CoughNCT01715688
Efficacy of Alkalinized Lidocaine in the Endotracheal Tube Cuff on the Incidence of Coughing During Emergence
A study testing Alkalinized lidocaine and Saline in people with Cough and Anesthesia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with alkalinized lidocaine on the: incidence of coughing during emergence of general anesthesia time needed for emergence following a desflurane-based anesthesia incidence of sore throat after extubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough, Anesthesia
- What is being tested?
- Alkalinized lidocaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Apr 2014
- 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
- Patients undergoing elective short-duration surgery under general anesthesia (expected duration of less than 2 hours)
- Physical status 1-3
Who cannot join
- Asthma or severe pulmonary disease
- Pulmonary tract infection
- Anticipated difficult intubation
- Current use of cough medicine
- Contraindication to lidocaine
- Pregnancy
Show all 9Show fewer
- Airway surgery
- Inability to provide informed consent
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2L 4M1
About this study
Official title: Efficacy of Endotracheal Tube Cuffs Pre-filled With Alkalinized Lidocaine Compared to Endotracheal Tube Cuffs Filled With Saline on the Incidence of Coughing During Emergence of Anesthesia.
This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with alkalinized lidocaine on the:
- incidence of coughing during emergence of general anesthesia
- time needed for emergence following a desflurane-based anesthesia
- incidence of sore throat after extubation.
The investigator's hypothesis is that the use of endotracheal tube cuffs pre-filled with alkalinized lidocaine will reduce the incidence of coughing by 50% relative to a control group following a desflurane-based anesthesia.
Read the detailed description
Emergence is an important period of general anesthesia during which several problems can occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence of general anesthesia.
Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has led to earlier discharge and more rapid resumption of normal activities after surgery. However, an incidence of coughing around 70% has been reported after a desflurane-based anesthesia. Different techniques and drugs have been studied to reduce coughing during emergence.
Among others, the role of lidocaine given intravenously, topically, or intracuff has been studied. Intracuff lidocaine has been shown to increase the tolerance to the endotracheal tube without reducing the swallowing reflex. However, lidocaine slowly diffuses across the tube's cuff. The addition of bicarbonates is required to increase its diffusion to the underlying tracheal tissue. Alkalinization of lidocaine allows the diffusion of 65% of its neutral base form over a period of 6 hours.
In vitro studies have demonstrated that the optimal time for local anesthetic diffusion through the cuff may vary from 90 to 180 minutes. Due to its low onset, this technique would be appropriate for long-duration surgeries. Pre-filling the endotracheal tube cuffs with alkalinized lidocaine at least 90 minutes before intubation could be appropriate for surgeries expected to last less than two hours.
This study will assess the efficacy of pre-filling endotracheal tube cuffs with alkalinized lidocaine to prevent coughing during emergence in short-duration surgeries.
- Conditions
- Cough, Anesthesia
- Being tested
- Alkalinized lidocaine, Saline
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkalinized lidocaineDrug
Administration of alkalinized lidocaine in the endotracheal tube cuff
SalineDrug
Administration of saline in the endotracheal tube cuff
| Study group | Role | What they receive |
|---|---|---|
| Alkalinized lidocaine | Active comparator | The endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with alkalinized lidocaine. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube).
During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist. Receives: Drug: Alkalinized lidocaine |
| Saline | Placebo comparator | The endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with saline. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube).
During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coughing during emergence of general anesthesia
Measured: At extubation (Day 0)
Secondary outcomes (2)
Time to emergence
Measured: At extubation (Day 0)
Incidence of sore throat
Measured: One hour after extubation (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Nathalie Massicotte, MD, FRCPC, Principal investigator, Centre Hospitalier de l'Université de Monrtréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715688
- Sponsor's protocol ID
- NM2012-003
- Status last verified
- Jan 2016
- First submitted
- 25 Oct 2012
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nath P, Williams S, Herrera Mendez LF, Massicotte N, Girard F, Ruel M. Alkalinized Lidocaine Preloaded Endotracheal Tube Cuffs Reduce Emergence Cough After Brief Surgery: A Prospective Randomized Trial. Anesth Analg. 2018 Feb;126(2):615-620. doi: 10.1213/ANE.0000000000002647.
