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A Dose-response Study of Lidocaine and Etomidate

NCT ID: NCT01916642

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Etomidate Overdose of Undetermined Intent

Keywords

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iv lidocaine inducing dose etomidate dose response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Lidocaine 1mg/kg

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Lidocaine 1.5mg/kg

Intervention Type DRUG

same as other

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.

Group Type ACTIVE_COMPARATOR

Lidocaine 2mg/kg

Intervention Type DRUG

same as other

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.

Group Type ACTIVE_COMPARATOR

Lidocaine 2.5mg/kg

Intervention Type DRUG

same as other

Interventions

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Lidocaine 1mg/kg

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

Intervention Type DRUG

Lidocaine 1.5mg/kg

same as other

Intervention Type DRUG

Lidocaine 2mg/kg

same as other

Intervention Type DRUG

Lidocaine 2.5mg/kg

same as other

Intervention Type DRUG

Other Intervention Names

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Lidocaine serial number:1303E11 Etomidate-Lipuro serial number:11215033 Lidocaine serial number:1303E11 Etomidate-Lipuro serial number:11215033 Lidocaine serial number:1303E11 Etomidate-Lipuro serial number:11215033 Lidocaine serial number:1303E11 Etomidate-Lipuro serial number:11215033

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Niharika Dhakal

Resident,Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liu Jin, MD

Role: STUDY_DIRECTOR

West China Hospital

Other Identifiers

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1.1

Identifier Type: -

Identifier Source: org_study_id