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

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

Sponsors

Lead Sponsor: Tang-Du Hospital

Source 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

Overall Status Unknown status
Start Date 2014-05-01
Completion Date 2014-10-01
Primary Completion Date 2014-10-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
severity of myoclonus induced by 90 seconds from the beginning of etomidate injection
intensity of injection pain during the injection of etomidate, expected to be within 1 minutes
Secondary Outcome
Measure Time Frame
hemodynamic parameters after injection of etomidate baseline to 2 minutes after injetion of etomidate
Enrollment 272
Condition
Intervention

Intervention Type: Drug

Intervention Name: Lidocaine Hydrochloride Injection

Description: 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.

Intervention Type: Drug

Intervention Name: Etomidate Fat Emulsion Injection

Description: 1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.

Other Name: Fu Er Li

Intervention Type: Drug

Intervention Name: normal saline

Description: 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.

Intervention Type: Drug

Intervention Name: Midazolam Injection

Description: 0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.

Other Name: Li Yue Xi

Intervention Type: Drug

Intervention Name: Fentanyl Citrate Injection

Description: 3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam.

Intervention Type: Drug

Intervention Name: Rocuronium Injection

Description: 0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

60 Years

Maximum Age:

81 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Yu Guo

Phone: +86-18009200936

Email: [email protected]

Location
Facility: Status: Contact: Investigator: TangDu Hospital,FMMU Yu Guo +86-18009200936 [email protected] Yu Guo Principal Investigator
Location Countries

China

Verification Date

2014-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Group C

Type: Placebo Comparator

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.

Label: Group L1

Type: Experimental

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.

Label: Group L2

Type: Experimental

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.

Label: group L3

Type: Experimental

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News