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

Not Applicable

Completed

• Conditions: Anesthesia Intubation Complication; Intubation Complication; Sore Throat
• Interventions: Drug: Lidocaine 10% Spray; Drug: Mometasone nasal spray

• Registration Number: NCT04085744
• Lead Sponsor: Derince Training and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-09-07
• Study First Submitted QC: 2019-09-07
• Study First Posted: 2019-09-11
• Study Start: 2019-11-01
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine group	Lidocaine 10% Spray	10% lidocaine spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
steroid group	Mometasone nasal spray	mometasone furoate spray will be applied on the cuff of the intubation tube topically and patient will be intubated.

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) for pain	24 hours	Self reported VAS at postoperative hour 24. VAS 0 is no pain VAS 10 is pain as bad as can be

Trial Locations

Locations (1)

Health and Science University Derince Training and Research Hospital; 🇹🇷 Derince, Kocaeli, Turkey