General AnesthesiaPhase 4NCT02141737
Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia
A Phase 4 study testing Lidocaine Hydrochloride Injection, Etomidate Fat Emulsion Injection and normal saline in people with General Anesthesia, run by Tang-Du Hospital at 1 site in China.
Trial summary
To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with etomidate during general anesthesia in elderly patients Read more about this study
- Who is it for?
- Ages 60 to 81 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Lidocaine Hydrochloride Injection, Etomidate Fat Emulsion Injection and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Oct 2014
- Phase
- Phase 4
- 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 60 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged between 60 and 81 years 2. Body mass index: 20 to 30 kg/m2 3. American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ 4. Signed informed consent form
Who cannot join
- 1. Use of sedatives or opioids 2. History of central nervous system diseases, like epilepsy, shaking palsy, or chorea, etc 3. Hyperthyroidism 4. Serious diabetes 5. Hyperkalemia 6. Cardiac surgery 7. Serious ventricular disease or atrioventricular block 8. Liver or renal dysfunction 9. Allergies to amide local anesthetics or fat emulsion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TangDu Hospital,FMMU
Xi’an, Shanxi
Yu Guo, +86-18009200936, guoyu986121@163.com
Yu Guo
About this study
To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with etomidate during general anesthesia in elderly patients
- Conditions
- General Anesthesia
- Being tested
- Lidocaine Hydrochloride Injection, Etomidate Fat Emulsion Injection, normal saline, Midazolam Injection, Fentanyl Citrate Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Hydrochloride InjectionDrug
Lidocaine injection should be give before the injection of etomidate. In groups L1 and L2, 20 mg and 30 mg lidocaine injection will be diluted to 2ml separately.
Etomidate Fat Emulsion InjectionDrug
Also called Fu Er Li
1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.
normal salineDrug
2 ml normal saline will be given 1 minute before the injection of etomidate in patients in group C, and in group L1 and L2, normal saline is used to dilute lidocaine injection to 2 ml.
Midazolam InjectionDrug
Also called Li Yue Xi
0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.
Fentanyl Citrate InjectionDrug
3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam.
Rocuronium InjectionDrug
0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | Induction protocol: patients will be given 2 ml normal saline solution, 1 minutes later, 0.3 mg/kg etomidate is injected within 30 to 60 s, and 90 s after the injection of etomidate, 0.2 mg/kg midazolam, 3 μg/kg fentanyl, 0.6 mg/kg rocuronium are given sequently. Receives: Drug: Etomidate Fat Emulsion Injection; Drug: normal saline; Drug: Midazolam Injection; Drug: Fentanyl Citrate Injection; Drug: Rocuronium Injection |
| Group L1 | Experimental | Induction protocol: patients will be given 2 ml diluted lidocaine injection in which 20 mg lidocaine is contained, 1 minutes later, 0.3 mg/kg etomidate is injected within 30 to 60 s, and 90 s after the injection of etomidate, 0.2 mg/kg midazolam, 3 μg/kg fentanyl, 0.6 mg/kg rocuronium are given sequently. Receives: Drug: Lidocaine Hydrochloride Injection; Drug: Etomidate Fat Emulsion Injection; Drug: normal saline; Drug: Midazolam Injection; Drug: Fentanyl Citrate Injection; Drug: Rocuronium Injection |
| Group L2 | Experimental | Induction protocol: patients will be given 2 ml diluted lidocaine injection in which 30 mg lidocaine is contained, 1 minutes later, 0.3 mg/kg etomidate is injected within 30 to 60 s, and 90 s after the injection of etomidate, 0.2 mg/kg midazolam, 3 μg/kg fentanyl, 0.6 mg/kg rocuronium are given sequently. Receives: Drug: Lidocaine Hydrochloride Injection; Drug: Etomidate Fat Emulsion Injection; Drug: normal saline; Drug: Midazolam Injection; Drug: Fentanyl Citrate Injection; Drug: Rocuronium Injection |
| group L3 | Experimental | Induction protocol: patients will be given 2 ml lidocaine injection in which 40 mg lidocaine is contained, 1 minutes later, 0.3 mg/kg etomidate is injected within 30 to 60 s, and 90 s after the injection of etomidate, 0.2 mg/kg midazolam, 3 μg/kg fentanyl, 0.6 mg/kg rocuronium are given sequently. Receives: Drug: Lidocaine Hydrochloride Injection; Drug: Etomidate Fat Emulsion Injection; Drug: Midazolam Injection; Drug: Fentanyl Citrate Injection; Drug: Rocuronium Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of myoclonus induced by
myoclonic movements are graded as 0=no myoclonus, 1=mild myoclonus (short movement of a body segment e.g., a finger or a wrist), 2=moderate myoclonus (mild movement of two different muscle groups e.g., face and arm), or 3=severe myoclonus (intense myoclonic movement in two or more muscle groups, fast adduction of a limb)
Measured: 90 seconds from the beginning of etomidate injection
intensity of injection pain
The intensity of pain was graded using a verbal rating scale. 0-None (negative response to questioning)
- Mild pain (pain reported only in response to questioning without any behavioral signs)
- Moderate pain (pain reported in response to questioning and accompanied by a behavioral sign or pain reported spontaneously without questioning)
- Severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawl or tears)
Measured: during the injection of etomidate, expected to be within 1 minutes
Secondary outcomes (1)
hemodynamic parameters after injection of etomidate
Heart rate and mean arterial pressure will be recorded before induction, before the injection of etomidate, 1 minute and 2 minutes after injection of etomidate
Measured: baseline to 2 minutes after injetion of etomidate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tang-Du 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141737
- Sponsor's protocol ID
- 20140514
- Status last verified
- May 2014
- First submitted
- 15 May 2014
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia
- ClinicalTrials.gov ID
- NCT02141737
- Acronym / sponsor ID
- 20140514
- Conditions
- General Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 19 May 2014 (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.
