Post Induction HypotensionNCT06513169
Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia
A study testing Group 1: LEE in people with Post Induction Hypotension, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Induction Hypotension
- What is being tested?
- Group 1: LEE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA)3 or lower
- Patients requiring general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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
- Conditions
- Post Induction Hypotension
- Being tested
- Group 1: LEE
- Keywords
- hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: LEEProcedure or surgery
Patients will be in supine position during induction with a 12" wedge placed at the level of the Achilles tendon (LEE)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: LEE | Experimental | Not described Receives: Procedure: Group 1: LEE |
| Group 2: no LEE | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Secondary outcomes (5)
Number of participants that demonstrate Nadir blood pressure
Nadir blood pressure is the lowest value of blood pressure (BP) that can occur
Measured: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Change in heart rate
Measured: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Number of participants that need rescue vasoactive agents
Measured: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Accumulated dose of rescue vasoactive agents
Measured: End of study (within 15 minutes of baseline)
Change in non-invasive cardiac output
Measured: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start12 Aug 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Induction HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ranganathan Govindaraj, The University of Texas Health Science Center, Houston
- Investigators
- Ranganathan Govindaraj, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513169
- Sponsor's protocol ID
- HSC-MS-22-0145
- Status last verified
- Feb 2026
- First submitted
- 9 Jul 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia - a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06513169
- Acronym / sponsor ID
- HSC-MS-22-0145
- Conditions
- Post Induction Hypotension
- Keywords
- hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: LEE | Experimental | Procedure: Group 1: LEE |
| Group 2: no LEE | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA)3 or lower
- Patients requiring general anesthesia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1: LEEPatients will be in supine position during induction with a 12" wedge placed at the level of the Achilles tendon (LEE) | Procedure or surgery | Group 1: LEE |
Primary outcome
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
5 secondary outcomes
Number of participants that demonstrate Nadir blood pressure
Time frame: 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)
Number of participants that need rescue vasoactive agents
Time frame: 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)
Change in non-invasive cardiac output
Time frame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Post Induction Hypotension
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ED50/ED90 of Phenylephrine Infusion for Preventing Spinal Anesthesia-Induced Hypotension: Supine vs Left-Tilt 15°
Hypotension After Spinal Anesthesia
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Frequency of Electrical Acupoint Stimulation on Hypotension During Induction
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Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery
Intraoperative Hypotension, Jugular Veins
Not yet recruitingObservational study
SV and IVC Collapsibility Index to Predict Postinduction Hypotension
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranganathan Govindaraj, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: LEE in people with Post Induction Hypotension, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that demonstrate hypotension (time frame: From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.