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

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
ketamine full dose
Midazolam
Normal saline
ketamine half dose
Lidocaine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients under 18 years
  • Burn patients

Sites / Locations

  • Ahmed Mohamed Hasanin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ketamine group

Lidocaine-ketamine group

Arm Description

This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.

This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.

Outcomes

Primary Outcome Measures

Mean arterial blood pressure
Mean arterial blood pressure measured in mmHg

Secondary Outcome Measures

Heart rate
Number of heart beats per minute
The number of patients who suffer from post-induction hypotension.
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
Cardiac output
Volume of blood pumped by the heart in one minute measured in liters per minute
Norepinephrine consumption
The total dose of norepinephrine measured in micrograms
Systolic blood pressure
Systolic arterial blood pressure measured in mmHg

Full Information

First Posted
February 15, 2019
Last Updated
November 23, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03844984
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine group
Arm Type
Active Comparator
Arm Description
This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
Arm Title
Lidocaine-ketamine group
Arm Type
Experimental
Arm Description
This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.
Intervention Type
Drug
Intervention Name(s)
ketamine full dose
Other Intervention Name(s)
Ketamine hydrochloride
Intervention Description
This group will receive induction of anesthesia using Ketamine 1 mg/Kg.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
dormicum
Intervention Description
This group will receive midazolam 0.05 mg/Kg
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
This group will receive normal saline 10 mL
Intervention Type
Drug
Intervention Name(s)
ketamine half dose
Other Intervention Name(s)
Ketamine hydrochloride
Intervention Description
This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Lidocaine hydrochloride
Intervention Description
This group will receive lidocaince 1 mg/Kg diluted in 10 mL normal saline.
Primary Outcome Measure Information:
Title
Mean arterial blood pressure
Description
Mean arterial blood pressure measured in mmHg
Time Frame
10 minutes after induction of general anesthesia
Secondary Outcome Measure Information:
Title
Heart rate
Description
Number of heart beats per minute
Time Frame
10 minutes after induction of general anesthesia
Title
The number of patients who suffer from post-induction hypotension.
Description
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
Time Frame
5 minutes after induction of general anesthesia
Title
Cardiac output
Description
Volume of blood pumped by the heart in one minute measured in liters per minute
Time Frame
10 minutes after induction of general anesthesia
Title
Norepinephrine consumption
Description
The total dose of norepinephrine measured in micrograms
Time Frame
10 minutes after induction of general anesthesia
Title
Systolic blood pressure
Description
Systolic arterial blood pressure measured in mmHg
Time Frame
10 minutes after induction of general anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf Rady, Professor
Organizational Affiliation
Head of department of anesthesia, Cairo University, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed Mohamed Hasanin
City
Cairo
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32898698
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.
Results Reference
derived

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

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