Comparison of Etomidate, Propofol and Etomidate-propofol Combination in Terms of Effects on Haemodynamic Response to Intubation

August 12, 2014 updated by: özgür yağan, T.C. ORDU ÜNİVERSİTESİ
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ordu
      • Altınordu, Ordu, Turkey, 52100
        • Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propofol
Drug: etomidate-propofol
0,15 mg/kg etomidate + 1,25 mg/kg propofol
Active Comparator: etomidate
Drug: etomidate
0,3 mg/kg
Active Comparator: propofol-etomidate
Drug: propofol
2,5 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
haemodynamic values
Time Frame: in ten minutes after intubation
e.g., heart rate, blood pressure (mean arterial pressure)
in ten minutes after intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse effect of study drugs
Time Frame: within in 30 minutes drug administration
e.g. myoclonus, injection pain, allergy, skin rash
within in 30 minutes drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T.C. ORDU ÜNİVERSİTESİ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Odu-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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