Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia

Nebulized Lidocaine Versus Placebo to Prevent Cough at Emergence From Anesthesia: a Double Blind Prospective Randomised Trial

our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

Study Overview

• Status: Unknown
• Conditions: Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat
• Intervention / Treatment: Drug: Normal saline; Drug: Lidocaine 2%

Detailed Description

our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

This randomized controlled study will compare the effect of Lidocaine and placebo nebulization in the immediate pre operative period in order to evaluate the effectiveness in reducing post extubation cough and sore throat.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hajer Arfaoui; Phone Number: 0021699336661; Email: hejer_arfaoui@hotmail.fr

Study Locations

• Tunisia
  • Tunis
    • La Marsa, Tunis, Tunisia, 2046
      • Recruiting
      • Mongi Slim hospital
      • Contact: Asma Ben Souissi, Ass Prof; Phone Number: 0021698336883; Email: bsouissiasma@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age>18 years
• ASA status I or II

Exclusion Criteria:

• Unexpected difficult laryngoscopy
• Surgery>3 hours

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lidocaine group; the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia	Drug: Lidocaine 2%; the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia
Placebo Comparator: Placebo group; the patients of this group will recieve nebulization of 5 ml of normal saline prior to induction of general anesthesia	Drug: Normal saline; Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of cough at emergence from general anesthesia	evaluation of incidence of cough at emergence from general anesthesia	30 minutes after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of sore throat	evaluation of incidence of sore throat	24 hours after tracheal extubation

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital
• Investigators: Principal Investigator: Mhamed Sami Mebazaa, Professor, Mongi Slim hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Cough; 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: lidocaïne cough prevention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No