NCT04987580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

July 22, 2021

Last Update Submit

July 26, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Single Syringe TIVA

    Duration of time that processed EEG values are within acceptable limits during maintenance of anesthesia

    during the surgery

Secondary Outcomes (9)

  • Hemodynamic Instability

    during the surgery

  • Incidence of vasoactive dosage

    during the surgery

  • Intra-operative movement

    during the surgery

  • Time to emergence

    during the surgery

  • Anesthesia provider team

    Immediately following the surgery

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to an orthopedic surgery center for elective surgery.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 3, 2021

Study Start

June 1, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

US(1)