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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03640468
Enrollment
36
Registered
2018-08-21
Start date
2018-12-20
Completion date
2019-07-01
Last updated
2018-11-21

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

Conditions

Anesthesia, 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

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

DRUGLidocaine

This group will receive lidocaince 1 mg/Kg

DRUGMidazolam

This group will receive midazolam 0.05 mg/Kg

DRUGNormal saline

This group will receive normal saline 10 mL

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 pressure10 minutes after induction of general anesthesiaMean arterial pressure measured in mmHg

Secondary

MeasureTime frameDescription
Norepinephrine consumption10 minutes after induction of general anesthesiaThe total dose of norepinephrine measured in micrograms
The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia10 minutes after induction of general anesthesia
Heart rate10 minutes after induction of general anesthesianumber of heart beats per minutes
Cardiac output10 minutes after induction of general anesthesiavolume of blood pumped by the heart in one minute measured in liters per minute

Countries

Egypt

Contacts

Primary ContactSarah Amin, Lecturer
sarahamin_22@hotmail.com+201227476617

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026