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OpenTrials
Completed

NCT Number: NCT06513169

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

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

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Key information

Conditions

Post Induction Hypotension Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Group 1: LEE

Procedure

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

Primary outcomes

  1. Number of participants that demonstrate hypotension

    Time frame: From 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 outcomes

  1. Number of participants that demonstrate Nadir blood pressure

    Time frame: From 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

  2. Change in heart rate

    Time frame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)

  3. Number of participants that need rescue vasoactive agents

    Time frame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)

  4. Accumulated dose of rescue vasoactive agents

    Time frame: End of study (within 15 minutes of baseline)

  5. Change in non-invasive cardiac output

    Time frame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Feb 24, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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