Skip to content

Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia

Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia - a Prospective Randomized Controlled Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06513169
Enrollment
200
Registered
2024-07-22
Start date
2024-08-12
Completion date
2025-06-27
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Induction Hypotension

Keywords

hypotension

Brief summary

The purpose of this study is to determine if lower extremity elevation (LEE) will reduce the incidence of postinduction hypotension, to compare the utilization of vasoactive medications after induction in patients with LEE and patients without LEE and to determine if LEE will increase measured cardiac output

Interventions

PROCEDUREGroup 1: LEE

Patients will be in supine position during induction with a 12" wedge placed at the level of the Achilles tendon (LEE)

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA)3 or lower * Patients requiring general anesthesia

Exclusion criteria

* Allergic reaction to drugs commonly used for general anesthesia including fentanyl, midazolam, propofol, ephedrine and phenylephrine * Pregnant women * Requiring rapid sequence induction * Prisoners * Patient refusal * Emergency Surgery

Design outcomes

Primary

MeasureTime frameDescription
Number of participants that demonstrate hypotensionFrom start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)Hypotension is defined as the reduction in mean arterial pressure by 20% or greater comparing the blood pressure measured before induction of anesthesia

Secondary

MeasureTime frameDescription
Number of participants that demonstrate Nadir blood pressureFrom start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)Nadir blood pressure is the lowest value of blood pressure (BP) that can occur
Change in heart rateFrom start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Number of participants that need rescue vasoactive agentsFrom start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Accumulated dose of rescue vasoactive agentsEnd of study (within 15 minutes of baseline)
Change in non-invasive cardiac outputFrom start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRanganathan Govindaraj, MD

The University of Texas Health Science Center, Houston

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026