PubMed 29189279
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Endotracheal Tube Cuffs Pre-filled With Alkalinized Lidocaine Compared to Endotracheal Tube Cuffs Filled With Saline on the Incidence of Coughing During Emergence of Anesthesia.
- ClinicalTrials.gov ID
- NCT01715688
- Acronym / sponsor ID
- NM2012-003
- Conditions
- Cough, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Oct 2012 (estimated)
- 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.
This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with alkalinized lidocaine on the:
- incidence of coughing during emergence of general anesthesia
- time needed for emergence following a desflurane-based anesthesia
- incidence of sore throat after extubation.
The investigator's hypothesis is that the use of endotracheal tube cuffs pre-filled with alkalinized lidocaine will reduce the incidence of coughing by 50% relative to a control group following a desflurane-based anesthesia.
Detailed description
Emergence is an important period of general anesthesia during which several problems can occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence of general anesthesia.
Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has led to earlier discharge and more rapid resumption of normal activities after surgery. However, an incidence of coughing around 70% has been reported after a desflurane-based anesthesia. Different techniques and drugs have been studied to reduce coughing during emergence.
Among others, the role of lidocaine given intravenously, topically, or intracuff has been studied. Intracuff lidocaine has been shown to increase the tolerance to the endotracheal tube without reducing the swallowing reflex. However, lidocaine slowly diffuses across the tube's cuff. The addition of bicarbonates is required to increase its diffusion to the underlying tracheal tissue. Alkalinization of lidocaine allows the diffusion of 65% of its neutral base form over a period of 6 hours.
In vitro studies have demonstrated that the optimal time for local anesthetic diffusion through the cuff may vary from 90 to 180 minutes. Due to its low onset, this technique would be appropriate for long-duration surgeries. Pre-filling the endotracheal tube cuffs with alkalinized lidocaine at least 90 minutes before intubation could be appropriate for surgeries expected to last less than two hours.
This study will assess the efficacy of pre-filling endotracheal tube cuffs with alkalinized lidocaine to prevent coughing during emergence in short-duration surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alkalinized lidocaine | Active comparator | Drug: Alkalinized lidocaineThe endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with alkalinized lidocaine. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube). During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist. |
| Saline | Placebo comparator | Drug: SalineThe endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with saline. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube). During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective short-duration surgery under general anesthesia (expected duration of less than 2 hours)
- Physical status 1-3
Key exclusion criteria (9 listed)
- Asthma or severe pulmonary disease
- Pulmonary tract infection
- Anticipated difficult intubation
- Current use of cough medicine
- Contraindication to lidocaine
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 |
|---|---|---|
| Alkalinized lidocaineAdministration of alkalinized lidocaine in the endotracheal tube cuff | Drug | Alkalinized lidocaine |
| SalineAdministration of saline in the endotracheal tube cuff | Drug | Saline |
Primary outcome
Incidence of coughing during emergence of general anesthesia
Time frame: At extubation (Day 0)
2 secondary outcomes
Time to emergence
Time frame: At extubation (Day 0)
Incidence of sore throat
Time frame: One hour after extubation (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Derived from this study: PubMed 29189279Nath P, Williams S, Herrera Mendez LF, Massicotte N, Girard F, Ruel M. Alkalinized Lidocaine Preloaded Endotracheal Tube Cuffs Reduce Emergence Cough After Brief Surgery: A Prospective Randomized Trial. Anesth Analg. 2018 Feb;126(2):615-620. doi: 10.1213/ANE.0000000000002647.
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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.
Nathalie Massicotte, MD, FRCPC principal investigator
Centre Hospitalier de l'Université de Monrtréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alkalinized lidocaine and Saline in people with Cough and Anesthesia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 9 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: finished, as of the sponsor's last update on 1 Feb 2016. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of coughing during emergence of general anesthesia (time frame: At extubation (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715688, which also lists 1 linked publication.
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 1 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.