SurgeryPhase 4NCT03820388
Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia
A Phase 4 study testing Propofol 2mg/kg, Etomidate 0.3 mg/kg and Propofol 1 mg/kg in people with Surgery, run by University of California, Davis at 1 site in United States.
Trial summary
Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Propofol 2mg/kg, Etomidate 0.3 mg/kg and Propofol 1 mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 13 Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective non-cardiac surgery
- ASA physical status of 2 or 3
- Age equal to or greater than 18 years old
Who cannot join
- Adults unable to provide consent
- Age less than 18 years old
- Pregnant women
- Prisoners
- Difficult airway
- Morbid Obesity
Show all 11Show fewer
- Preoperative sedation use
- Severe Cardiac, pulmonary and liver disease
- Hypotension and shock
- Emergency surgeries
- Allergy to propofol or etomidate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia.
Read the detailed description
Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia. The specific aims are testing patient reactions during induction, and in the post-anesthesia care unit (PACU).
- Conditions
- Surgery
- Being tested
- Propofol 2mg/kg, Etomidate 0.3 mg/kg, Propofol 1 mg/kg, Etomidate 0.15 mg/kg
- Keywords
- Etomidate, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol 2mg/kgDrug
Also called Diprivan
2 mg/kg
Etomidate 0.3 mg/kgDrug
Also called Amidate
0.3 mg/kg
Propofol 1 mg/kgDrug
Also called Diprivan
1 mg/kg Propofol
Etomidate 0.15 mg/kgDrug
Also called Amidate
0.15 mg/kg Etomidate
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | Experimental | Propofol 2 mg/kg Receives: Drug: Propofol 2mg/kg |
| Etomidate Group | Experimental | Etomidate 0.3 mg/kg Receives: Drug: Etomidate 0.3 mg/kg |
| Propofol plus Etomidate Group | Experimental | Propofol 1 mg/kg plus Etomidate 0.15 mg/kg Receives: Drug: Propofol 1 mg/kg; Drug: Etomidate 0.15 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.
Measured: 10 minutes after induction (intraoperative)
Heart Rate
Heart Rate changes during induction (Beats Per min)
Measured: 10 minutes after induction (intraoperative)
Secondary outcomes (6)
Pain at Injection Site
Pain on injection will be measured using 4 graded scale; 0 = no pain, 1 = verbal complaint of pain, 2 = withdrawal of arm, 3 = both verbal complaint and withdrawal of arm.
Measured: intraoperative
Myoclonic Movements
The incidence and degree of myoclonic movements also recorded as follows: 0 = no myoclonic movements, 1 = minor myoclonic movements, 2 = moderate myoclonic movements, 3 = major myoclonic movements.
Measured: intraoperative
Post-operative Nausea and Vomiting
Presence of post-operative nausea or vomiting (yes/no).
Measured: 24 hours post-operation
Sedation Depth
Sedation depth using bispectral index (BIS). BIS scores range from 0-100. A value of 0 indicates no EEG activity, 40-60 indicates an appropriate level of general anesthesia, and 90-100 is typical of a state of wakefulness.
Measured: 30 minutes post-induction
Eyelash Reflex Disappear Time
Time to disappearance of eyelash reflex after induction.
Measured: Post induction, up to 1 hour
Intubation Time
Duration of orotracheal intubation.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Dec 2017
- Primary completion13 Jul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in 3 cohorts will be administered 30 second bolus by manual hand push
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Liu, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820388
- Sponsor's protocol ID
- 909765
- Status last verified
- Feb 2021
- First submitted
- 9 Jan 2018
- Last updated
- 23 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia
- ClinicalTrials.gov ID
- NCT03820388
- Acronym / sponsor ID
- 909765
- Conditions
- Surgery
- Keywords
- Etomidate, Propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia.
Detailed description
Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia. The specific aims are testing patient reactions during induction, and in the post-anesthesia care unit (PACU).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Patients in 3 cohorts will be administered 30 second bolus by manual hand push
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | Experimental | Drug: Propofol 2mg/kgPropofol 2 mg/kg |
| Etomidate Group | Experimental | Drug: Etomidate 0.3 mg/kgEtomidate 0.3 mg/kg |
| Propofol plus Etomidate Group | Experimental | Drug: Propofol 1 mg/kg, Drug: Etomidate 0.15 mg/kgPropofol 1 mg/kg plus Etomidate 0.15 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective non-cardiac surgery
- ASA physical status of 2 or 3
- Age equal to or greater than 18 years old
Key exclusion criteria (11 listed)
- Adults unable to provide consent
- Age less than 18 years old
- Pregnant women
- Prisoners
- Difficult airway
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 |
|---|---|---|
| Propofol 2mg/kgAlso: Diprivan2 mg/kg | Drug | Propofol Group |
| Etomidate 0.3 mg/kgAlso: Amidate0.3 mg/kg | Drug | Etomidate Group |
| Propofol 1 mg/kgAlso: Diprivan1 mg/kg Propofol | Drug | Propofol plus Etomidate Group |
| Etomidate 0.15 mg/kgAlso: Amidate0.15 mg/kg Etomidate | Drug | Propofol plus Etomidate Group |
Primary outcome
Blood Pressure
Time frame: 10 minutes after induction (intraoperative)
Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.
Heart Rate
Time frame: 10 minutes after induction (intraoperative)
Heart Rate changes during induction (Beats Per min)
6 secondary outcomes
Pain at Injection Site
Time frame: intraoperative
Myoclonic Movements
Time frame: intraoperative
Post-operative Nausea and Vomiting
Time frame: 24 hours post-operation
Sedation Depth
Time frame: 30 minutes post-induction
Eyelash Reflex Disappear Time
Time frame: Post induction, up to 1 hour
Intubation Time
Time frame: Up to 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Hong Liu, MD principal investigator
University of California, Davis
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 2mg/kg, Etomidate 0.3 mg/kg and Propofol 1 mg/kg in people with Surgery, run by University of California, Davis at 1 site in United States.
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 11 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 23 Feb 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Pressure (time frame: 10 minutes after induction (intraoperative)). The study lists 2 primary outcomes in all. 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 23 Feb 2021.