HypertensionPhase 3NCT01248234
Does Administration of Etomidate and Propofol of the Anesthetic Induction of Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngoscopy When Compared to Propofol or Etomidate Alone?
A Phase 3 study testing propofol, Etomidate and Propofol and Etomidate in people with Hypertension, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
This study will attempt to show that a combination of drugs, Etomidate and Propofol, provide a more stable blood pressure when used to put elderly hypertensive patients to sleep than either drug used alone. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- propofol, Etomidate and Propofol and Etomidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2012
- Phase
- Phase 3
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients at least 65 years old, with a history of hypertension.
Who cannot join
- Patients less than 65 years old or without a history of hypertension.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Does Administration of Etomidate and Propofol if the Anesthetic Induction of the Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngosacopy, When Compared to Propofol or Etomidate Alone?
This study will attempt to show that a combination of drugs, Etomidate and Propofol, provide a more stable blood pressure when used to put elderly hypertensive patients to sleep than either drug used alone.
Read the detailed description
Same as above.
- Conditions
- Hypertension
- Being tested
- propofol, Etomidate, Propofol and Etomidate
- Keywords
- elderly, hypertensive, anesthesia
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Propofol 1mg/kg will be given once to put the patient to sleep for surgery.
EtomidateDrug
Etomidate 0.3mg/kg will be given once to put the patient to sleep for surgery.
Propofol and EtomidateDrug
Etomidate 0.2mg/kg plus Propofol 0.5mg/kg will be given once to put the patient to sleep for surgery.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Propofol alone will be used to put an elderly hypertensive patient to sleep for surgery. Receives: Drug: propofol |
| Etomidate | Active comparator | Etomidate alone will be used to put an elderly hypertensive patient to sleep. Receives: Drug: Etomidate |
| Propofol and Etomidate | Active comparator | A combination of Etomidate and Propofol will be used to put an elderly hypertensive patient to sleep for surgery. Receives: Drug: Propofol and Etomidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure stability during anesthetic induction
Blood pressure will be measures every minute for 15 minutes following anesthetic induction
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startJul 2012
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Why it stopped: Did not begin
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia A Vaughn, MD, Study chair, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248234
- Sponsor's protocol ID
- 2010-0097
- Status last verified
- Jul 2012
- First submitted
- 23 Nov 2010
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Administration of Etomidate and Propofol if the Anesthetic Induction of the Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngosacopy, When Compared to Propofol or Etomidate Alone?
- ClinicalTrials.gov ID
- NCT01248234
- Acronym / sponsor ID
- 2010-0097
- Conditions
- Hypertension
- Keywords
- elderly, hypertensive, anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not begin
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 25 Nov 2010 (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.
This study will attempt to show that a combination of drugs, Etomidate and Propofol, provide a more stable blood pressure when used to put elderly hypertensive patients to sleep than either drug used alone.
Detailed description
Same as above.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: propofolPropofol alone will be used to put an elderly hypertensive patient to sleep for surgery. |
| Etomidate | Active comparator | Drug: EtomidateEtomidate alone will be used to put an elderly hypertensive patient to sleep. |
| Propofol and Etomidate | Active comparator | Drug: Propofol and EtomidateA combination of Etomidate and Propofol will be used to put an elderly hypertensive patient to sleep for surgery. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients at least 65 years old, with a history of hypertension.
Key exclusion criteria (1 listed)
- Patients less than 65 years old or without a history of hypertension.
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 |
|---|---|---|
| propofolPropofol 1mg/kg will be given once to put the patient to sleep for surgery. | Drug | Propofol |
| EtomidateEtomidate 0.3mg/kg will be given once to put the patient to sleep for surgery. | Drug | Etomidate |
| Propofol and EtomidateEtomidate 0.2mg/kg plus Propofol 0.5mg/kg will be given once to put the patient to sleep for surgery. | Drug | Propofol and Etomidate |
Primary outcome
Blood pressure stability during anesthetic induction
Time frame: 15 minutes
Blood pressure will be measures every minute for 15 minutes following anesthetic induction
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
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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.
Cynthia A Vaughn, MD study chair
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing propofol, Etomidate and Propofol and Etomidate in people with Hypertension, run by University of Mississippi Medical Center 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 16 Jul 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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 stability during anesthetic induction (time frame: 15 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 16 Jul 2012.