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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Experimental | leg elevation during the beach chair position |
|
| Group C | No Intervention | Patients' leg will be straightened without any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leg elevation | Procedure | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41034767 | Derived | Nam S, Yoo S, Kim SH, Park SK, Lim YJ, Kim JT. Limited effect of leg elevation in preventing intraoperative hypotension during total shoulder arthroplasty in the beach chair position: a randomized controlled trial. BMC Anesthesiol. 2025 Oct 1;25(1):472. doi: 10.1186/s12871-025-03299-1. |
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IPD will be made available after article publication, for 3 years from the study completion.
Proposals should be directed to the corresponding author and will be reviewed by the study group. Only requests that have a methodologically sound proposal and whose proposed use of the data has been approved by the independent review committee will be considered.
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| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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randomized controlled trial
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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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |