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

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: Post Induction Hypotension
• Intervention / Treatment: Procedure: Group 1: LEE

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• 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

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: hypotension
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• 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