Postoperative Sore ThroatELITNCT03792776
Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough
A study testing cuff inflation with air, cuff inflation with lidocaine 1% and cuff inflation with lidocaine 2% in people with Postoperative Sore Throat and Postoperative Cough, run by Ogarite Habib.
Trial summary
Comparing the effect of different methods of endotracheal tube cuff inflation on the occurrence of a postoperative sore throat and cough (Air vs Lidocaine 1% vs Lidocaine 2%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Sore Throat, Postoperative Cough
- What is being tested?
- cuff inflation with air, cuff inflation with lidocaine 1% and cuff inflation with lidocaine 2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Oct 2020
- 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 over 18 years old
- American Society of Anesthesiologists classification (ASA) category 1 or 2
- High pressure, low volume endotracheal tube - (Lo-pro)
Who cannot join
- Ear nose and throat and cranial surgery
- Ear nose and throat pathologies
- Asthma and bronchial hyperreactivity
- Chronic cough
- Diabetes
- Cognitive disorders
Show all 14Show fewer
- Swallowing disorders
- Corticotherapy during the last week
- Allergy to lidocaine
- Urgent surgery
- Nasogastric, oro-gastric
- Ventral position
- More than 2 intubation attempts
- Continuous intravenous infusion of lidocaine intraoperatively.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Lidocaine 1% and 2% in the Endotracheal Tube Cuff on Postoperative Sore Throat and Cough
Comparing the effect of different methods of endotracheal tube cuff inflation on the occurrence of a postoperative sore throat and cough (Air vs Lidocaine 1% vs Lidocaine 2%).
Read the detailed description
Eligible patients undergoing general anesthesia will be randomized and assigned to three groups:
Group A: Endotracheal tube cuff inflation with air Group B: Endotracheal tube cuff inflation with Lidocaine 1% Group C: Endotracheal tube cuff inflation with Lidocaine 2%
The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.
Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).
The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).
The volume of lidocaine used will never exceed 5 mg / kg for the patient to be protected from the local toxicity of the local anesthetic in case of accidental rupture of the balloon.
All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.
- Conditions
- Postoperative Sore Throat, Postoperative Cough
- Being tested
- cuff inflation with air, cuff inflation with lidocaine 1%, cuff inflation with lidocaine 2%, Induction of anesthesia, Maintenance of anesthesia
- Keywords
- Lidocaine 1%, Lidocaine 2%, Endotracheal tube cuff, Cuff inflation, Postoperative sore throat, Postoperative cough, General anesthesia, Endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cuff inflation with airOther
Endotracheal tube cuff inflation with air
cuff inflation with lidocaine 1%Drug
Endotracheal tube cuff inflation with lidocaine 1%
cuff inflation with lidocaine 2%Drug
Endotracheal tube cuff inflation with lidocaine 2%
Induction of anesthesiaOther
The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.
Maintenance of anesthesiaOther
Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).
Endotracheal intubationOther
The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).
Systematic post-operative analgesiaOther
All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Air | Active comparator | Endotracheal tube cuff inflation with air Receives: Other: cuff inflation with air; Other: Induction of anesthesia; Other: Maintenance of anesthesia; Other: Endotracheal intubation; Other: Systematic post-operative analgesia |
| Lidocaine 1% | Experimental | Endotracheal tube cuff inflation with Lidocaine 1% Receives: Drug: cuff inflation with lidocaine 1%; Other: Induction of anesthesia; Other: Maintenance of anesthesia; Other: Endotracheal intubation; Other: Systematic post-operative analgesia |
| Lidocaine 2% | Experimental | Endotracheal tube cuff inflation with Lidocaine 2% Receives: Drug: cuff inflation with lidocaine 2%; Other: Induction of anesthesia; Other: Maintenance of anesthesia; Other: Endotracheal intubation; Other: Systematic post-operative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sore throat intensity 0
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Measured: hour 0 after extubation
Sore throat intensity 2
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Measured: at 2 hours after extubation
Sore throat intensity 6
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Measured: at 6 hours after extubation
Sore throat intensity 24
Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))
Measured: at 24 hours after extubation
Cough intensity 0
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Measured: hour 0 after extubation
Cough intensity 2
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Measured: at 2 hours after extubation
Cough intensity 6
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Measured: at 6 hours after extubation
Cough intensity 24
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Measured: at 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ogarite Habib
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ogarite Habib, Saint-Joseph University
- Investigators
- Hicham Jabbour, MD, Study director, Saint JU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792776
- Sponsor's protocol ID
- CEHDF 1263
- Acronym
- ELIT
- Status last verified
- Jan 2019
- First submitted
- 22 Dec 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine 1% and 2% in the Endotracheal Tube Cuff on Postoperative Sore Throat and Cough
- ClinicalTrials.gov ID
- NCT03792776
- Acronym / sponsor ID
- ELIT / CEHDF 1263
- Conditions
- Postoperative Sore Throat, Postoperative Cough
- Keywords
- Lidocaine 1%, Lidocaine 2%, Endotracheal tube cuff, Cuff inflation, Postoperative sore throat, Postoperative cough, General anesthesia, Endotracheal intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ogarite HabibUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 3 Jan 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.
