Cough, General Anesthesia, Extubation, Lidocaine, Sore ThroatNCT04000633
Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia
A study testing Lidocaine 2% and Normal saline in people with Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat
- What is being tested?
- Lidocaine 2% and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jun 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>18 years
- ASA status I or II
Who cannot join
- Unexpected difficult laryngoscopy
- Surgery>3 hours
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Mongi Slim Hospital
La Marsa, Tunis Governorate, 2046
Mhamed Sami Mebazaa, professor, 0021622252589, msmebazaa@gmail.com
Asma Ben Souissi, Ass Prof, 0021698336883, bsouissiasma@gmail.com
About this study
Official title: 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.
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.
- Being tested
- Lidocaine 2%, Normal saline
- Medical subject headings
- Cough, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2%Drug
the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia
Normal salineDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| lidocaine group | Active comparator | the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia Receives: 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 Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of cough at emergence from general anesthesia
evaluation of incidence of cough at emergence from general anesthesia
Measured: 30 minutes after the end of surgery
Secondary outcomes (1)
incidence of sore throat
evaluation of incidence of sore throat
Measured: 24 hours after tracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Jun 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cough, General Anesthesia, Extubation, Lidocaine, Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups comparaison between nebulized lidocaine versus placebo for prevention of cough at emergence from general anesthesia and post extubation sore throat
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
- Investigators
- Mhamed Sami Mebazaa, Professor, Principal investigator, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000633
- Sponsor's protocol ID
- lidocaïne cough prevention
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Lidocaine Versus Placebo to Prevent Cough at Emergence From Anesthesia: a Double Blind Prospective Randomised Trial
- ClinicalTrials.gov ID
- NCT04000633
- Acronym / sponsor ID
- lidocaïne cough prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 2 groups comparaison between nebulized lidocaine versus placebo for prevention of cough at emergence from general anesthesia and post extubation sore throat
| Arm | Type | Receives |
|---|---|---|
| lidocaine group | Active comparator | Drug: Lidocaine 2%the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia |
| Placebo group | Placebo comparator | Drug: Normal salinethe patients of this group will recieve nebulization of 5 ml of normal saline prior to induction of general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age>18 years
- ASA status I or II
Key exclusion criteria (2 listed)
- Unexpected difficult laryngoscopy
- Surgery>3 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 2%the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia | Drug | lidocaine group |
| Normal salineNormal saline | Drug | Placebo group |
Primary outcome
incidence of cough at emergence from general anesthesia
Time frame: 30 minutes after the end of surgery
evaluation of incidence of cough at emergence from general anesthesia
1 secondary outcome
incidence of sore throat
Time frame: 24 hours after tracheal extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mhamed Sami Mebazaa, Professor principal investigator
Mongi Slim Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 2% and Normal saline in people with Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat, run by Mongi Slim Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mhamed Sami Mebazaa, professor (0021622252589, msmebazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of cough at emergence from general anesthesia (time frame: 30 minutes after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.