Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia

Study Overview
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Brief Summary
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To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with etomidate during general anesthesia in elderly patients

Official Title
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Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia

Conditions
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General Anesthesia

Intervention / Treatment
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* Drug: Lidocaine Hydrochloride Injection
* Drug: Etomidate Fat Emulsion Injection
* Drug: normal saline
* Drug: Midazolam Injection
* Drug: Fentanyl Citrate Injection
* Drug: Rocuronium Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group C<br>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. | Drug: Etomidate Fat Emulsion Injection<br>* 1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.<br>* Other names: Fu Er Li;Drug: normal saline<br>* 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.<br>Drug: Midazolam Injection<br>* 0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.<br>* Other names: Li Yue Xi;Drug: Fentanyl Citrate Injection<br>* 3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam.<br>Drug: Rocuronium Injection<br>* 0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.<br>|
| Experimental: Group L1<br>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. | Drug: Lidocaine Hydrochloride Injection<br>* 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.<br>Drug: Etomidate Fat Emulsion Injection<br>* 1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.<br>* Other names: Fu Er Li;Drug: normal saline<br>* 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.<br>Drug: Midazolam Injection<br>* 0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.<br>* Other names: Li Yue Xi;Drug: Fentanyl Citrate Injection<br>* 3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam.<br>Drug: Rocuronium Injection<br>* 0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.<br>|
| Experimental: Group L2<br>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. | Drug: Lidocaine Hydrochloride Injection<br>* 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.<br>Drug: Etomidate Fat Emulsion Injection<br>* 1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.<br>* Other names: Fu Er Li;Drug: normal saline<br>* 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.<br>Drug: Midazolam Injection<br>* 0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.<br>* Other names: Li Yue Xi;Drug: Fentanyl Citrate Injection<br>* 3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam.<br>Drug: Rocuronium Injection<br>* 0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.<br>|
| Experimental: group L3<br>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. | Drug: Lidocaine Hydrochloride Injection<br>* 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.<br>Drug: Etomidate Fat Emulsion Injection<br>* 1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.<br>* Other names: Fu Er Li;Drug: Midazolam Injection<br>* 0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.<br>* Other names: Li Yue Xi;Drug: Fentanyl Citrate Injection<br>* 3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam.<br>Drug: Rocuronium Injection<br>* 0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | during the injection of etomidate, expected to be within 1 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline to 2 minutes after injetion of etomidate |