Comparing the effect of different methods of endotracheal tube cuff inflation on the occurrence of a postoperative sore throat and cough (Air vs Lidocaine 1% vs Lidocaine 2%).
Detailed description
Eligible patients undergoing general anesthesia will be randomized and assigned to three groups:
Group A: Endotracheal tube cuff inflation with air Group B: Endotracheal tube cuff inflation with Lidocaine 1% Group C: Endotracheal tube cuff inflation with Lidocaine 2%
The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.
Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).
The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).
The volume of lidocaine used will never exceed 5 mg / kg for the patient to be protected from the local toxicity of the local anesthetic in case of accidental rupture of the balloon.
All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Air | Active comparator | Other: cuff inflation with air, Other: Induction of anesthesia, Other: Maintenance of anesthesia, Other: Endotracheal intubation, Other: Systematic post-operative analgesiaEndotracheal tube cuff inflation with air |
| Lidocaine 1% | Experimental | Drug: cuff inflation with lidocaine 1%, Other: Induction of anesthesia, Other: Maintenance of anesthesia, Other: Endotracheal intubation, Other: Systematic post-operative analgesiaEndotracheal tube cuff inflation with Lidocaine 1% |
| Lidocaine 2% | Experimental | Drug: cuff inflation with lidocaine 2%, Other: Induction of anesthesia, Other: Maintenance of anesthesia, Other: Endotracheal intubation, Other: Systematic post-operative analgesiaEndotracheal tube cuff inflation with Lidocaine 2% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years old
- American Society of Anesthesiologists classification (ASA) category 1 or 2
- High pressure, low volume endotracheal tube - (Lo-pro)
Key exclusion criteria (14 listed)
- Ear nose and throat and cranial surgery
- Ear nose and throat pathologies
- Asthma and bronchial hyperreactivity
- Chronic cough
- Diabetes
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 |
|---|---|---|
| cuff inflation with airEndotracheal tube cuff inflation with air | Other | Air |
| cuff inflation with lidocaine 1%Endotracheal tube cuff inflation with lidocaine 1% | Drug | Lidocaine 1% |
| cuff inflation with lidocaine 2%Endotracheal tube cuff inflation with lidocaine 2% | Drug | Lidocaine 2% |
| Induction of anesthesiaThe induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg. | Other | Air, Lidocaine 1%, Lidocaine 2% |
| Maintenance of anesthesiaMaintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention). | Other | Air, Lidocaine 1%, Lidocaine 2% |
| Endotracheal intubationThe intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O). | Other | Air, Lidocaine 1%, Lidocaine 2% |
| Systematic post-operative analgesiaAll patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery. | Other | Air, Lidocaine 1%, Lidocaine 2% |
Primary outcome
Sore throat intensity 0
Time frame: hour 0 after extubation
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Sore throat intensity 2
Time frame: at 2 hours after extubation
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Sore throat intensity 6
Time frame: at 6 hours after extubation
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Sore throat intensity 24
Time frame: at 24 hours after extubation
Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))
Cough intensity 0
Time frame: hour 0 after extubation
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 2
Time frame: at 2 hours after extubation
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 6
Time frame: at 6 hours after extubation
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 24
Time frame: at 24 hours after extubation
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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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.
Hicham Jabbour, MD study director
Saint JU
Questions about this trial
What is this clinical trial studying?
A study testing cuff inflation with air, cuff inflation with lidocaine 1% and cuff inflation with lidocaine 2% in people with Postoperative Sore Throat and Postoperative Cough, run by Ogarite Habib.
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 3 inclusion and 14 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Ogarite P Habib, MD (+9613722518, Ogarite.habib@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sore throat intensity 0 (time frame: hour 0 after extubation). The study lists 8 primary outcomes in all. 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 15 Jan 2019.