Effect of Leg Elevation on Prevention of Intraoperative Hypotension During Beach Chair Position

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of leg elevation on the prevention of intraoperative hypotension during shoulder surgery in the Beach-chair position. patients undergoing shoulder surgery in the Beach-chair position will be randomly assigned to Group L (with leg elevation) or Group C (no intervention). The primary outcome is the incidence of intraoperative hypotension (mean blood pressure < 60mmHg or systolic blood pressure < 80% of baseline). Secondary outcomes are the incidence of intraoperative cerebral desaturation (cerebral oxygen saturation < 80% of baseline, longer than 30 seconds), total amounts of administered inotropic agents, and systolic blood pressure, heart rate, and cerebral oxygen saturation at various time points.

Official Title
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The Effect of Leg Elevation on the Prevention of Intraoperative Hypotension During Shoulder Surgery in the Beach Chair Position

Conditions
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Intraoperative Hypotension, Cerebral Ischemia, Shoulder Disease

Intervention / Treatment
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* Procedure: leg elevation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients undergoing shoulder surgery in the beach chair position Exclusion Criteria: Patients with myocardial infarction Patients with pacemaker Patients with cerebrovascular disease patients with arteriovenous fistula at the opposite arm Patients with autonomic nerve disorders Patients with hip or knee joint disorder limiting hip or knee flexion BMI > 30 kg/m2

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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
Interventional Model Description: randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group L<br>leg elevation during the beach chair position | Procedure: leg elevation<br>* Patients' leg will be raised by a pillow under both legs and the hip and knee joints will be flexed 45 degrees to position both knees at the heart level.<br>|
| No Intervention: Group C<br>Patients' leg will be straightened without any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative hypotension | Mean blood pressure < 60 mmHg or systolic blood pressure < 80% of baseline | From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative cerebral desaturation | Cerebral oxygen saturation < 80% of baseline longer than 30 seconds | From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours) | 
| Total amounts of administered inotropic agents | Total amounts of administered inotropic agents after the Beach-chair positioning | From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours) | 
| Systolic blood pressure | Systolic blood pressure in mmHg at multiple time-points | before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning | 
| Heart rate | Heart rate in bpm at multiple time-points | before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning | 
| Peripheral oxygen saturation | Peripheral oxygen saturation in percentage at multiple time-points | before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning | 
| Cerebral oxygen saturation | Cerebral oxygen saturation in percentage at multiple time-points | before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning |