AnesthesiaNCT04987580
Efficacy and Safety of a Single Syringe Total Intravenous Anesthesia With Propofol and Remifentanil: A Prospective Cohort Study
An observational study of Anesthesia, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this prospective observational study was to evaluate the efficacy and safety of single syringe TIVA with propofol and remifentanil. The primary outcome for efficacy was a processed EEG (pEEG) index within the recommended range for general anesthesia for the duration of the maintenance anesthetic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 Jun 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to an orthopedic surgery center for elective surgery.
Who may be able to join
- age 18 - 75
- Elective orthopedic surgery patients for whom the use of propofol (10 mg/ml) in combination with remifentanil (20 mcg/ml) used in a single syringe in indicated
Who cannot join
- True allergy to propofol/remifentanil
- Inability to understand pain scores and other questionnaires
- Inability to speak English
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this prospective observational study was to evaluate the efficacy and safety of single syringe TIVA with propofol and remifentanil. The primary outcome for efficacy was a processed EEG (pEEG) index within the recommended range for general anesthesia for the duration of the maintenance anesthetic. The primary outcome measure for safety was intraoperative administration of vasopressors. We hypothesized that the pEEG index would be within the recommended range for over 90% of the duration of the maintenance anesthetic. We hypothesized that vasopressor use would be consistent with other anesthetic types using potent inhaled agents.
Read the detailed description
Total intravenous anesthesia (TIVA) is a commonly used general anesthetic. Propofol and remifentanil is a common drug combination used in TIVA and is a safe and efficacious method of anesthesia in pediatric and adult patients.[1-7] A typical TIVA method is to administer each drug using a separate syringe pump. Another approach to TIVA is to use a single syringe pump containing propofol and remifentanil. This approach is considered off-label as neither drug has been approved by a national or international regulatory agency to be used in a single syringe.
The efficacy and safety of single syringe TIVA has not yet been evaluated. At a single university hospital center, single syringe TIVA with propofol and remifentanil has been used for over 15 years for a variety of procedures. A common combination of propofol and remifentanil in a single syringe is propofol 10 mg/ml and remifentanil 20 mcg/ml.
A preliminary retrospective analysis of electronic medical records (Epic Hyperspace Electronic Medical Record, Epic Systems Corporation, Verona, Wisconsin) from May of 2014 to June of 2019 identified 21,985 procedures using single syringe TIVA. (unpublished data) This retrospective analysis, was used to identify adverse events, which included: awareness during surgery, significant vasopressor use, replacement of the single syringe TIVA with an inhaled anesthetic, and patient injury or death. This analysis was limited by possible clinician underreporting of vasopressor use, changes in TIVA infusion rates, and awareness events.
The purpose of this prospective observational study was to evaluate the efficacy and safety of single syringe TIVA with propofol and remifentanil. The primary outcome for efficacy was a processed EEG (pEEG) index within the recommended range for general anesthesia for the duration of the maintenance anesthetic. The primary outcome measure for safety was intraoperative administration of vasopressors. We hypothesized that the pEEG index would be within the recommended range for over 90% of the duration of the maintenance anesthetic. We hypothesized that vasopressor use would be consistent with other anesthetic types using potent inhaled agents.
- Conditions
- Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Single Syringe TIVA
Duration of time that processed EEG values are within acceptable limits during maintenance of anesthesia
Measured: during the surgery
Secondary outcomes (9)
Hemodynamic Instability
Blood pressure readings will be recorded
Measured: during the surgery
Incidence of vasoactive dosage
Vasoactive agent use will be recorded
Measured: during the surgery
Intra-operative movement
Intra-operative movement will be recorded during the surgery
Measured: during the surgery
Time to emergence
Time to emergence from anesthesia will be recorded during the surgery
Measured: during the surgery
Anesthesia provider team
Anesthesia provider(s) (i.e. anesthetist attending, CRNA, resident) will be recorded.
Measured: Immediately following the surgery
Post-operative nausea
Post-operative nausea will be recorded
Measured: 0, 15, 30, and 45 minutes after the surgery
Post-operative vomiting
Post-operative vomiting will be recorded
Measured: 0, 15, 30, and 45 minutes after the surgery
Awareness with recall
Awareness will be assessed using the structured interview
Measured: 30 minutes and 1 day after the surgery
Post-operative delirium
Post-operative delirium will be recorded using the Nursing Delirium Screening Scale (0-mild (positive outcome), 1-moderate, 2-severe (poor outcome)).
Measured: 45 minutes after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987580
- Sponsor's protocol ID
- Single Syringe TIVA
- Status last verified
- Jul 2023
- First submitted
- 22 Jul 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bennion N, Brower TS, Ballard CR, Steenblik J, Lee KH, Egan TD, Swenson JD, Pace NL, Johnson KB. Single-Syringe Total Intravenous Anesthesia With Propofol and Remifentanil: A Prospective Cohort Study. Anesth Analg. 2025 Dec 1;141(6):1230-1233. doi: 10.1213/ANE.0000000000007581. Epub 2025 Jun 2. No abstract available.
