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CompletedNCT01916642Updated Aug 5, 2013

A Dose-response Study of Lidocaine and Etomidate

A Phase 1 interventional study of Lidocaine 1mg/kg and Lidocaine 1.5mg/kg in Etomidate Overdose of Undetermined Intent, sponsored by West China Hospital. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-05.

Sponsored by West China Hospital · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Etomidate Overdose of Undetermined Intent

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Keywords

  • iv lidocaine
  • inducing dose
  • etomidate
  • dose response
03

In context

Drug Overdose

139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 98 interventional studies indexed under Drug Overdose.

Browse Drug Overdose studies →

Lead sponsor

West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (actual)

Study arms

  • Placebo comparator
    Control

    0.9% Normal Saline is given instead of Lidocaine in the same volume and duration. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.

  • Active comparator
    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.

    Drug: Lidocaine 1mg/kg

  • Active comparator
    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.

    Drug: Lidocaine 1.5mg/kg

  • Active comparator
    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.

    Drug: Lidocaine 2mg/kg

  • Active comparator
    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.

    Drug: Lidocaine 2.5mg/kg

Interventions

  • DrugLidocaine 1mg/kg

    The total dosage of Etomidate needed for induction of anesthesia is recorded at last.

    Also known as: Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033

  • DrugLidocaine 1.5mg/kg

    same as other

    Also known as: Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033

  • DrugLidocaine 2mg/kg

    same as other

    Also known as: Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033

  • DrugLidocaine 2.5mg/kg

    same as other

    Also known as: Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033

06

What researchers measure

Primary outcomes

  1. changes in blood pressure and heart rate.

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01916642
Lead sponsor
West China Hospital
Responsible party
Niharika Dhakal (Resident,Department of Anesthesiology, West China Hospital) — Principal investigator
First posted
Aug 5, 2013
Start date
Apr 2013
Primary completion
Jun 2013
Completion
Jul 2013
Last update
Aug 5, 2013

Study contacts

Liu Jin, MD
study director · West China Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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