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.

Study Overview

• Status: Completed
• Conditions: Anesthesia

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 (unpublished data) This retrospective analysis, was used to identify adverse events, which included: awareness during surgery, significant vasopressor use, replacement of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 Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to an orthopedic surgery center for elective surgery.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Single Syringe TIVA	Duration of time that processed EEG values are within acceptable limits during maintenance of anesthesia	during the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to emergence	Time to emergence from anesthesia will be recorded during the surgery	during the surgery
Post-operative nausea	Post-operative nausea will be recorded	0, 15, 30, and 45 minutes after the surgery
Awareness with recall	Awareness will be assessed using the structured interview	30 minutes and 1 day after the surgery
Hemodynamic Instability	Blood pressure readings will be recorded	during the surgery
Incidence of vasoactive dosage	Vasoactive agent use will be recorded	during the surgery
Intra-operative movement	Intra-operative movement will be recorded during the surgery	during the surgery
Anesthesia provider team	Anesthesia provider(s) (i.e. anesthetist attending, CRNA, resident) will be recorded.	Immediately following the surgery
Post-operative vomiting	Post-operative vomiting will be recorded	0, 15, 30, and 45 minutes 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)).	45 minutes after the surgery

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 1, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Single Syringe TIVA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No