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Completed

NCT Number: NCT04987580

Efficacy and Safety of a Single Syringe Total Intravenous Anesthesia With Propofol and Remifentanil: A Prospective Cohort 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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

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 (unpublished data) This retrospective analysis, was used to identify adverse events, which included: awareness during surgery, significant vasopressor use, replacement of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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • True allergy to propofol/remifentanil
  • Inability to understand pain scores and other questionnaires
  • Inability to speak English
  • Emergency surgery

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Hemodynamic Instability

    Time frame: during the surgery

    Blood pressure readings will be recorded

  2. Incidence of vasoactive dosage

    Time frame: during the surgery

    Vasoactive agent use will be recorded

  3. Intra-operative movement

    Time frame: during the surgery

    Intra-operative movement will be recorded during the surgery

  4. Time to emergence

    Time frame: during the surgery

    Time to emergence from anesthesia will be recorded during the surgery

  5. Anesthesia provider team

    Time frame: Immediately following the surgery

    Anesthesia provider(s) (i.e. anesthetist attending, CRNA, resident) will be recorded.

  6. Post-operative nausea

    Time frame: 0, 15, 30, and 45 minutes after the surgery

    Post-operative nausea will be recorded

  7. Post-operative vomiting

    Time frame: 0, 15, 30, and 45 minutes after the surgery

    Post-operative vomiting will be recorded

  8. Awareness with recall

    Time frame: 30 minutes and 1 day after the surgery

    Awareness will be assessed using the structured interview

  9. Post-operative delirium

    Time frame: 45 minutes after the surgery

    Post-operative delirium will be recorded using the Nursing Delirium Screening Scale (0-mild (positive outcome), 1-moderate, 2-severe (poor outcome)).

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2021
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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