Comparison of Etomidate, Propofol and Etomidate-propofol... | NCT02186990

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

NCT02186990

Sponsor

Ordu University

Status

Completed

Last Update Posted

Aug 13, 2014Estimated

Enrollment

90Actual

Phase

Phase 4

Conditions

Induction of Anaesthesia

Interventions

propofol
etomidate
etomidate-propofol

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Not provided

First Submitted Date

Jun 6, 2014

First Submission Date that Met QC Criteria

Jul 7, 2014

First Posted Date

Jul 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2014

Last Update Posted Date

Aug 13, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
propofol	Active Comparator	Drug: etomidate-propofol
etomidate	Active Comparator	Drug: etomidate
propofol-etomidate	Active Comparator	Drug: propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
propofol	Drug	2,5 mg/kg	propofol-etomidate
etomidate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital		Altinordu	Ordu	52100	Turkey (Türkiye)

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D005045	Etomidate

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided