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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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ClinicalTrials.gov Identifier: NCT02141737
Recruitment Status : Unknown
Verified May 2014 by Tang-Du Hospital.
Recruitment status was:  Recruiting
First Posted : May 19, 2014
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
General Anesthesia Drug: Lidocaine Hydrochloride Injection Drug: Etomidate Fat Emulsion Injection Drug: normal saline Drug: Midazolam Injection Drug: Fentanyl Citrate Injection Drug: Rocuronium Injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia
Study Start Date : May 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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.
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.
Other Name: Fu Er Li

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.

Drug: Midazolam Injection
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

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

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

Experimental: 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.
Drug: 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.

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.
Other Name: Fu Er Li

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.

Drug: Midazolam Injection
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

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

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

Experimental: 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.
Drug: 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.

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.
Other Name: Fu Er Li

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.

Drug: Midazolam Injection
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

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

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

Experimental: 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.
Drug: 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.

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.
Other Name: Fu Er Li

Drug: Midazolam Injection
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

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

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




Primary Outcome Measures :
  1. severity of myoclonus induced by [ Time Frame: 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)

  2. intensity of injection pain [ Time Frame: 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 Outcome Measures :
  1. hemodynamic parameters after injection of etomidate [ Time Frame: 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



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Ages Eligible for Study:   60 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141737


Contacts
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Contact: Yu Guo +86-18009200936 guoyu986121@163.com

Locations
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China, Shanxi
TangDu Hospital,FMMU Recruiting
Xi'an, Shanxi, China
Contact: Yu Guo    +86-18009200936    guoyu986121@163.com   
Principal Investigator: Yu Guo         
Sponsors and Collaborators
Tang-Du Hospital
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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02141737    
Other Study ID Numbers: 20140514
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Myoclonus
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Lidocaine
Fentanyl
Midazolam
Etomidate
Rocuronium
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs