Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia

Study Overview
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Brief Summary
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Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.

Detailed Description
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This is a randomized, prospective study which will include a total of 200 patients who are scheduled to undergo elective surgery. The research participants will be randomly assigned to a control group that will receive a low preemptive volume loading (50 mL of gelatin), a protocol group that will receive a high preemptive volume loading (500 mL of gelatin). Volume loading is preceded by the measurement of stroke volume and cardiac output before and after a passive leg elevation test and followed by a standardized anesthetic protocol.

Official Title
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Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Gelatin 500 mL
* Drug: Gelatin 50 mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing elective surgery. Exclusion Criteria: Difficult peripheral venous access Allergy to gelatin Symptomatic cardiac disease, rhythm trouble, pace-maker, aortic valvular disease, aortic disease Morbid obesity, low BMI, hypovolemia, Raynaud syndrome or scleroderma, Contra-indication to propofol, remifentanil or to the use of Bispectral Index, Hematocrit < 20%.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High pre-emptive volume loading<br> | Drug: Gelatin 500 mL<br>* intravenous administration<br>|
| Active Comparator: Low pre-emptive volume loading<br> | Drug: Gelatin 50 mL<br>* intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | mean arterial pressure less than 70% of the baseline measurement | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic effect of leg passive elevation test |  | 30 minutes | 
| hemodynamic effect of volume loading |  | 30 minutes | 
| heart rate monitoring |  | 30 minutes | 
| propofol dose when bispectral index is 50 |  | 30 minutes | 
| propofol site effect concentration when bispectral index is 50 |  | 30 minutes | 
| arterial pressure monitoring |  | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, anesthesia, induction, hypotension, cardiac output