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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03393559
Other study ID # H-1712-023-903
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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