NCT03251170

Brief Summary

The aim of this work is to compare two protocols (ketamine-midazolam versus fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find the most safe protocol with regards to hemodynamic status of patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2018

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

August 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

August 12, 2017

Last Update Submit

January 25, 2020

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

  • Mean arterial pressure

    Mean arterial blood pressure measured by invasive transducer attached to arterial catheter

    30 minutes after induction of anesthesia

Secondary Outcomes (7)

  • cardiac output

    30 minutes after induction of anesthesia

  • Stroke volume

    30 minutes after induction of anesthesia

  • heart rate

    30 minutes after induction of anesthesia

  • serum lactate

    30 minutes after induction of anesthesia

  • total norepinephrine dose

    30 minutes after induction of anesthesia

  • +2 more secondary outcomes

Study Arms (2)

Ketamine group

EXPERIMENTAL

This group of patients will receive: 1 mg/Kg ketamine + 0.05 mg/Kg midazolam for induction of anesthesia. Endotracheal tube will be inserted aided by 1 mg/Kg succinyl choline. Patients will undergo surgical procedure to eliminate the source of sepsis e.g. abdominal exploration. Invasive blood pressure monitor will be connected to the patient through an arterial catheter. Electrical velocimetry (cardiometry) device will be connected to the patient to measure cardiac output, stroke volume, and systemic vascular resistance.

Drug: KetamineDrug: Midazolam

Fentanyl

ACTIVE COMPARATOR

2.5 mg/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia. Endotracheal tube will be inserted aided by 1 mg/Kg succinyl choline. Patients will undergo surgical procedure to eliminate the source of sepsis e.g. abdominal exploration. Invasive blood pressure monitor will be connected to the patient through an arterial catheter. Electrical velocimetry (cardiometry) device will be connected to the patient to measure cardiac output, stroke volume, and systemic vascular resistance.

Drug: FentanylDrug: Midazolam

Interventions

KetamineDRUG

Patients will receive :1 mg/Kg ketamine for induction of anesthesia

Also known as: Katalar
Ketamine group
FentanylDRUG

Patients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia

Fentanyl
MidazolamDRUG

Patients will receive 0.05 mg/Kg midazolam

Also known as: Dormicum
FentanylKetamine group

Eligibility Criteria

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

You may qualify if:

  • Sepsis patients
  • With shock index (heart rate divided by systolic blood pressure) \>0.7. or Sepsis patients with norepinephrine infusion.

You may not qualify if:

  • Traumatic brain injury
  • Cerebrovascular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

KetamineFentanylMidazolam

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ahmed Mukhtar

    Head of research committee section in anesthesia department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
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

Study Record Dates

First Submitted

August 12, 2017

First Posted

August 16, 2017

Study Start

January 25, 2018

Primary Completion

December 25, 2019

Study Completion

December 30, 2019

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)