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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03640468
• Other study ID #: N-128-2018
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 20, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: November 2018
• Source: Cairo University
• Contact: Sarah Amin, Lecturer
• Phone: +201227476617
• Email: sarahamin_22[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: July 1, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients aged above 18 years

• With septic shock

• Scheduled for general anesthesia

Exclusion Criteria:

• Patients under 18 years

• Burn patients

Related Conditions & MeSH terms

• Anesthesia
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Ketamine full dose
This group will receive induction of anesthesia using Ketamine 1 mg/Kg
• Ketamine half dose
This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg
• Lidocaine
This group will receive lidocaince 1 mg/Kg
• Midazolam
This group will receive midazolam 0.05 mg/Kg
• Normal saline
This group will receive normal saline 10 mL

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure	Mean arterial pressure measured in mmHg	10 minutes after induction of general anesthesia
Secondary	Heart rate	number of heart beats per minutes	10 minutes after induction of general anesthesia
Secondary	Cardiac output	volume of blood pumped by the heart in one minute measured in liters per minute	10 minutes after induction of general anesthesia
Secondary	The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia		10 minutes after induction of general anesthesia
Secondary	Norepinephrine consumption	The total dose of norepinephrine measured in micrograms	10 minutes after induction of general anesthesia