General Anesthesia
Conditions
Brief summary
To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with etomidate during general anesthesia in elderly patients
Interventions
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.
1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.
DRUGnormal saline
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.
DRUGMidazolam Injection
0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.
3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam.
0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 81 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYu Guo
Outcome results
None listed