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

Not Applicable

Completed

• Conditions: Shoulder Disease; Intraoperative Hypotension; Cerebral Ischemia
• Interventions: Procedure: leg elevation

• Registration Number: NCT03393559
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-08
• Study Start: 2018-01-24
• Status Verified: 2019-12
• Primary Completion: 2019-12-11
• Study Completion: 2019-12-21
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	leg elevation	leg elevation during the beach chair position

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of