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NCT Number: NCT03393559

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

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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Key information

Conditions

Intraoperative Hypotension Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Ischemia Cerebrovascular Disorders Nervous System Diseases Shoulder Disease Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of intraoperative hypotension

    Time frame: 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 outcomes

  1. Incidence of intraoperative cerebral desaturation

    Time frame: 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

  2. Total amounts of administered inotropic agents

    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 after the Beach-chair positioning

  3. Systolic blood pressure

    Time frame: 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

  4. Heart rate

    Time frame: 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

  5. Peripheral oxygen saturation

    Time frame: 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

  6. Cerebral oxygen saturation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2018
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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