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

Cerebral Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393559
• Other study ID #: H-1712-023-903
• Status: Completed
• Phase: N/A
• Start date: January 24, 2018
• Est. completion date: December 21, 2019

Study information

• Verified date: December 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 21, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Hypotension
• Intraoperative Hypotension
• Ischemia
• Shoulder Disease

Intervention

Procedure:
• leg 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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