Clinical trial NCT03844984: Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients
Official title: Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Septic Shock
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 43
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 blood pressure
timeFrame: 10 minutes after induction of general anesthesia
Secondary outcomes:
measure: Heart rate
timeFrame: 10 minutes after induction of general anesthesia
measure: The number of patients who suffer from post-induction hypotension.
timeFrame: 5 minutes after induction of general anesthesia
measure: Cardiac output
timeFrame: 10 minutes after induction of general anesthesia
measure: Norepinephrine consumption
timeFrame: 10 minutes after induction of general anesthesia
measure: Systolic blood pressure
timeFrame: 10 minutes after induction of general anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Hasanin
Study officials:
affiliation: Head of department of anesthesia, Cairo University, Egypt
name: Ashraf Rady, Professor
role: STUDY_CHAIR
References:
citation: Fathy S, Hasanin A, Mostafa M, Ramzy E, Sarhan K, Almenesey T, Safina AG, Hosny O, Hamden GA, Gado AA, Mokhtar A. The benefit of adding lidocaine to ketamine during rapid sequence endotracheal intubation in patients with septic shock: A randomised controlled trial. Anaesth Crit Care Pain Med. 2021 Feb;40(1):100731. doi: 10.1016/j.accpm.2020.06.017. Epub 2020 Sep 5.