Neurosurgical PatientsNCT01737437
Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation
A study testing group C, group L and group V in people with Neurosurgical Patients, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
A previous study demonstrated topical lidocaine spray on the larynx and the trachea is effective in reducing hemodynamic response to laryngoscopy and endotracheal intubation. In clinical practice, blind oropharyngeal application of lidocaine without aiding direct laryngoscopy can not assured that sprayed lidocaine… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurosurgical Patients
- What is being tested?
- group C, group L and group V
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Jan 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 20-60 years,
- ASA groups I or II
Who cannot join
- ASA III or IV,
- hypertension,
- anticipated difficult airway, and
- severe coronary and cerebrovascular diseases
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 110-744
Hee-Pyoung PARK, MD PhD, 82-2-2072-2466, hppark@snu.ac.kr
Hee-Pyung Park, MD PhD
About this study
Official title: Effect of Lidocaine Sprayed on Direct Laryngoscopy and Trachea on Hemodynamics During Endotracheal Intubation
A previous study demonstrated topical lidocaine spray on the larynx and the trachea is effective in reducing hemodynamic response to laryngoscopy and endotracheal intubation. In clinical practice, blind oropharyngeal application of lidocaine without aiding direct laryngoscopy can not assured that sprayed lidocaine effectively reaches the larynx and trachea. Therefore, direct laryngoscopy should be necessary to reach topical lidocaine to correct sites. Unfortunately, direct laryngoscopy itself can affect hemodynamics during spraying lidocaine. In this study, we will investigate an effect of lidocaine sprayed on direct laryngoscopy and the tracheal mucosa on hemodynamic change throughout intubation.
- Conditions
- Neurosurgical Patients
- Being tested
- group C, group L, group V, group LV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group CDrug
0.9% normal saline was applied to trachea and laryngoscope blade
group LDrug
10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.
group VDrug
0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.
group LVDrug
10% Lidocaine was applied on laryngoscope blade and trachea.
| Study group | Role | What they receive |
|---|---|---|
| group L | Experimental | 10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea. Receives: Drug: group L |
| group C | Placebo comparator | 0.9% normal saline was applied to trachea and laryngoscope blade in Group C. Receives: Drug: group C |
| group V | Experimental | 0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea. Receives: Drug: group V |
| group LV | Experimental | 10% Lidocaine was applied on laryngoscope blade and trachea. Receives: Drug: group LV |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean blood pressure, heart rate
Measured: baseline, at laryngoscope insertion, 60s after laryngoscope insertion, during intubation, one, two, three min after endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurosurgical PatientsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737437
- Sponsor's protocol ID
- php1
- Status last verified
- Nov 2012
- First submitted
- 20 Nov 2012
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine Sprayed on Direct Laryngoscopy and Trachea on Hemodynamics During Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT01737437
- Acronym / sponsor ID
- php1
- Conditions
- Neurosurgical Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 29 Nov 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.
A previous study demonstrated topical lidocaine spray on the larynx and the trachea is effective in reducing hemodynamic response to laryngoscopy and endotracheal intubation. In clinical practice, blind oropharyngeal application of lidocaine without aiding direct laryngoscopy can not assured that sprayed lidocaine effectively reaches the larynx and trachea. Therefore, direct laryngoscopy should be necessary to reach topical lidocaine to correct sites. Unfortunately, direct laryngoscopy itself can affect hemodynamics during spraying lidocaine. In this study, we will investigate an effect of lidocaine sprayed on direct laryngoscopy and the tracheal mucosa on hemodynamic change throughout intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group L | Experimental | Drug: group L10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea. |
| group C | Placebo comparator | Drug: group C0.9% normal saline was applied to trachea and laryngoscope blade in Group C. |
| group V | Experimental | Drug: group V0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea. |
| group LV | Experimental | Drug: group LV10% Lidocaine was applied on laryngoscope blade and trachea. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged 20-60 years,
- ASA groups I or II
Key exclusion criteria (4 listed)
- ASA III or IV,
- hypertension,
- anticipated difficult airway, and
- severe coronary and cerebrovascular diseases
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 |
|---|---|---|
| group C0.9% normal saline was applied to trachea and laryngoscope blade | Drug | group C |
| group L10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea. | Drug | group L |
| group V0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea. | Drug | group V |
| group LV10% Lidocaine was applied on laryngoscope blade and trachea. | Drug | group LV |
Primary outcome
mean blood pressure, heart rate
Time frame: baseline, at laryngoscope insertion, 60s after laryngoscope insertion, during intubation, one, two, three min after endotracheal intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group C, group L and group V in people with Neurosurgical Patients, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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 29 Nov 2012. 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 South Korea. 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 SUE YOUNG LEE, MD (82-10-9700-6509, tndude49@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean blood pressure, heart rate (time frame: baseline, at laryngoscope insertion, 60s after laryngoscope insertion, during intubation, one, two, three min after endotracheal intubation). 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 29 Nov 2012.