Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients

NCT ID: NCT03640468

Last Updated: 2018-11-21

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2019-07-01

Brief Summary

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The aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.

Detailed Description

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Most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. Thus, induction of anesthesia in shocked patients might result in deleterious hypotension. Patients with severe sepsis and septic shock frequently need surgical interventions. The best protocol for induction of anesthesia in septic shock patients is lacking.

Ketamine is an agent used for induction of anesthesia with known positive cardiovascular effects. However, these positive effects were reported in individuals with intact sympathetic nervous system. Invitro studies showed that ketamine direct action on the cardiac muscles is negative. Thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present.

Lidocaine is a drug with multiple local and systemic uses. Having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. Lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.

Conditions

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Septic Shock Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketamine group

This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.

Group Type ACTIVE_COMPARATOR

Ketamine full dose

Intervention Type DRUG

This group will receive induction of anesthesia using Ketamine 1 mg/Kg

Midazolam

Intervention Type DRUG

This group will receive midazolam 0.05 mg/Kg

Normal saline

Intervention Type DRUG

This group will receive normal saline 10 mL

Lidocaine-ketamine group

This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.

Group Type EXPERIMENTAL

Ketamine half dose

Intervention Type DRUG

This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg

Lidocaine

Intervention Type DRUG

This group will receive lidocaince 1 mg/Kg

Midazolam

Intervention Type DRUG

This group will receive midazolam 0.05 mg/Kg

Interventions

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Ketamine full dose

This group will receive induction of anesthesia using Ketamine 1 mg/Kg

Intervention Type DRUG

Ketamine half dose

This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg

Intervention Type DRUG

Lidocaine

This group will receive lidocaince 1 mg/Kg

Intervention Type DRUG

Midazolam

This group will receive midazolam 0.05 mg/Kg

Intervention Type DRUG

Normal saline

This group will receive normal saline 10 mL

Intervention Type DRUG

Other Intervention Names

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Ketamine hydrochloride Ketamine Hydrochloride Lidocaine Hydrochloride Dormicum

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged above 18 years
* With septic shock
* Scheduled for general anesthesia

Exclusion Criteria

* Patients under 18 years
* Burn patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Hasanin

Assistant professor of anesthesia and critical care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Hasanin, Professor

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of anesthesia

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Sarah Amin, Lecturer

Role: CONTACT

+201227476617

Other Identifiers

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N-128-2018

Identifier Type: -

Identifier Source: org_study_id

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