Intraoperative Hypotension, Cerebral Ischemia, Shoulder Disease
Conditions
Brief summary
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.
Interventions
PROCEDUREleg elevation
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative hypotension | From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours) | Mean blood pressure \< 60 mmHg or systolic blood pressure \< 80% of baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total amounts of administered inotropic agents | From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours) | Total amounts of administered inotropic agents after the Beach-chair positioning |
| Systolic blood pressure | before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning | Systolic blood pressure in mmHg at multiple time-points |
| Incidence of intraoperative cerebral desaturation | From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours) | Cerebral oxygen saturation \< 80% of baseline longer than 30 seconds |
| Peripheral oxygen saturation | before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning | Peripheral oxygen saturation in percentage at multiple time-points |
| Cerebral oxygen saturation | before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning | Cerebral oxygen saturation in percentage at multiple time-points |
| Heart rate | before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning | Heart rate in bpm at multiple time-points |
Countries
South Korea
Outcome results
None listed