Clinical trial NCT03640468: Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients
Official title: Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Septic Shock
Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients under 18 years
* Burn patients

Primary outcomes:
measure: Mean arterial pressure
timeFrame: 10 minutes after induction of general anesthesia
Secondary outcomes:
measure: Heart rate
timeFrame: 10 minutes after induction of general anesthesia
measure: Cardiac output
timeFrame: 10 minutes after induction of general anesthesia
measure: The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia
timeFrame: 10 minutes after induction of general anesthesia
measure: Norepinephrine consumption
timeFrame: 10 minutes after induction of general anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Assistant professor of anesthesia
name: Ahmed Hasanin, Professor
role: PRINCIPAL_INVESTIGATOR
References: