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Status unknownNCT04000633Updated Jun 27, 2019

Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia

An interventional study of Lidocaine 2% and Normal saline in Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat, sponsored by Mongi Slim Hospital. Status unknown at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-27.

Sponsored by Mongi Slim Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat

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03

In context

Cough

355 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's planned enrollment of 80 is above the median of 71 across 270 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Mongi Slim Hospital is the lead sponsor of 38 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age>18 years
  • ASA status I or II

Exclusion criteria

Exclusion Criteria:

  • Unexpected difficult laryngoscopy
  • Surgery>3 hours
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
80 participants (estimated)

Study arms

  • 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%

  • 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

Interventions

  • DrugLidocaine 2%

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

  • DrugNormal saline

    Normal saline

06

What researchers measure

Primary outcomes

  1. incidence of cough at emergence from general anesthesia

    evaluation of incidence of cough at emergence from general anesthesia

    Time frame: 30 minutes after the end of surgery

Secondary outcomes

  1. incidence of sore throat

    evaluation of incidence of sore throat

    Time frame: 24 hours after tracheal extubation

07

Study locations

1 of 1 sites recruiting
  • Mongi Slim Hospital
    La Marsa, Tunis Governorate 2046, Tunisia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2019 (actual). Primary completion is estimated for Dec 2019, 6 months after the start.

Of 66 non-industry interventional studies with no phase under Cough, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 6 months is below that.

Counting every sponsor, half of 71 studies reached it within 15 months; a quarter within 8 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2019
First posted
Jun 27, 2019
StartActual
Jun 1, 2019
Primary completionEst.
Dec 31, 2019
CompletionEst.
Dec 31, 2019
Last update
Jun 27, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04000633
Lead sponsor
Mongi Slim Hospital
Responsible party
Mhamed Sami Mebazaa (professor, Mongi Slim Hospital) — Principal investigator
First posted
Jun 27, 2019
Start date
Jun 1, 2019
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Jun 27, 2019

Study contacts

Mhamed Sami Mebazaa, professor
Contact
msmebazaa@gmail.com
0021622252589
Hajer Arfaoui
Contact
hejer_arfaoui@hotmail.fr
0021699336661
Mhamed Sami Mebazaa, Professor
principal investigator · Mongi Slim Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Lidocaine

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