NCT03844984

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

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

February 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

February 15, 2019

Last Update Submit

November 23, 2019

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

  • Mean arterial blood pressure

    Mean arterial blood pressure measured in mmHg

    10 minutes after induction of general anesthesia

Secondary Outcomes (5)

  • Heart rate

    10 minutes after induction of general anesthesia

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

    5 minutes after induction of general anesthesia

  • Cardiac output

    10 minutes after induction of general anesthesia

  • Norepinephrine consumption

    10 minutes after induction of general anesthesia

  • Systolic blood pressure

    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: MidazolamDrug: ketamine half doseDrug: Lidocaine

Interventions

ketamine full doseDRUG

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

Also known as: Ketamine hydrochloride
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
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 diluted in 10 mL normal saline.

Also known as: Lidocaine hydrochloride
Lidocaine-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)

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 32898698DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

KetamineMidazolamSaline SolutionLidocaine

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Ashraf Rady, Professor

    Head of department of anesthesia, Cairo University, Egypt

    STUDY CHAIR

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

February 15, 2019

First Posted

February 19, 2019

Study Start

February 20, 2019

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)