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

NCT ID: NCT02141737

Last Updated: 2014-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

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

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group C

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 Type PLACEBO_COMPARATOR

Etomidate Fat Emulsion Injection

Intervention Type DRUG

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

normal saline

Intervention Type DRUG

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.

Midazolam Injection

Intervention Type DRUG

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

Fentanyl Citrate Injection

Intervention Type DRUG

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

Rocuronium Injection

Intervention Type DRUG

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

Group L1

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 Type EXPERIMENTAL

Lidocaine Hydrochloride Injection

Intervention Type DRUG

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.

Etomidate Fat Emulsion Injection

Intervention Type DRUG

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

normal saline

Intervention Type DRUG

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.

Midazolam Injection

Intervention Type DRUG

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

Fentanyl Citrate Injection

Intervention Type DRUG

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

Rocuronium Injection

Intervention Type DRUG

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

Group L2

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 Type EXPERIMENTAL

Lidocaine Hydrochloride Injection

Intervention Type DRUG

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.

Etomidate Fat Emulsion Injection

Intervention Type DRUG

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

normal saline

Intervention Type DRUG

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.

Midazolam Injection

Intervention Type DRUG

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

Fentanyl Citrate Injection

Intervention Type DRUG

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

Rocuronium Injection

Intervention Type DRUG

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

group L3

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 Type EXPERIMENTAL

Lidocaine Hydrochloride Injection

Intervention Type DRUG

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.

Etomidate Fat Emulsion Injection

Intervention Type DRUG

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

Midazolam Injection

Intervention Type DRUG

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

Fentanyl Citrate Injection

Intervention Type DRUG

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

Rocuronium Injection

Intervention Type DRUG

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

Interventions

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Lidocaine Hydrochloride Injection

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

Etomidate Fat Emulsion Injection

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

Intervention Type DRUG

normal 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.

Intervention Type DRUG

Midazolam Injection

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

Intervention Type DRUG

Fentanyl Citrate Injection

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

Intervention Type DRUG

Rocuronium Injection

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

Intervention Type DRUG

Other Intervention Names

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Fu Er Li Li Yue Xi

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TangDu Hospital,FMMU

Xi’an, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu Guo

Role: CONTACT

+86-18009200936

Facility Contacts

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Yu Guo

Role: primary

+86-18009200936

Other Identifiers

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20140514

Identifier Type: -

Identifier Source: org_study_id

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