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

Sponsor

University of Utah (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04987580

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
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 (unpublished data) This retrospective analysis, was used to identify adverse events, which included: awareness during surgery, significant vasopressor use, replacement of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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Outcome Measures

Primary Outcome Measures

Safety of Single Syringe TIVA [during the surgery]
Vasoactive agent use
Efficacy of Single Syringe TIVA [during the surgery]
Duration of time that processed EEG values are within acceptable limits during maintenance of anesthesia

Secondary Outcome Measures

Bolus dosing of the propofol and remifentanil combination, [during the surgery]
Bolus dosing of the propofol and remifentanil combination will be recorded during the surgery
Suppression ratio [during the surgery]
The suppression ratio during maintenance of anesthesia will be recorded
Time to emergence [during the surgery]
Time to emergence from anesthesia will be recorded during the surgery
Post-operative pain [0, 15, 30, and 45 minutes after the surgery]
Post-operative pain will be recorded
Post-operative nausea [0, 15, 30, and 45 minutes after the surgery]
Post-operative nausea will be recorded
Post-operative vomiting [0, 15, 30, and 45 minutes after the surgery]
Post-operativevomiting will be recorded
Awareness with recall [30 minutes and 1 day after the surgery]
Awareness will be assessed using the structured interview

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Utah

ClinicalTrials.gov Identifier:

NCT04987580

Other Study ID Numbers:

Single Syringe TIVA

First Posted:

Aug 3, 2021

Last Update Posted:

Aug 3, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 3, 2021