PubMed 40455662
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Single Syringe Total Intravenous Anesthesia With Propofol and Remifentanil: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04987580
- Acronym / sponsor ID
- Single Syringe TIVA
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 Aug 2021 (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.
The purpose of this prospective observational study was to evaluate the efficacy and safety of single syringe TIVA with propofol and remifentanil. The primary outcome for efficacy was a processed EEG (pEEG) index within the recommended range for general anesthesia for the duration of the maintenance anesthetic. The primary outcome measure for safety was intraoperative administration of vasopressors. We hypothesized that the pEEG index would be within the recommended range for over 90% of the duration of the maintenance anesthetic. We hypothesized that vasopressor use would be consistent with other anesthetic types using potent inhaled agents.
Detailed description
Total intravenous anesthesia (TIVA) is a commonly used general anesthetic. Propofol and remifentanil is a common drug combination used in TIVA and is a safe and efficacious method of anesthesia in pediatric and adult patients.[1-7] A typical TIVA method is to administer each drug using a separate syringe pump. Another approach to TIVA is to use a single syringe pump containing propofol and remifentanil. This approach is considered off-label as neither drug has been approved by a national or international regulatory agency to be used in a single syringe.
The efficacy and safety of single syringe TIVA has not yet been evaluated. At a single university hospital center, single syringe TIVA with propofol and remifentanil has been used for over 15 years for a variety of procedures. A common combination of propofol and remifentanil in a single syringe is propofol 10 mg/ml and remifentanil 20 mcg/ml.
A preliminary retrospective analysis of electronic medical records (Epic Hyperspace Electronic Medical Record, Epic Systems Corporation, Verona, Wisconsin) from May of 2014 to June of 2019 identified 21,985 procedures using single syringe TIVA. (unpublished data) This retrospective analysis, was used to identify adverse events, which included: awareness during surgery, significant vasopressor use, replacement of the single syringe TIVA with an inhaled anesthetic, and patient injury or death. This analysis was limited by possible clinician underreporting of vasopressor use, changes in TIVA infusion rates, and awareness events.
The purpose of this prospective observational study was to evaluate the efficacy and safety of single syringe TIVA with propofol and remifentanil. The primary outcome for efficacy was a processed EEG (pEEG) index within the recommended range for general anesthesia for the duration of the maintenance anesthetic. The primary outcome measure for safety was intraoperative administration of vasopressors. We hypothesized that the pEEG index would be within the recommended range for over 90% of the duration of the maintenance anesthetic. We hypothesized that vasopressor use would be consistent with other anesthetic types using potent inhaled agents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to an orthopedic surgery center for elective surgery.
Key inclusion criteria (2 listed)
- age 18 - 75
- Elective orthopedic surgery patients for whom the use of propofol (10 mg/ml) in combination with remifentanil (20 mcg/ml) used in a single syringe in indicated
Key exclusion criteria (4 listed)
- True allergy to propofol/remifentanil
- Inability to understand pain scores and other questionnaires
- Inability to speak English
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of Single Syringe TIVA
Time frame: during the surgery
Duration of time that processed EEG values are within acceptable limits during maintenance of anesthesia
9 secondary outcomes
Hemodynamic Instability
Time frame: during the surgery
Incidence of vasoactive dosage
Time frame: during the surgery
Intra-operative movement
Time frame: during the surgery
Time to emergence
Time frame: during the surgery
Anesthesia provider team
Time frame: Immediately following the surgery
Post-operative nausea
Time frame: 0, 15, 30, and 45 minutes after the surgery
Post-operative vomiting
Time frame: 0, 15, 30, and 45 minutes after the surgery
Awareness with recall
Time frame: 30 minutes and 1 day after the surgery
Post-operative delirium
Time frame: 45 minutes after the surgery
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 1 Aug 2023.
- Derived from this study: PubMed 40455662Bennion N, Brower TS, Ballard CR, Steenblik J, Lee KH, Egan TD, Swenson JD, Pace NL, Johnson KB. Single-Syringe Total Intravenous Anesthesia With Propofol and Remifentanil: A Prospective Cohort Study. Anesth Analg. 2025 Dec 1;141(6):1230-1233. doi: 10.1213/ANE.0000000000007581. Epub 2025 Jun 2. No abstract available.
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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?
An observational study of Anesthesia, run by University of Utah 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 2 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 1 Aug 2023. 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?
Efficacy of Single Syringe TIVA (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04987580, which also lists 1 linked publication.
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 1 Aug 2023.