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

NCT03640468 — Phase 3, Unknown, 36 participants, Cairo University

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

RegistryNCT03640468
StatusUnknown
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment36 (Estimated)
SponsorCairo University (Other)
ConditionsSeptic Shock, Anesthesia
InterventionsKetamine full dose, Ketamine half dose, Lidocaine, Midazolam, Normal saline (Drug)
Datesstart 2018-12-20 (estimated), primary completion 2019-06-15 (estimated), completion 2019-07-01 (estimated), first posted 2018-08-21, last updated 2018-11-21
Locations1 site in Egypt

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Ketamine groupActive comparatorDrug: Ketamine full dose; Drug: Midazolam; Drug: Normal 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 groupExperimentalDrug: Ketamine half dose; Drug: Lidocaine; Drug: MidazolamThis 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 full dose (Drug), also known as Ketamine hydrochloride: This group will receive induction of anesthesia using Ketamine 1 mg/Kg
  • Ketamine half dose (Drug), also known as Ketamine Hydrochloride: This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg
  • Lidocaine (Drug), also known as Lidocaine Hydrochloride: This group will receive lidocaince 1 mg/Kg
  • Midazolam (Drug), also known as Dormicum: This group will receive midazolam 0.05 mg/Kg
  • Normal saline (Drug): This group will receive normal saline 10 mL

+Outcome measures

Primary outcomes

  • Mean arterial pressure [10 minutes after induction of general anesthesia]: Mean arterial pressure measured in mmHg

Secondary outcomes

  • Heart rate [10 minutes after induction of general anesthesia]: number of heart beats per minutes
  • Cardiac output [10 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 anesthesia [10 minutes after induction of general anesthesia]
  • Norepinephrine consumption [10 minutes after induction of general anesthesia]: The total dose of norepinephrine measured in micrograms

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* Patients under 18 years
* Burn patients

+Locations (1)

FacilityCityCountryStatus
Cairo UniversityCairoEgypt

+Investigators

My Notes