Hemodynamic ResponseNCT01238718
Use of Lidocaine in Rapid Sequence Induction
A study testing Lidocaine in people with Hemodynamic Response, run by University of Athens at 1 site in Greece.
Trial summary
Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased in patients that receive rapid sequence induction and intubation, where opioids are spared and intravenous anesthetic agents are not… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hemodynamic Response
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2008to Jul 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- reason for rapid sequence induction (emergency, reflux),
- ASA I-II,
- no antihypertensive drugs,
- no antiarrhythmic drugs
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Lidocaine on Anesthetic Depth During Rapid Sequence Induction
Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased in patients that receive rapid sequence induction and intubation, where opioids are spared and intravenous anesthetic agents are not titrated step by step. Our hypothesis was that lidocaine when administered intravenously in patients who undergo rapid sequence induction may not only blunt the hemodynamic response to intubation, but may also increase the anesthetic depth (as assessed by BIS), thus further reducing the possibility of hypertension, arrhythmias and also awareness.
- Conditions
- Hemodynamic Response
- Being tested
- Lidocaine, Placebo
- Keywords
- lidocaine, anesthetic depth, hemodynamics, rapid sequence induction, BIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
lidocaine 1.5 mg/kg intravenously
PlaceboDrug
normal saline
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Active comparator | Not described Receives: Drug: Lidocaine |
| normal saline | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS changes after lidocaine administration in rapid sequence induction
Measured: change from baseline in BIS values during 10 minutes
Secondary outcomes (2)
change in blood pressure
Measured: change from baseline in blood pressure during 10 minutes
change in Heart rate
Measured: change from baseline in heart rate durng 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startOct 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic ResponseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238718
- Sponsor's protocol ID
- lidocaine3
- Status last verified
- Nov 2010
- First submitted
- 8 Nov 2010
- Last updated
- 24 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lidocaine on Anesthetic Depth During Rapid Sequence Induction
- ClinicalTrials.gov ID
- NCT01238718
- Acronym / sponsor ID
- lidocaine3
- Conditions
- Hemodynamic Response
- Keywords
- lidocaine, anesthetic depth, hemodynamics, rapid sequence induction, BIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Nov 2010 (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.
Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased in patients that receive rapid sequence induction and intubation, where opioids are spared and intravenous anesthetic agents are not titrated step by step. Our hypothesis was that lidocaine when administered intravenously in patients who undergo rapid sequence induction may not only blunt the hemodynamic response to intubation, but may also increase the anesthetic depth (as assessed by BIS), thus further reducing the possibility of hypertension, arrhythmias and also awareness.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Active comparator | Drug: Lidocaine |
| normal saline | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- reason for rapid sequence induction (emergency, reflux),
- ASA I-II,
- no antihypertensive drugs,
- no antiarrhythmic drugs
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lidocainelidocaine 1.5 mg/kg intravenously | Drug | lidocaine |
| Placebonormal saline | Drug | normal saline |
Primary outcome
BIS changes after lidocaine administration in rapid sequence induction
Time frame: change from baseline in BIS values during 10 minutes
2 secondary outcomes
change in blood pressure
Time frame: change from baseline in blood pressure during 10 minutes
change in Heart rate
Time frame: change from baseline in heart rate durng 10 minutes
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 24 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Hemodynamic Response, run by University of Athens at 1 site in Greece.
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 4 inclusion and 0 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 24 Aug 2011. 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 Greece. 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?
BIS changes after lidocaine administration in rapid sequence induction (time frame: change from baseline in BIS values during 10 minutes). 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 Aug 2011.