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

Seoul National University Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Intraoperative Hypotension Cerebral Ischemia Shoulder Disease

Interventions

leg elevationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Incidence of intraoperative hypotension

Mean blood pressure \< 60 mmHg or systolic blood pressure \< 80% of baseline

Time frame: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)

Secondary Outcomes

Incidence of intraoperative cerebral desaturation

Cerebral oxygen saturation \< 80% of baseline longer than 30 seconds

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.