Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Septic Shock

Treatments: Drug: ketamine full dose; Drug: Lidocaine; Drug: Normal saline; Drug: ketamine half dose; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT03844984

N128-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients under 18 years
• Burn patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups

Ketamine group

Active Comparator group

Description:

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

Treatment:

Drug: Normal saline

Drug: Midazolam

Drug: ketamine full dose

Lidocaine-ketamine group

Experimental group

Description:

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.

Treatment:

Drug: Midazolam

Drug: ketamine half dose

Drug: Lidocaine