A Dose-response Study of Lidocaine and Etomidate

August 1, 2013 updated by: Niharika Dhakal, West China Hospital

Can Intravenous Lidocaine Decrease the Minimal Inducing Dose of Etomidate?: A Randomized Placebo-controlled Dose-response Study.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
The total dosage of Etomidate needed for induction of anesthesia is recorded at last.
Other Names:
  • Lidocaine
  • serial number:1303E11
  • Etomidate-Lipuro
  • serial number:11215033
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
same as other
Other Names:
  • Lidocaine
  • serial number:1303E11
  • Etomidate-Lipuro
  • serial number:11215033
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
same as other
Other Names:
  • Lidocaine
  • serial number:1303E11
  • Etomidate-Lipuro
  • serial number:11215033
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
same as other
Other Names:
  • Lidocaine
  • serial number:1303E11
  • Etomidate-Lipuro
  • serial number:11215033

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in blood pressure and heart rate.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Study Director: Liu Jin, MD, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Estimate)

August 5, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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