To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with etomidate during general anesthesia in elderly patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Drug: Etomidate Fat Emulsion Injection, Drug: normal saline, Drug: Midazolam Injection, Drug: Fentanyl Citrate Injection, Drug: Rocuronium InjectionInduction protocol: patients will be given 2 ml normal saline solution, 1 minutes later, 0.3 mg/kg etomidate is injected within 30 to 60 s, and 90 s after the injection of etomidate, 0.2 mg/kg midazolam, 3 μg/kg fentanyl, 0.6 mg/kg rocuronium are given sequently. |
| Group L1 | Experimental | Drug: Lidocaine Hydrochloride Injection, Drug: Etomidate Fat Emulsion Injection, Drug: normal saline, Drug: Midazolam Injection, Drug: Fentanyl Citrate Injection, Drug: Rocuronium InjectionInduction protocol: patients will be given 2 ml diluted lidocaine injection in which 20 mg lidocaine is contained, 1 minutes later, 0.3 mg/kg etomidate is injected within 30 to 60 s, and 90 s after the injection of etomidate, 0.2 mg/kg midazolam, 3 μg/kg fentanyl, 0.6 mg/kg rocuronium are given sequently. |
| Group L2 | Experimental | Drug: Lidocaine Hydrochloride Injection, Drug: Etomidate Fat Emulsion Injection, Drug: normal saline, Drug: Midazolam Injection, Drug: Fentanyl Citrate Injection, Drug: Rocuronium InjectionInduction protocol: patients will be given 2 ml diluted lidocaine injection in which 30 mg lidocaine is contained, 1 minutes later, 0.3 mg/kg etomidate is injected within 30 to 60 s, and 90 s after the injection of etomidate, 0.2 mg/kg midazolam, 3 μg/kg fentanyl, 0.6 mg/kg rocuronium are given sequently. |
| group L3 | Experimental | Drug: Lidocaine Hydrochloride Injection, Drug: Etomidate Fat Emulsion Injection, Drug: Midazolam Injection, Drug: Fentanyl Citrate Injection, Drug: Rocuronium InjectionInduction protocol: patients will be given 2 ml lidocaine injection in which 40 mg lidocaine is contained, 1 minutes later, 0.3 mg/kg etomidate is injected within 30 to 60 s, and 90 s after the injection of etomidate, 0.2 mg/kg midazolam, 3 μg/kg fentanyl, 0.6 mg/kg rocuronium are given sequently. |
Who may qualify
- Ages
- 60 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Aged between 60 and 81 years 2. Body mass index: 20 to 30 kg/m2 3. American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ 4. Signed informed consent form
Key exclusion criteria (1 listed)
- 1. Use of sedatives or opioids 2. History of central nervous system diseases, like epilepsy, shaking palsy, or chorea, etc 3. Hyperthyroidism 4. Serious diabetes 5. Hyperkalemia 6. Cardiac surgery 7. Serious ventricular disease or atrioventricular block 8. Liver or renal dysfunction 9. Allergies to amide local anesthetics or fat emulsion
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 Hydrochloride InjectionLidocaine injection should be give before the injection of etomidate. In groups L1 and L2, 20 mg and 30 mg lidocaine injection will be diluted to 2ml separately. | Drug | Group L1, Group L2, group L3 |
| Etomidate Fat Emulsion InjectionAlso: Fu Er Li1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s. | Drug | Group C, Group L1, Group L2, group L3 |
| normal saline2 ml normal saline will be given 1 minute before the injection of etomidate in patients in group C, and in group L1 and L2, normal saline is used to dilute lidocaine injection to 2 ml. | Drug | Group C, Group L1, Group L2 |
| Midazolam InjectionAlso: Li Yue Xi0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate. | Drug | Group C, Group L1, Group L2, group L3 |
| Fentanyl Citrate Injection3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam. | Drug | Group C, Group L1, Group L2, group L3 |
| Rocuronium Injection0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl. | Drug | Group C, Group L1, Group L2, group L3 |
Primary outcome
severity of myoclonus induced by
Time frame: 90 seconds from the beginning of etomidate injection
myoclonic movements are graded as 0=no myoclonus, 1=mild myoclonus (short movement of a body segment e.g., a finger or a wrist), 2=moderate myoclonus (mild movement of two different muscle groups e.g., face and arm), or 3=severe myoclonus (intense myoclonic movement in two or more muscle groups, fast adduction of a limb)
intensity of injection pain
Time frame: during the injection of etomidate, expected to be within 1 minutes
The intensity of pain was graded using a verbal rating scale. 0-None (negative response to questioning) 1. Mild pain (pain reported only in response to questioning without any behavioral signs) 2. Moderate pain (pain reported in response to questioning and accompanied by a behavioral sign or pain reported spontaneously without questioning) 3. Severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawl or tears)
1 secondary outcome
hemodynamic parameters after injection of etomidate
Time frame: baseline to 2 minutes after injetion of etomidate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
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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 Phase 4 study testing Lidocaine Hydrochloride Injection, Etomidate Fat Emulsion Injection and normal saline in people with General Anesthesia, run by Tang-Du Hospital at 1 site in China.
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 19 May 2014. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yu Guo (+86-18009200936, guoyu986121@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of myoclonus induced by (time frame: 90 seconds from the beginning of etomidate injection). The study lists 2 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 19 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.