NCT02186990

Brief Summary

The purpose of this study is to evaluate the effect of propofol, etomidate and propofol-etomidate combination on hemodynamic responses during laryngoscopy and tracheal intubation and assess the adverse effect related to this drugs.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

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

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

June 6, 2014

Last Update Submit

August 12, 2014

Conditions

Induction of Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • haemodynamic values

    e.g., heart rate, blood pressure (mean arterial pressure)

    in ten minutes after intubation

Secondary Outcomes (1)

  • adverse effect of study drugs

    within in 30 minutes drug administration

Study Arms (3)

propofol

ACTIVE COMPARATOR
Drug: etomidate-propofol

etomidate

ACTIVE COMPARATOR
Drug: etomidate

propofol-etomidate

ACTIVE COMPARATOR
Drug: propofol

Interventions

propofolDRUG

2,5 mg/kg

propofol-etomidate
etomidateDRUG

0,3 mg/kg

etomidate
etomidate-propofolDRUG

0,15 mg/kg etomidate + 1,25 mg/kg propofol

propofol

Eligibility Criteria

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

You may qualify if:

  • between 18 - 65 age
  • ASA I - II status
  • elective surgery

You may not qualify if:

  • emergency surgery
  • pregnancy
  • alcohol and drug abuse
  • HT and cardiovascular disease
  • BMI \> 25 kg/m2
  • hypersensitivity against study drug
  • sedative drug use in last month
  • difficult intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Altinordu, Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

PropofolEtomidate

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 6, 2014

First Posted

July 10, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

TU(1)