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Completed

NCT Number: NCT03844984

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients under 18 years
  • Burn patients

Treatment and study plan

ketamine full dose

Drug

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

Other names: Ketamine hydrochloride

midazolam

Drug

This group will receive midazolam 0.05 mg/Kg

Other names: dormicum

normal saline

Drug

This group will receive normal saline 10 mL

ketamine half dose

Drug

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

Other names: Ketamine hydrochloride

Lidocaine

Drug

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

Other names: Lidocaine hydrochloride

Primary outcomes

  1. Mean arterial blood pressure

    Time frame: 10 minutes after induction of general anesthesia

    Mean arterial blood pressure measured in mmHg

Secondary outcomes

  1. Heart rate

    Time frame: 10 minutes after induction of general anesthesia

    Number of heart beats per minute

  2. The number of patients who suffer from post-induction hypotension.

    Time frame: 5 minutes after induction of general anesthesia

    The 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

  3. Cardiac output

    Time frame: 10 minutes after induction of general anesthesia

    Volume of blood pumped by the heart in one minute measured in liters per minute

  4. Norepinephrine consumption

    Time frame: 10 minutes after induction of general anesthesia

    The total dose of norepinephrine measured in micrograms

  5. Systolic blood pressure

    Time frame: 10 minutes after induction of general anesthesia

    Systolic arterial blood pressure measured in mmHg

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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