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Effect of Nebulized Lidocaine on Postoperative Sore Throat

Primary Purpose

Sore Throat

Status
Terminated
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Saline
Lidocaine
Sponsored by
Antalya Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sore Throat

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Antalya Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group C

Group L

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in the incidence of postoperative sore throat
Sore throat was assessed using a 0-100 mm visual analog scale (VAS), where a score of 0 represents no pain and a score of 100 reflects the worst pain imaginable.

Secondary Outcome Measures

whether the hoarseness was present or not
Hoarseness was defined as a change in voice quality and it was assessed by the patients themselves. The change in voice quality at any time during the observation period was defined as "hoarseness was present".
Intraoperative opioid consumption
Assessed in intraoperative period
Postoperative analgesic consumption
Assessed in postoperative period
Changes in mean arterial pressure
Assessed every 5 minutes during the procedure
Changes in heart rate
Assessed every 5 minutes during the procedure

Full Information

First Posted
December 17, 2018
Last Updated
April 28, 2020
Sponsor
Antalya Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03779516
Brief Title
Effect of Nebulized Lidocaine on Postoperative Sore Throat
Official Title
Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
change in procedure
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
April 22, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antalya Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Active Comparator
Arm Description
In Control Group, 4 mL of saline solution was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min
Arm Title
Group L
Arm Type
Active Comparator
Arm Description
In Lidocaine Group 4 mL of 4% lidocaine was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Effect of saline on postoperative sore throat
Intervention Type
Other
Intervention Name(s)
Lidocaine
Intervention Description
Effect of nebulized lidocaine on postoperative sore throat
Primary Outcome Measure Information:
Title
Changes in the incidence of postoperative sore throat
Description
Sore throat was assessed using a 0-100 mm visual analog scale (VAS), where a score of 0 represents no pain and a score of 100 reflects the worst pain imaginable.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
whether the hoarseness was present or not
Description
Hoarseness was defined as a change in voice quality and it was assessed by the patients themselves. The change in voice quality at any time during the observation period was defined as "hoarseness was present".
Time Frame
24 hours
Title
Intraoperative opioid consumption
Description
Assessed in intraoperative period
Time Frame
60 minutes
Title
Postoperative analgesic consumption
Description
Assessed in postoperative period
Time Frame
24 hours
Title
Changes in mean arterial pressure
Description
Assessed every 5 minutes during the procedure
Time Frame
60 minutes
Title
Changes in heart rate
Description
Assessed every 5 minutes during the procedure
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Sait Kavakli, MD
Organizational Affiliation
Antalya Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hilal Yavuzel, MD
Organizational Affiliation
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulku Arslan, MD
Organizational Affiliation
Karabuk University Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Research Hospital
City
Antalya
Country
Turkey

12. IPD Sharing Statement

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Effect of Nebulized Lidocaine on Postoperative Sore Throat

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