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

Phase 3
Conditions
Septic Shock
Anesthesia
Interventions
Registration Number
NCT03640468
Lead Sponsor
Cairo University
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
36
Inclusion Criteria
  • Adult patients aged above 18 years
  • With septic shock
  • Scheduled for general anesthesia
Exclusion Criteria
  • Patients under 18 years
  • Burn patients

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ketamine groupKetamine full doseThis group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
Ketamine groupNormal salineThis group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
Lidocaine-ketamine groupKetamine half doseThis group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.
Lidocaine-ketamine groupMidazolamThis group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.
Ketamine groupMidazolamThis group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
Lidocaine-ketamine groupLidocaineThis group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.
Primary Outcome Measures
NameTimeMethod
Mean arterial pressure10 minutes after induction of general anesthesia

Mean arterial pressure measured in mmHg

Secondary Outcome Measures
NameTimeMethod
Heart rate10 minutes after induction of general anesthesia

number of heart beats per minutes

Cardiac output10 minutes after induction of general anesthesia

volume of blood pumped by the heart in one minute measured in liters per minute

The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia10 minutes after induction of general anesthesia
Norepinephrine consumption10 minutes after induction of general anesthesia

The total dose of norepinephrine measured in micrograms

Trial Locations

Locations (1)

Cairo University

🇪🇬

Cairo, Egypt

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