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

Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03844984
Enrollment
43
Registered
2019-02-19
Start date
2019-02-20
Completion date
2019-09-20
Last updated
2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

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.

Interventions

This group will receive induction of anesthesia using Ketamine 1 mg/Kg.

DRUGMidazolam

This group will receive midazolam 0.05 mg/Kg

DRUGNormal saline

This group will receive normal saline 10 mL

This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg.

DRUGLidocaine

This group will receive lidocaince 1 mg/Kg diluted in 10 mL normal saline.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients under 18 years * Burn patients

Design outcomes

Primary

MeasureTime frameDescription
Mean arterial blood pressure10 minutes after induction of general anesthesiaMean arterial blood pressure measured in mmHg

Secondary

MeasureTime frameDescription
Heart rate10 minutes after induction of general anesthesiaNumber of heart beats per minute
The number of patients who suffer from post-induction hypotension.5 minutes after induction of general anesthesiaThe number of patients who suffer from decreased mean arterial pressure by 10% from the baseline reading during the first 5 minutes after induction of anesthesia
Cardiac output10 minutes after induction of general anesthesiaVolume of blood pumped by the heart in one minute measured in liters per minute
Norepinephrine consumption10 minutes after induction of general anesthesiaThe total dose of norepinephrine measured in micrograms
Systolic blood pressure10 minutes after induction of general anesthesiaSystolic arterial blood pressure measured in mmHg

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026