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

Tang-Du Hospital

Status and phase: Unknown; Phase 4

Conditions: General Anesthesia

Treatments: Drug: Lidocaine Hydrochloride Injection; Drug: Midazolam Injection; Drug: Etomidate Fat Emulsion Injection; Drug: Fentanyl Citrate Injection; Drug: Rocuronium Injection; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02141737

20140514

Details and patient eligibility

About

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

Enrollment: 272 estimated patients

Sex: All

Ages: 60 to 81 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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272 participants in 4 patient groups, including a placebo group

Group C

Placebo Comparator group

Description:

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.

Treatment:

Drug: Fentanyl Citrate Injection

Drug: normal saline

Drug: Etomidate Fat Emulsion Injection

Drug: Rocuronium Injection

Drug: Midazolam Injection

Group L1

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Citrate Injection

Drug: normal saline

Drug: Etomidate Fat Emulsion Injection

Drug: Rocuronium Injection

Drug: Lidocaine Hydrochloride Injection

Drug: Midazolam Injection

Group L2

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Citrate Injection

Drug: normal saline

Drug: Etomidate Fat Emulsion Injection

Drug: Rocuronium Injection

Drug: Lidocaine Hydrochloride Injection

Drug: Midazolam Injection

group L3

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Citrate Injection

Drug: Etomidate Fat Emulsion Injection

Drug: Rocuronium Injection

Drug: Lidocaine Hydrochloride Injection

Drug: Midazolam Injection