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

Not Applicable

Recruiting

• Conditions: Post Induction Hypotension

• Registration Number: NCT06513169
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Study Start: 2024-08-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-10
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants that demonstrate hypotension	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 Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States