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A Dose-response Study of Lidocaine and Etomidate

S

Sichuan University

Status and phase

Completed
Phase 1

Conditions

Etomidate Overdose of Undetermined Intent

Treatments

Drug: Lidocaine 1.5mg/kg
Drug: Lidocaine 2.5mg/kg
Drug: Lidocaine 1mg/kg
Drug: Lidocaine 2mg/kg

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 5 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
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.
Lidocaine 1mg/kg
Active Comparator group
Description:
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.
Treatment:
Drug: Lidocaine 1mg/kg
Lidocaine 1.5mg/kg
Active Comparator group
Description:
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.
Treatment:
Drug: Lidocaine 1.5mg/kg
Lidocaine 2mg/kg
Active Comparator group
Description:
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.
Treatment:
Drug: Lidocaine 2mg/kg
Lidocaine 2.5mg/kg
Active Comparator group
Description:
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.
Treatment:
Drug: Lidocaine 2.5mg/kg

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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