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

Study Overview
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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.

Official Title
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Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial

Conditions
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Septic Shock, Anesthesia

Intervention / Treatment
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* Drug: Ketamine full dose
* Drug: Ketamine half dose
* Drug: Lidocaine
* Drug: Midazolam
* Drug: Normal saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine group<br>This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL. | Drug: Ketamine full dose<br>* This group will receive induction of anesthesia using Ketamine 1 mg/Kg<br>* Other names: Ketamine hydrochloride;Drug: Midazolam<br>* This group will receive midazolam 0.05 mg/Kg<br>* Other names: Dormicum;Drug: Normal saline<br>* This group will receive normal saline 10 mL<br>|
| Experimental: Lidocaine-ketamine group<br>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. | Drug: Ketamine half dose<br>* This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg<br>* Other names: Ketamine Hydrochloride;Drug: Lidocaine<br>* This group will receive lidocaince 1 mg/Kg<br>* Other names: Lidocaine Hydrochloride;Drug: Midazolam<br>* This group will receive midazolam 0.05 mg/Kg<br>* Other names: Dormicum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure | Mean arterial pressure measured in mmHg | 10 minutes after induction of general anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | number of heart beats per minutes | 10 minutes after induction of general anesthesia | 
| Cardiac output | volume of blood pumped by the heart in one minute measured in liters per minute | 10 minutes after induction of general anesthesia | 
| The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia |  | 10 minutes after induction of general anesthesia | 
| Norepinephrine consumption | The total dose of norepinephrine measured in micrograms | 10 minutes after induction of general anesthesia |