A Phase 4 interventional study of Lidocaine Hydrochloride Injection and Etomidate Fat Emulsion Injection in General Anesthesia, sponsored by Tang-Du Hospital. Status unknown at 1 site in China. Open to participants aged 60 Years to 81 Years. Per ClinicalTrials.gov, last updated 2014-05-19.
Sponsored by Tang-Du Hospital · Phase 4, Interventional, and Treatment
To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with etomidate during general anesthesia in elderly patients
Tang-Du Hospital is the lead sponsor of 167 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: normal saline · Drug: Midazolam Injection · Drug: Fentanyl Citrate Injection · Drug: Rocuronium Injection
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 · Drug: Etomidate Fat Emulsion Injection · Drug: normal saline · Drug: Midazolam Injection · Drug: Fentanyl Citrate Injection · Drug: Rocuronium Injection
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 · Drug: Etomidate Fat Emulsion Injection · Drug: normal saline · Drug: Midazolam Injection · Drug: Fentanyl Citrate Injection · Drug: Rocuronium Injection
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 · Drug: Etomidate Fat Emulsion Injection · Drug: Midazolam Injection · Drug: Fentanyl Citrate Injection · Drug: Rocuronium 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.
1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.
Also known as: Fu Er Li
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.
0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.
Also known as: Li Yue Xi
3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam.
0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.
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)
Time frame: 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) 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)
Time frame: during the injection of etomidate, expected to be within 1 minutes
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
Time frame: baseline to 2 minutes after injetion of etomidate
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine