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Effect of Nebulized Lidocaine on Postoperative Sore Throat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03779516
Recruitment Status : Terminated (change in procedure)
First Posted : December 19, 2018
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Antalya Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Sore Throat Other: Saline Other: Lidocaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation
Actual Study Start Date : December 19, 2018
Actual Primary Completion Date : April 22, 2019
Actual Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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".

  2. Intraoperative opioid consumption [ Time Frame: 60 minutes ]
    Assessed in intraoperative period

  3. Postoperative analgesic consumption [ Time Frame: 24 hours ]
    Assessed in postoperative period

  4. Changes in mean arterial pressure [ Time Frame: 60 minutes ]
    Assessed every 5 minutes during the procedure

  5. Changes in heart rate [ Time Frame: 60 minutes ]
    Assessed every 5 minutes during the procedure



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779516


Locations
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Turkey
Antalya Training and Research Hospital
Antalya, Turkey
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
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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
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Responsible Party: Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03779516    
Other Study ID Numbers: AntalyaTRH 28
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: December 2018

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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
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action