Clinical trial NCT03393559: Effect of Leg Elevation on Prevention of Intraoperative Hypotension During Beach Chair Position
Official title: The Effect of Leg Elevation on the Prevention of Intraoperative Hypotension During Shoulder Surgery in the Beach Chair Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Hypotension
Cerebral Ischemia
Shoulder Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of intraoperative hypotension
timeFrame: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
Secondary outcomes:
measure: Incidence of intraoperative cerebral desaturation
timeFrame: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
measure: Total amounts of administered inotropic agents
timeFrame: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
measure: Systolic blood pressure
timeFrame: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
measure: Heart rate
timeFrame: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
measure: Peripheral oxygen saturation
timeFrame: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
measure: Cerebral oxygen saturation
timeFrame: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: