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

February 22, 2026 updated by: Ranganathan Govindaraj, The University of Texas Health Science Center, Houston

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: LEE
Procedure: Group 1: LEE
Patients will be in supine position during induction with a 12" wedge placed at the level of the Achilles tendon (LEE)
No Intervention: Group 2: no LEE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Change in heart rate
Time Frame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Number of participants that need rescue vasoactive agents
Time Frame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Accumulated dose of rescue vasoactive agents
Time Frame: End of study (within 15 minutes of baseline)
End of study (within 15 minutes of baseline)
Change in non-invasive cardiac output
Time Frame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Ranganathan Govindaraj, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2024

Primary Completion (Actual)

June 27, 2025

Study Completion (Actual)

June 27, 2025

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-22-0145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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