Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia

NCT04000633 | Unknown

• 1 other identifier: lidocaïne cough prevention
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• incidence of sore throat

  24 hours after tracheal extubation

Study Arms (2)

lidocaine group

ACTIVE COMPARATOR

the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia

Drug: Lidocaine 2%

Placebo group

PLACEBO COMPARATOR

the patients of this group will recieve nebulization of 5 ml of normal saline prior to induction of general anesthesia

Drug: Normal saline

Interventions

Lidocaine 2% DRUG

the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia

lidocaine group

Normal saline DRUG

Normal saline

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age\>18 years
• ASA status I or II

You may not qualify if:

• Unexpected difficult laryngoscopy
• Surgery\>3 hours

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Study Sites (1)

Mongi Slim Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

RECRUITING

MeSH Terms

Conditions

Cough; Pharyngitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mhamed Sami Mebazaa, Professor

  Mongi Slim Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mhamed Sami Mebazaa, professor

CONTACT

0021622252589; msmebazaa@gmail.com

Hajer Arfaoui

CONTACT

0021699336661; hejer_arfaoui@hotmail.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The investigator will provide to the anesthesiologist 1 seringue containing either lidocaine or normal saline to be nebulized before induction of general anesthesia
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 2 groups comparaison between nebulized lidocaine versus placebo for prevention of cough at emergence from general anesthesia and post extubation sore throat

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 27, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)