Sore ThroatNCT01838993
Inhalation of Lidocaine Before Intubation
A study testing Lidocaine inhalation in people with Sore Throat, run by New Taipei City Hospital at 1 site in Taiwan.
Trial summary
We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sore Throat
- What is being tested?
- Lidocaine inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to May 2013
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II. Patients scheduled for elective surgery under general anesthesia with orotracheal intubation
Who cannot join
- patient's refusal to join, major surgery or expected operation duration longer than 3 hours, patients with a anticipated difficult airway, requiring a nasogastric tube in peri-operative stage, having recent upper respiratory tract infection (within 1 week) or pre-existing sore throat.
Trial locations and contacts
1 site in 1 country.
Chen Yen Po, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
New Taipei City Hospital
New Taipei City
Lin Chi-Hsuan, MD, ad2354@ntpc.gov.tw
About this study
Official title: The Effect of Ultrasonic Nebulizer Delivered Lidocaine on Circulatory Responses During Tracheal Intubation and Postoperative Sore Throat
We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction.
Read the detailed description
Sudden increases in blood pressure and heart rate after tracheal intubation and post-operative sore throat are two common undesirable side effects of general anesthesia and might lead to patients' morbidity or dissatisfaction. We investigated the possibility to attenuate both side effects with one single method, i.e. ultrasound-driven lidocaine inhalation immediately before induction.
- Conditions
- Sore Throat
- Being tested
- Lidocaine inhalation, Placebo
- Keywords
- anesthetics,, local,, lidocaine;, nebulizers and vaporizers;, complications,, intubation,, intratracheal.
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine inhalationDrug
Lidocaine inhalation before intubation
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Inhalation of lidocaine before intubation Receives: Drug: Lidocaine inhalation |
| Control | Placebo comparator | Normal saline inhalation before intubation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Non invasive blood pressure every min for 3 min
Measured: 3 min
Secondary outcomes (1)
Post operative sore throat
Questionnaire for Post operative sore throat
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Taipei City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Yen-Po, New Taipei City Hospital
- Investigators
- Chen Yen Po, MD, Principal investigator, New Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838993
- Sponsor's protocol ID
- CS 2013011
- Status last verified
- Apr 2013
- First submitted
- 21 Apr 2013
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasonic Nebulizer Delivered Lidocaine on Circulatory Responses During Tracheal Intubation and Postoperative Sore Throat
- ClinicalTrials.gov ID
- NCT01838993
- Acronym / sponsor ID
- CS 2013011
- Conditions
- Sore Throat
- Keywords
- anesthetics,, local,, lidocaine;, nebulizers and vaporizers;, complications,, intubation,, intratracheal.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- New Taipei City HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (estimated)
- First posted
- 24 Apr 2013 (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.
We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction.
Detailed description
Sudden increases in blood pressure and heart rate after tracheal intubation and post-operative sore throat are two common undesirable side effects of general anesthesia and might lead to patients' morbidity or dissatisfaction. We investigated the possibility to attenuate both side effects with one single method, i.e. ultrasound-driven lidocaine inhalation immediately before induction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine inhalationInhalation of lidocaine before intubation |
| Control | Placebo comparator | Drug: PlaceboNormal saline inhalation before intubation |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I or II. Patients scheduled for elective surgery under general anesthesia with orotracheal intubation
Key exclusion criteria (1 listed)
- patient's refusal to join, major surgery or expected operation duration longer than 3 hours, patients with a anticipated difficult airway, requiring a nasogastric tube in peri-operative stage, having recent upper respiratory tract infection (within 1 week) or pre-existing sore throat.
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 inhalationLidocaine inhalation before intubation | Drug | Lidocaine |
| Placebo | Drug | Control |
Primary outcome
Blood pressure
Time frame: 3 min
Non invasive blood pressure every min for 3 min
1 secondary outcome
Post operative sore throat
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
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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.
Chen Yen Po, MD contact
Chen Yen Po, MD principal investigator
New Taipei City 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 inhalation in people with Sore Throat, run by New Taipei City Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 24 Apr 2013. 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 Taiwan. 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 Chen Yen Po, MD (drbrianchan@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 3 min). 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 24 Apr 2013.