NCT03640468

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

August 18, 2018

Last Update Submit

November 20, 2018

Conditions

Septic ShockAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Mean arterial pressure

    Mean arterial pressure measured in mmHg

    10 minutes after induction of general anesthesia

Secondary Outcomes (4)

  • Heart rate

    10 minutes after induction of general anesthesia

  • Cardiac output

    10 minutes after induction of general anesthesia

  • 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

  • Norepinephrine consumption

    10 minutes after induction of general anesthesia

Study Arms (2)

Ketamine group

ACTIVE COMPARATOR

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

Drug: Ketamine full doseDrug: MidazolamDrug: Normal saline

Lidocaine-ketamine group

EXPERIMENTAL

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.

Drug: Ketamine half doseDrug: LidocaineDrug: Midazolam

Interventions

Ketamine full doseDRUG

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

Also known as: Ketamine hydrochloride
Ketamine group
Ketamine half doseDRUG

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

Also known as: Ketamine Hydrochloride
Lidocaine-ketamine group
LidocaineDRUG

This group will receive lidocaince 1 mg/Kg

Also known as: Lidocaine Hydrochloride
Lidocaine-ketamine group
MidazolamDRUG

This group will receive midazolam 0.05 mg/Kg

Also known as: Dormicum
Ketamine groupLidocaine-ketamine group
Normal salineDRUG

This group will receive normal saline 10 mL

Ketamine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients under 18 years
  • Burn patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

KetamineLidocaineMidazolamSaline Solution

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAminesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ahmed Hasanin, Professor

    Assistant professor of anesthesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Amin, Lecturer

CONTACT

+201227476617sarahamin_22@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of anesthesia and critical care

Study Record Dates

First Submitted

August 18, 2018

First Posted

August 21, 2018

Study Start

December 20, 2018

Primary Completion

June 15, 2019

Study Completion

July 1, 2019

Last Updated

November 21, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)