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Health and Science University Derince Training and Research Hospital

Derince, Kocaeli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AOLC-1

Identifier Type: -

Identifier Source: org_study_id

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