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

Primary Purpose

Septic Shock, Anesthesia

Status

Unknown status

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Ketamine full dose

Ketamine half dose

Lidocaine

Midazolam

Normal saline

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

Cairo University

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 pressure

Mean arterial pressure measured in mmHg

Secondary Outcome Measures

Heart rate

number of heart beats per minutes

Cardiac output

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

The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia

Norepinephrine consumption

The total dose of norepinephrine measured in micrograms

Full Information

NCT ID

NCT03640468

First Posted

August 18, 2018

Last Updated

November 20, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03640468

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 20, 2018 (Anticipated)

Primary Completion Date

June 15, 2019 (Anticipated)

Study Completion Date

July 1, 2019 (Anticipated)

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

Studies a U.S. FDA-regulated Device Product

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, Anesthesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

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)

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

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

Primary Outcome Measure Information:

Title

Mean arterial pressure

Description

Mean arterial 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 minutes

Time Frame

10 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

The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Amin, Lecturer

Phone

+201227476617

sarahamin_22@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Hasanin, Professor

Organizational Affiliation

Assistant professor of anesthesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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