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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02186990
Other study ID # Odu-2
Secondary ID
Status Completed
Phase Phase 4
First received June 6, 2014
Last updated August 12, 2014
Start date May 2014

Study information

Verified date August 2014
Source T.C. ORDU ÜNIVERSITESI
Contact n/a
Is FDA regulated No
Health authority Turkey: Drug and Medical Device Institution
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
propofol
2,5 mg/kg
etomidate
0,3 mg/kg
etomidate-propofol
0,15 mg/kg etomidate + 1,25 mg/kg propofol

Locations

Country Name City State
Turkey Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital Altinordu Ordu

Sponsors (1)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary haemodynamic values e.g., heart rate, blood pressure (mean arterial pressure) in ten minutes after intubation No
Secondary adverse effect of study drugs e.g. myoclonus, injection pain, allergy, skin rash within in 30 minutes drug administration No
See also
  Status Clinical Trial Phase
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Completed NCT00506246 - Efficacy and Safety Study of Two Propofol Formulations Phase 3
Completed NCT05294679 - Explore the Clinical Application Value of Ciprofol in Painless Colonoscopy N/A
Completed NCT02287181 - A Phase IV Study Investigating the Effects of Remifentanil Concentrations on Propofol Requirements for Loss of Consciousness, Response to Painful Stimuli, Bispectral Index and Associated Haemodynamic Changes Phase 4