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

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

Study Overview

• Status: Unknown
• Conditions: General Anesthesia
• Intervention / Treatment: Drug: Etomidate Fat Emulsion Injection; Drug: normal saline; Drug: Midazolam Injection; Drug: Fentanyl Citrate Injection; Drug: Rocuronium Injection; Drug: Lidocaine Hydrochloride Injection

• Study Type: Interventional
• Enrollment (Anticipated): 272
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China
      • Recruiting
      • TangDu Hospital,FMMU
      • Contact: Yu Guo; Phone Number: +86-18009200936; Email: guoyu986121@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 81 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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: 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 Names: 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 Names: 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.; 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.
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: 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 Names: 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 Names: 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.; 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.
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: 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 Names: 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 Names: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	90 seconds from the beginning of etomidate injection
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)	during the injection of etomidate, expected to be within 1 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline to 2 minutes after injetion of etomidate

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ANTICIPATED): October 1, 2014
• Study Completion (ANTICIPATED): October 1, 2014

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: May 16, 2014
• First Posted (ESTIMATE): May 19, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 19, 2014
• Last Update Submitted That Met QC Criteria: May 16, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Myoclonus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Fentanyl; Midazolam; Lidocaine; Rocuronium; Etomidate
• Other Study ID Numbers: 20140514