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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02141737
• Other study ID #: 20140514
• Status: Recruiting
• Phase: Phase 4
• First received: May 15, 2014
• Last updated: May 16, 2014
• Start date: May 2014
• Est. completion date: October 2014

Study information

• Verified date: May 2014
• Source: Tang-Du Hospital
• Contact: Yu Guo
• Phone: +86-18009200936
• Email: guoyu986121[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 81 Years

Eligibility

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: ? or ? 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anesthesia

Intervention

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.
• Etomidate Fat Emulsion Injection
1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.
• 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.
• Midazolam Injection
0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.
• Fentanyl Citrate Injection
3 µg/kg fentanyl will be given to patients in all groups after the injection of midazolam.
• Rocuronium Injection
0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.

Locations

Country	Name	City	State
China	TangDu Hospital,FMMU	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	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	Yes