Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia
Phase 4
- Conditions
- General Anesthesia
- Interventions
- Registration Number
- NCT02141737
- Lead Sponsor
- Tang-Du Hospital
- Brief Summary
To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with etomidate during general anesthesia in elderly patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 272
Inclusion Criteria
-
- 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
-
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C normal saline 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. Group C Fentanyl Citrate Injection 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. Group L1 Etomidate Fat Emulsion Injection 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. Group L1 normal saline 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. Group L2 Etomidate Fat Emulsion Injection 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. Group L2 normal saline 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. group L3 Etomidate Fat Emulsion Injection 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. group L3 Midazolam Injection 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. Group C Midazolam Injection 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. Group L1 Midazolam Injection 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. Group L2 Midazolam Injection 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. Group C Rocuronium Injection 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. Group L1 Fentanyl Citrate Injection 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. Group L1 Rocuronium Injection 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. Group L2 Fentanyl Citrate Injection 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. Group L2 Rocuronium Injection 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. group L3 Rocuronium Injection 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. Group L1 Lidocaine Hydrochloride Injection 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. Group L2 Lidocaine Hydrochloride Injection 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. group L3 Lidocaine Hydrochloride Injection 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. Group C Etomidate Fat Emulsion Injection 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. group L3 Fentanyl Citrate Injection 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.
- Primary Outcome Measures
Name Time Method severity of myoclonus induced by 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 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)
- Secondary Outcome Measures
Name Time Method hemodynamic parameters after injection of etomidate baseline to 2 minutes after injetion 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
Trial Locations
- Locations (1)
TangDu Hospital,FMMU
🇨🇳Xi'an, Shanxi, China