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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-24

Study Completion Date

2019-12-21

Brief Summary

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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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Detailed Description

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Conditions

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Intraoperative Hypotension Cerebral Ischemia Shoulder Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group L

leg elevation during the beach chair position

Group Type EXPERIMENTAL

leg elevation

Intervention Type 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.

Group C

Patients' leg will be straightened without any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No