UnconsciousnessNCT03290859
Race-Specific Propofol Titration to Effect for Procedural Sedation
An observational study of Unconsciousness and Apnea, Postanesthetic, run by University of Florida at 1 site in United States.
Trial summary
Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial difference in propofol sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unconsciousness, Apnea, Postanesthetic, Sedative Overdose
- What is being tested?
- Titrate propofol monotherapy infusion to effect
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 2,780 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2018to 5 Feb 2019
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI Endoscopy suites
Who may be able to join
- Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI Endoscopy suites
- Age range 18 - 80 years old
- Patients whose race can be identified from the electronic patient information chart (EPIC)
Who cannot join
- Patients who identify as multiracial in Epic
- Patients who identify as Other in Epic
- Patients who refuse to indicate their race in Epic
- Patients whose race is listed as unknown in Epic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Clinical Trial of Race-Specific Response to Propofol Infusion Titrated to Effect for Procedural Sedation During Endoscopy
Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial difference in propofol sensitivity.
Read the detailed description
The primary motivation in conducting this study is to conduct the implementation science, i.e., formalize and train, and retrain if needed, anesthesia providers in the standard practice of titrating infusion rate to effect and clinically evaluate the effect of race and ethnicity on propofol monotherapy sedation during GI endoscopy. The ultimate goal is to make it less likely that patients from races known to be sensitive to propofol experience inadvertent overdosing.
- Conditions
- Unconsciousness, Apnea, Postanesthetic, Sedative Overdose, Hypoxemia
- Being tested
- Titrate propofol monotherapy infusion to effect
- Keywords
- Procedural Sedation
- Medical subject headings
- Unconsciousness, Butyrylcholinesterase deficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titrate propofol monotherapy infusion to effectProcedure or surgery
Train anesthesia providers in a standardized protocol for titrating propofol infusion to effect.
| Study group | Role | What they receive |
|---|---|---|
| Training intervention | Train anesthesia providers who deliver propofol sedation for GI endoscopy procedures to follow a uniform propofol monotherapy administration guideline to titrate propofol monotherapy infusion to effect according to a standardized protocol. Receives: Procedure: Titrate propofol monotherapy infusion to effect | |
| Effectiveness of training intervention | Compare the effectiveness of training intervention and standardized titration to effect through aggregate data for metrics of recovery times. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the recovery times among races and ethnicities
Monitored using aggregate data for metrics of recovery times
Measured: Change from baseline up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start5 Jan 2018
- Primary completion5 Feb 2019
- Study completion5 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UnconsciousnessStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,780 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Jeffrey White, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290859
- Sponsor's protocol ID
- IRB201701064 - N
- Other IDs
- UL1TR001427, OCR18882
- Status last verified
- Oct 2019
- First submitted
- 18 Sep 2017
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Clinical Trial of Race-Specific Response to Propofol Infusion Titrated to Effect for Procedural Sedation During Endoscopy
- ClinicalTrials.gov ID
- NCT03290859
- Acronym / sponsor ID
- IRB201701064 - N
- Conditions
- Unconsciousness, Apnea, Postanesthetic, Sedative Overdose, Hypoxemia
- Keywords
- Procedural Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,780 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 5 Feb 2019 (actual)
- First posted
- 25 Sep 2017 (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.
Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial difference in propofol sensitivity.
Detailed description
The primary motivation in conducting this study is to conduct the implementation science, i.e., formalize and train, and retrain if needed, anesthesia providers in the standard practice of titrating infusion rate to effect and clinically evaluate the effect of race and ethnicity on propofol monotherapy sedation during GI endoscopy. The ultimate goal is to make it less likely that patients from races known to be sensitive to propofol experience inadvertent overdosing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training intervention | – | Procedure: Titrate propofol monotherapy infusion to effectTrain anesthesia providers who deliver propofol sedation for GI endoscopy procedures to follow a uniform propofol monotherapy administration guideline to titrate propofol monotherapy infusion to effect according to a standardized protocol. |
| Effectiveness of training intervention | – | –Compare the effectiveness of training intervention and standardized titration to effect through aggregate data for metrics of recovery times. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI Endoscopy suites
Key inclusion criteria (3 listed)
- Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI Endoscopy suites
- Age range 18 - 80 years old
- Patients whose race can be identified from the electronic patient information chart (EPIC)
Key exclusion criteria (4 listed)
- Patients who identify as multiracial in Epic
- Patients who identify as Other in Epic
- Patients who refuse to indicate their race in Epic
- Patients whose race is listed as unknown in Epic
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 |
|---|---|---|
| Titrate propofol monotherapy infusion to effectTrain anesthesia providers in a standardized protocol for titrating propofol infusion to effect. | Procedure or surgery | Training intervention |
Primary outcome
Change in the recovery times among races and ethnicities
Time frame: Change from baseline up to 24 hours
Monitored using aggregate data for metrics of recovery times
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 25 Oct 2019.
- 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.
Jeffrey White, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unconsciousness and Apnea, Postanesthetic, run by University of Florida 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 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: finished, as of the sponsor's last update on 25 Oct 2019. 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.
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?
Change in the recovery times among races and ethnicities (time frame: Change from baseline up to 24 hours). 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 25 Oct 2019.