A Dose-response Study of Lidocaine and Etomidate

Phase 1

Completed

• Conditions: Etomidate Overdose of Undetermined Intent
• Interventions: Drug: Lidocaine 1mg/kg; Drug: Lidocaine 2mg/kg; Drug: Lidocaine 2.5mg/kg; Drug: Lidocaine 1.5mg/kg

• Registration Number: NCT01916642
• Lead Sponsor: West China Hospital

Brief Summary

IV lidocaine administration can reduce the minimal amount of Etomidate and time for induction of anesthesia.

Detailed Description

The study was carried out in West China Hospital of Sichuan University, Chengdu, China. All the patients were informed in detail about the procedure and the medications they are going to get. Patients are well informed about the beneficial and possible hazards of the medicines and procedure. Patients are also informed that they can withdraw from the study at any time if they find it uncomfortable or harmful for them. Patients' written informed consent was obtained and registered for the permission from the Hospital's Ethics Board.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Study First Submitted: 2013-07-23
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-01
• Last Update Submitted: 2013-08-01
• Study First Posted: 2013-08-05
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients scheduled for Elective Surgery,
2. age limit within 18-70 years,
3. American Society of Anaesthesiologists physical status classification I-II

Exclusion Criteria

1. Adrenal Cortex disorder,
2. Neurologic disease,
3. Psychiatric disorders,
4. Allergic to Local anesthetic drugs,
5. Patients who have received sedatives,analgesics or opioids within the previous 24 hrs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine 1mg/kg	Lidocaine 1mg/kg	Lidocaine 1mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.
Lidocaine 2mg/kg	Lidocaine 2mg/kg	Lidocaine 2mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.
Lidocaine 2.5mg/kg	Lidocaine 2.5mg/kg	Lidocaine 2.5mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.
Lidocaine 1.5mg/kg	Lidocaine 1.5mg/kg	Lidocaine 1.5mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.

Primary Outcome Measures

Name	Time	Method
changes in blood pressure and heart rate.	6 weeks