Etomidate Overdose of Undetermined IntentPhase 1NCT01916642
A Dose-response Study of Lidocaine and Etomidate
A Phase 1 study testing Lidocaine 1mg/kg, Lidocaine 1.5mg/kg and Lidocaine 2mg/kg in people with Etomidate Overdose of Undetermined Intent, run by West China Hospital.
Trial summary
IV lidocaine administration can reduce the minimal amount of Etomidate and time for induction of anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Etomidate Overdose of Undetermined Intent
- What is being tested?
- Lidocaine 1mg/kg, Lidocaine 1.5mg/kg and Lidocaine 2mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Jul 2013
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for Elective Surgery,
- age limit within 18-70 years,
- American Society of Anaesthesiologists physical status classification I-II
Who cannot join
- Adrenal Cortex disorder,
- Neurologic disease,
- Psychiatric disorders,
- Allergic to Local anesthetic drugs,
- Patients who have received sedatives,analgesics or opioids within the previous 24 hrs.
About this study
Official title: Can Intravenous Lidocaine Decrease the Minimal Inducing Dose of Etomidate?: A Randomized Placebo-controlled Dose-response Study.
IV lidocaine administration can reduce the minimal amount of Etomidate and time for induction of anesthesia.
Read the detailed description
The study was carried out in West China Hospital of Sichuan University, Chengdu, China. All the patients were informed in detail about the procedure and the medications they are going to get. Patients are well informed about the beneficial and possible hazards of the medicines and procedure. Patients are also informed that they can withdraw from the study at any time if they find it uncomfortable or harmful for them. Patients' written informed consent was obtained and registered for the permission from the Hospital's Ethics Board.
- Being tested
- Lidocaine 1mg/kg, Lidocaine 1.5mg/kg, Lidocaine 2mg/kg, Lidocaine 2.5mg/kg
- Keywords
- iv lidocaine, inducing dose, etomidate, dose response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1mg/kgDrug
Also called Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033
The total dosage of Etomidate needed for induction of anesthesia is recorded at last.
Lidocaine 1.5mg/kgDrug
Also called Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033
same as other
Lidocaine 2mg/kgDrug
Also called Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033
same as other
Lidocaine 2.5mg/kgDrug
Also called Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033
same as other
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 0.9% Normal Saline is given instead of Lidocaine in the same volume and duration. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex. |
| Lidocaine 1mg/kg | Active comparator | Lidocaine 1mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex. Receives: Drug: Lidocaine 1mg/kg |
| Lidocaine 1.5mg/kg | Active comparator | Lidocaine 1.5mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex. Receives: Drug: Lidocaine 1.5mg/kg |
| Lidocaine 2mg/kg | Active comparator | Lidocaine 2mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex. Receives: Drug: Lidocaine 2mg/kg |
| Lidocaine 2.5mg/kg | Active comparator | Lidocaine 2.5mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex. Receives: Drug: Lidocaine 2.5mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in blood pressure and heart rate.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Etomidate Overdose of Undetermined IntentStudies of the same condition, open and under way.
- More trials run by West China 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niharika Dhakal, West China Hospital
- Investigators
- Liu Jin, MD, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916642
- Sponsor's protocol ID
- 1.1
- Status last verified
- Aug 2013
- First submitted
- 23 Jul 2013
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Intravenous Lidocaine Decrease the Minimal Inducing Dose of Etomidate?: A Randomized Placebo-controlled Dose-response Study.
- ClinicalTrials.gov ID
- NCT01916642
- Acronym / sponsor ID
- 1.1
- Keywords
- iv lidocaine, inducing dose, etomidate, dose response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Aug 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.
IV lidocaine administration can reduce the minimal amount of Etomidate and time for induction of anesthesia.
Detailed description
The study was carried out in West China Hospital of Sichuan University, Chengdu, China. All the patients were informed in detail about the procedure and the medications they are going to get. Patients are well informed about the beneficial and possible hazards of the medicines and procedure. Patients are also informed that they can withdraw from the study at any time if they find it uncomfortable or harmful for them. Patients' written informed consent was obtained and registered for the permission from the Hospital's Ethics Board.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | –0.9% Normal Saline is given instead of Lidocaine in the same volume and duration. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex. |
| Lidocaine 1mg/kg | Active comparator | Drug: Lidocaine 1mg/kgLidocaine 1mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex. |
| Lidocaine 1.5mg/kg | Active comparator | Drug: Lidocaine 1.5mg/kgLidocaine 1.5mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex. |
| Lidocaine 2mg/kg | Active comparator | Drug: Lidocaine 2mg/kgLidocaine 2mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex. |
| Lidocaine 2.5mg/kg | Active comparator | Drug: Lidocaine 2.5mg/kgLidocaine 2.5mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for Elective Surgery,
- age limit within 18-70 years,
- American Society of Anaesthesiologists physical status classification I-II
Key exclusion criteria (5 listed)
- Adrenal Cortex disorder,
- Neurologic disease,
- Psychiatric disorders,
- Allergic to Local anesthetic drugs,
- Patients who have received sedatives,analgesics or opioids within the previous 24 hrs.
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 1mg/kgAlso: Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033The total dosage of Etomidate needed for induction of anesthesia is recorded at last. | Drug | Lidocaine 1mg/kg |
| Lidocaine 1.5mg/kgAlso: Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033same as other | Drug | Lidocaine 1.5mg/kg |
| Lidocaine 2mg/kgAlso: Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033same as other | Drug | Lidocaine 2mg/kg |
| Lidocaine 2.5mg/kgAlso: Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033same as other | Drug | Lidocaine 2.5mg/kg |
Primary outcome
changes in blood pressure and heart rate.
Time frame: 6 weeks
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 5 Aug 2013.
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.
Liu Jin, MD study director
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine 1mg/kg, Lidocaine 1.5mg/kg and Lidocaine 2mg/kg in people with Etomidate Overdose of Undetermined Intent, run by West China Hospital.
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 5 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 5 Aug 2013. 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
changes in blood pressure and heart rate. (time frame: 6 weeks). 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 5 Aug 2013.