TraumaNCT04120870
Comparison of Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients
A study testing Etomidate Injection 0.2 mg/kg and Ketamine injection 2 mg/kg in people with Trauma and Shock, Traumatic, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
In trauma patients with high shock index, the investigators compare the effects on hemodynamics between ketamine and etomidate. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Trauma, Shock, Traumatic
- What is being tested?
- Etomidate Injection 0.2 mg/kg and Ketamine injection 2 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2019to 30 Dec 2021
- Phase
- Interventional
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 19~70
- Shock index ≥ 0.9
- Patients who need intubation regarding to Ajou trauma center protocol
Who cannot join
- during CPR
- CPR before hospital arrival
- Severe head trauma
- Steroid intake history
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou university school of medicine
Suwon, Gyeonggi-do, 16499
About this study
Official title: Comparison of Effects on Hemodynamics Between Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients With High Shock Index
In trauma patients with high shock index, the investigators compare the effects on hemodynamics between ketamine and etomidate.
Read the detailed description
In trauma patients, rapid sequence intubation is recommended. The drug of choice, however, has been debated. One cohort comparative study showed ketamine had benefit in hemodynamics compared to etomidate in trauma patients. One observational study showed in high shock index patients, ketamine showed maintain systolic blood pressure. And other retrospective showed less clinical hypotension was less in ketamine. However there is no randomized controlled study comparing ketamine and etomidate in trauma patients. The purpose of this study is comparing the effects of hemodynamics between ketamine and etomidate in high shock index trauma patients.
- Conditions
- Trauma, Shock, Traumatic
- Being tested
- Etomidate Injection 0.2 mg/kg, Ketamine injection 2 mg/kg
- Keywords
- etomidate, ketamine, rapid sequence intubation, trauma, hemodynamics
- Medical subject headings
- Wounds and Injuries, Shock, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etomidate Injection 0.2 mg/kgDrug
Also called Etomidate
The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
Ketamine injection 2 mg/kgDrug
Also called Ketamine
The induction agent of rapid sequence intubation is ketamine. 2 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Etomidate | Active comparator | The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg Receives: Drug: Etomidate Injection 0.2 mg/kg |
| Ketamine | Experimental | The induction agent of rapid sequence intubation is ketamine. 2 mg/kg Receives: Drug: Ketamine injection 2 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure difference compared with baseline after 10 minutes
Systolic blood pressure 10 minutes after induction agent injection - baseline systolic blood pressure mmHg Positive or zero value means good result. Negative value means poor result.
Measured: 13 minutes
Secondary outcomes (3)
Intubating condition
Intubator judge intubating condition Laryngoscopy: easy / fair / difficult (difficult is the worst result) Vocal cords position: abducted / moving / closed (closed is the worst result) Reaction to insertion of the tracheal tube and cuff inflation : none / slight / vigorous (none is the worst result)
If one of category checked the worst score, it considered :clinically unacceptable".
Measured: 5 minutes
Incidence of hypotension
If any of these are checked, define as hypotension (from injection of induction agent to 20 minutes after)
- systolic pressure < 90 mmHg
- systolic pressure decrease > 40% compared to baseline
- Initiation of vasopressor
- Vasopressor dose increase > 30% of initial vaopressor dose
- Fluid or blood loading
Patient numbers (%)
Measured: 25 minutes
Incidence of hypertension
From injection of induction agent to 20 minutes after, systolic pressure > 160 mmHg defined as hypertension
Patients numbers (%)
Measured: 25 miinutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Oct 2019
- Primary completion30 Nov 2021
- Study completion30 Dec 2021
Why it stopped: Due to difficulties in obtaining consent because of emergency situation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ketamine group: ketamine 2 mg/kg iv as induction agent etomidate group: etomidate 0.2 mg/kg iv as induction agent
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Unimedics (http://unimedics.co.kr)
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- In Kyong Yi, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120870
- Sponsor's protocol ID
- MED-OBS-19-294
- Status last verified
- Feb 2022
- First submitted
- 26 Sep 2019
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If there is a reasonable request, we can share the data personally.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects on Hemodynamics Between Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients With High Shock Index
- ClinicalTrials.gov ID
- NCT04120870
- Acronym / sponsor ID
- MED-OBS-19-294
- Conditions
- Trauma, Shock, Traumatic
- Keywords
- etomidate, ketamine, rapid sequence intubation, trauma, hemodynamics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulties in obtaining consent because of emergency situation
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- Unimedics (http://unimedics.co.kr)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 9 Oct 2019 (actual)
- 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.
In trauma patients with high shock index, the investigators compare the effects on hemodynamics between ketamine and etomidate.
Detailed description
In trauma patients, rapid sequence intubation is recommended. The drug of choice, however, has been debated. One cohort comparative study showed ketamine had benefit in hemodynamics compared to etomidate in trauma patients. One observational study showed in high shock index patients, ketamine showed maintain systolic blood pressure. And other retrospective showed less clinical hypotension was less in ketamine. However there is no randomized controlled study comparing ketamine and etomidate in trauma patients. The purpose of this study is comparing the effects of hemodynamics between ketamine and etomidate in high shock index trauma patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ketamine group: ketamine 2 mg/kg iv as induction agent etomidate group: etomidate 0.2 mg/kg iv as induction agent
| Arm | Type | Receives |
|---|---|---|
| Etomidate | Active comparator | Drug: Etomidate Injection 0.2 mg/kgThe induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg |
| Ketamine | Experimental | Drug: Ketamine injection 2 mg/kgThe induction agent of rapid sequence intubation is ketamine. 2 mg/kg |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 19~70
- Shock index ≥ 0.9
- Patients who need intubation regarding to Ajou trauma center protocol
Key exclusion criteria (4 listed)
- during CPR
- CPR before hospital arrival
- Severe head trauma
- Steroid intake history
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 |
|---|---|---|
| Etomidate Injection 0.2 mg/kgAlso: EtomidateThe induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg | Drug | Etomidate |
| Ketamine injection 2 mg/kgAlso: KetamineThe induction agent of rapid sequence intubation is ketamine. 2 mg/kg | Drug | Ketamine |
Primary outcome
Systolic blood pressure difference compared with baseline after 10 minutes
Time frame: 13 minutes
Systolic blood pressure 10 minutes after induction agent injection - baseline systolic blood pressure mmHg Positive or zero value means good result. Negative value means poor result.
3 secondary outcomes
Intubating condition
Time frame: 5 minutes
Incidence of hypotension
Time frame: 25 minutes
Incidence of hypertension
Time frame: 25 miinutes
Results and safety
The study was stopped early (reason given: Due to difficulties in obtaining consent because of emergency situation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No. If there is a reasonable request, we can share the data personally.
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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.
In Kyong Yi, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etomidate Injection 0.2 mg/kg and Ketamine injection 2 mg/kg in people with Trauma and Shock, Traumatic, run by Ajou University School of Medicine at 1 site in South Korea.
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 4 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: stopped early, as of the sponsor's last update on 3 Mar 2022. 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 South Korea. 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.
Are results available for this study?
The study was stopped early (reason given: Due to difficulties in obtaining consent because of emergency situation). Results are not available in the source record.
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?
Systolic blood pressure difference compared with baseline after 10 minutes (time frame: 13 minutes). 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 3 Mar 2022.