Induction of AnaesthesiaPhase 4NCT02186990
Comparison of Etomidate, Propofol and Etomidate-propofol Combination in Terms of Effects on Haemodynamic Response to Intubation
A Phase 4 study testing propofol, etomidate and etomidate-propofol in people with Induction of Anaesthesia, run by Ordu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Induction of Anaesthesia
- What is being tested?
- propofol, etomidate and etomidate-propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2014to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 - 65 age
- ASA I - II status
- elective surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
Altinordu, Ordu, 52100
About this study
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.
- Conditions
- Induction of Anaesthesia
- Being tested
- propofol, etomidate, etomidate-propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
2,5 mg/kg
etomidateDrug
0,3 mg/kg
etomidate-propofolDrug
0,15 mg/kg etomidate + 1,25 mg/kg propofol
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | Not described Receives: Drug: etomidate-propofol |
| etomidate | Active comparator | Not described Receives: Drug: etomidate |
| propofol-etomidate | Active comparator | Not described Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
haemodynamic values
e.g., heart rate, blood pressure (mean arterial pressure)
Measured: in ten minutes after intubation
Secondary outcomes (1)
adverse effect of study drugs
e.g. myoclonus, injection pain, allergy, skin rash
Measured: within in 30 minutes drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özgür yağan, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186990
- Sponsor's protocol ID
- Odu-2
- Status last verified
- Aug 2014
- First submitted
- 6 Jun 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Etomidate, Propofol and Etomidate-propofol Combination in Terms of Effects on Haemodynamic Response to Intubation
- ClinicalTrials.gov ID
- NCT02186990
- Acronym / sponsor ID
- Odu-2
- Conditions
- Induction of Anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: etomidate-propofol |
| etomidate | Active comparator | Drug: etomidate |
| propofol-etomidate | Active comparator | Drug: propofol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 18 - 65 age
- ASA I - II status
- elective surgery
Key exclusion criteria (8 listed)
- emergency surgery
- pregnancy
- alcohol and drug abuse
- HT and cardiovascular disease
- BMI > 25 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol2,5 mg/kg | Drug | propofol-etomidate |
| etomidate0,3 mg/kg | Drug | etomidate |
| etomidate-propofol0,15 mg/kg etomidate + 1,25 mg/kg propofol | Drug | propofol |
Primary outcome
haemodynamic values
Time frame: in ten minutes after intubation
e.g., heart rate, blood pressure (mean arterial pressure)
1 secondary outcome
adverse effect of study drugs
Time frame: within in 30 minutes drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol, etomidate and etomidate-propofol in people with Induction of Anaesthesia, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
haemodynamic values (time frame: in ten minutes after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.