Effect of Nebulized Lidocaine on Postoperative Sore Throat

Overview

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.

Full Title of Study: “Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 22, 2019

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.

Interventions

  • Other: Saline
    • Effect of saline on postoperative sore throat
  • Other: Lidocaine
    • Effect of nebulized lidocaine on postoperative sore throat

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Changes in the incidence of postoperative sore throat
    • Time Frame: 24 hours
    • 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 Measures

  • whether the hoarseness was present or not
    • Time Frame: 24 hours
    • 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
    • Time Frame: 60 minutes
    • Assessed in intraoperative period
  • Postoperative analgesic consumption
    • Time Frame: 24 hours
    • Assessed in postoperative period
  • Changes in mean arterial pressure
    • Time Frame: 60 minutes
    • Assessed every 5 minutes during the procedure
  • Changes in heart rate
    • Time Frame: 60 minutes
    • Assessed every 5 minutes during the procedure

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Antalya Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ali Sait Kavakli, MD, Principal Investigator, Antalya Training and Research Hospital
    • Hilal Yavuzel, MD, Principal Investigator, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
    • Ulku Arslan, MD, Principal Investigator, Karabuk University Training and Research Hospital

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