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CompletedNCT06513169Updated Feb 24, 2026

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

An interventional study of Group 1: LEE in Post Induction Hypotension, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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

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Conditions studied

  • Post Induction Hypotension

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Keywords

  • hypotension
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 200 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Group 1: LEE

    Procedure: Group 1: LEE

  • No intervention
    Group 2: no LEE

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)

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What researchers measure

Primary outcomes

  1. Number of participants that demonstrate hypotension

    Hypotension is defined as the reduction in mean arterial pressure by 20% or greater comparing the blood pressure measured before induction of anesthesia

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

Secondary outcomes

  1. Number of participants that demonstrate Nadir blood pressure

    Nadir blood pressure is the lowest value of blood pressure (BP) that can occur

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

  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)

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Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06513169
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Ranganathan Govindaraj (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jul 22, 2024
Start date
Aug 12, 2024
Primary completion
Jun 27, 2025
Completion
Jun 27, 2025
Last update
Feb 24, 2026

Study contacts

Ranganathan Govindaraj, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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