Effect of Nebulized Lidocaine on Postoperative Sore Throat

NCT ID: NCT03779516

Last Updated: 2020-04-30

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

TERMINATED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2019-07-15

Brief Summary

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The purpose of this study is to test the hypothesis that use of preoperative nebulized lidocaine is reduced the incidence of postoperative sore throat after endotracheal intubation.

Detailed Description

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Adult patients undergoing video-assisted thoracic surgery (VATS) requiring double lumen tube (DLT) endotracheal intubation for one-lung ventilation (OLV) were enrolled in the study. Patients were randomized by means of computer-generated order randomization into two groups: Group C (those who received a saline solution as placebo delivered by nebulization) and Group L (those who received lidocaine delivered by nebulization).

At 1, 6 and 24 h after tracheal extubation, an observer blinded to treatments evaluated the patients in terms of sore throat and hoarseness. In addition, Patients' satisfaction, intraoperative and postoperative opioid and analgesics consumption and complaints such as dysphagia, nausea and vomiting were recorded. Hemodynamic variables such as blood pressure and heart rate were also recorded.

Conditions

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Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group C

In Control Group, 4 mL of saline solution was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type OTHER

Effect of saline on postoperative sore throat

Group L

In Lidocaine Group 4 mL of 4% lidocaine was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type OTHER

Effect of nebulized lidocaine on postoperative sore throat

Interventions

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Saline

Effect of saline on postoperative sore throat

Intervention Type OTHER

Lidocaine

Effect of nebulized lidocaine on postoperative sore throat

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients undergoing video-assisted thoracic surgery requiring double lumen tube endotracheal intubation for one-lung ventilation
* American Society of Anesthesiologists class 1,2 and 3
* Ability to consent

Exclusion Criteria

* patients \<18 years old
* body mass index (BMI) \<20 or \>35 kg/m2
* Mallampati grade 3 or 4
* mouth opening \< 3 cm
* preexisting hoarseness or sore throat
* coagulopathy
* patient with upper respiratory tract infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Sait Kavakli, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Hilal Yavuzel, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Ulku Arslan, MD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University Training and Research Hospital

Locations

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Antalya Training and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AntalyaTRH 28

Identifier Type: -

Identifier Source: org_study_id

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