Effect of Nebulized Lidocaine on Postoperative Sore Throat

Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation

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.

Study Overview

• Status: Terminated
• Conditions: Sore Throat
• Intervention / Treatment: Other: Saline; Other: Lidocaine

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Antalya Training And Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Saline; Effect of saline on postoperative sore throat
Active Comparator: 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	Other: Lidocaine; Effect of nebulized lidocaine on postoperative sore throat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mean arterial pressure	Assessed every 5 minutes during the procedure	60 minutes
Changes in heart rate	Assessed every 5 minutes during the procedure	60 minutes
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".	24 hours
Intraoperative opioid consumption	Assessed in intraoperative period	60 minutes
Postoperative analgesic consumption	Assessed in postoperative period	24 hours

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Principal Investigator: Ali Sait Kavakli, MD, Antalya Training And Research Hospital; Principal Investigator: Hilal Yavuzel, MD, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital; Principal Investigator: Ulku Arslan, MD, Karabuk University Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2018
• Primary Completion (Actual): April 22, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: AntalyaTRH 28

Drug and device information, study documents

• 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