Back to resultsEffect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia
Primary Purpose
General Anesthesia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lidocaine Hydrochloride Injection
Etomidate Fat Emulsion Injection
normal saline
Midazolam Injection
Fentanyl Citrate Injection
Rocuronium Injection
Sponsored by
About this trial
This is an interventional treatment trial for General Anesthesia
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
Sites / Locations
- TangDu Hospital,FMMURecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Group C
Group L1
Group L2
group L3
Arm 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
severity of myoclonus induced by
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
The intensity of pain was graded using a verbal rating scale. 0-None (negative response to questioning)
Mild pain (pain reported only in response to questioning without any behavioral signs)
Moderate pain (pain reported in response to questioning and accompanied by a behavioral sign or pain reported spontaneously without questioning)
Severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawl or tears)
Secondary Outcome Measures
hemodynamic parameters after injection 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02141737
Brief Title
Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia
Official Title
Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with etomidate during general anesthesia in elderly patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
272 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group C
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Group L1
Arm Type
Experimental
Arm 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.
Arm Title
Group L2
Arm Type
Experimental
Arm 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.
Arm Title
group L3
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride Injection
Intervention 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(s)
Etomidate Fat Emulsion Injection
Other Intervention Name(s)
Fu Er Li
Intervention Description
1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention 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(s)
Midazolam Injection
Other Intervention Name(s)
Li Yue Xi
Intervention Description
0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.
Intervention Type
Drug
Intervention Name(s)
Fentanyl Citrate Injection
Intervention Description
3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam.
Intervention Type
Drug
Intervention Name(s)
Rocuronium Injection
Intervention Description
0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.
Primary Outcome Measure Information:
Title
severity of myoclonus induced by
Description
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)
Time Frame
90 seconds from the beginning of etomidate injection
Title
intensity of injection pain
Description
The intensity of pain was graded using a verbal rating scale. 0-None (negative response to questioning)
Mild pain (pain reported only in response to questioning without any behavioral signs)
Moderate pain (pain reported in response to questioning and accompanied by a behavioral sign or pain reported spontaneously without questioning)
Severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawl or tears)
Time Frame
during the injection of etomidate, expected to be within 1 minutes
Secondary Outcome Measure Information:
Title
hemodynamic parameters after injection of etomidate
Description
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
Time Frame
baseline to 2 minutes after injetion of etomidate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Guo
Phone
+86-18009200936
Email
guoyu986121@163.com
Facility Information:
Facility Name
TangDu Hospital,FMMU
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Guo
Phone
+86-18009200936
Email
guoyu986121@163.com
First Name & Middle Initial & Last Name & Degree
Yu Guo
12. IPD Sharing Statement
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Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia
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