Passive Leg Raising Test to Predict Hypotension During Induction of Anesthesia in Patients Undergoing Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01144546
First received: June 8, 2010
Last updated: June 14, 2010
Last verified: June 2010
  Purpose

Hypotension frequently occurs during anesthesia induction. Preload decrease by anesthetics was often considered as one of main causes for this hypotension. However, the studies on this topic have been lacking. Dynamic preload indices are more suitable than static preload indices to predict the effect of preload changes. And, recently, passive leg raising test showed successful results to predict fluid responsiveness in patient with spontaneous ventilation.

The investigators hypothesized that hypotension after induction of anesthesia is caused by decrease of preload by anesthetics and passive leg raising test could predict this hypotension. In this study, the investigators will try to evaluate whether passive leg raising induced hemodynamic changes could predict hypotension during anesthesia induction.


Condition Intervention Phase
Ischemic Heart Disease
Cardiac Valve Disease
Procedure: passive leg raising (45 degree leg elevation for 1-2 min)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Passive Leg Raising Test to Predict Hypotension During Induction of Anesthesia in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The area under ROC curve to predict hypotension and refractory hypotension [ Time Frame: 30 min around passive leg raising test ] [ Designated as safety issue: No ]
    area under ROC curve of HR, SV, SVV, and CI changes during PLR to predict hypotension and refractory hypotension


Enrollment: 42
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Passive Leg Raising
elevation of both legs to a 45 degrees for about 1-2 minute before anesthesia induction
Procedure: passive leg raising (45 degree leg elevation for 1-2 min)
the patient's trunk was elevated 45 degrees for the first set of measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was lowered to a supine position to measure peak CO (usually within 1-2 min)
Other Name: PLR

Detailed Description:

In this randomized controlled clinical trial, the investigators hypothesized that passive leg raising induced changes in hemodynamic parameters could predict the hypotension during anesthesia induction. To evaluate this, before anesthesia, the investigators will conduct passive leg raising test. At first, the patient's trunk was elevated 45 degrees for the first set of measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was lowered to a supine position to measure peak CO (usually within 1-2 min). Hemodynamic profiles planned to be measured are mean arterial pressure, heart rate, cardiac index, stoke volume and stroke volume variation. After this, the occurrence of hypotension (systolic blood pressure < 90mmHg or mean arterial pressure decrease > 30% of baseline) will be recorded during the time from anesthesia induction to surgical skin incision. Hypotension will be treated by a standardized method. If heart rate (HR) is less than 70 beats/min, 5mg of ephedrine will be administered and if HR is greater than 70 beats/min, 30 mcg of phenylephrine will be administered. This will repeated until hypotension subsided. Refractory hypotension will be defined as continuous hypotension despite the total infused dose of ephedrine > 0.5 mg/kg or phenylephrine > 4 mcg/kg. The ability to predict hypotension and refractory hypotension during anesthesia induction by passive leg raising test will be evaluated by receiver operating characteristic curve analysis.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients undergoing elective cardiac surgery

Exclusion Criteria:

  • arrhythmias
  • documented peripheral artery disease
  • severe pulmonary disease
  • heart failure
  • unstable angina
  • preoperative use of inotropics or mechanical assist device
  • use of angiotensin converting enzyme inhibitors
  • expected intubation difficulty or gastric reflux disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144546

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Yunseok Jeon, M.D Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yunseok Jeon, MD., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01144546     History of Changes
Other Study ID Numbers: H-0809-037-256
Study First Received: June 8, 2010
Last Updated: June 14, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Passive leg raising
FloTrac/Vigileo
Anesthesia hypotension

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Heart Valve Diseases
Hypotension
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014