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

NCT03393559 | Completed

• 1 other identifier: H-1712-023-903
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Hypotension; Cerebral Ischemia; Shoulder Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of intraoperative cerebral desaturation

  From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)

• Total amounts of administered inotropic agents

  From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)

• Systolic blood pressure

  before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning

• Heart rate

  before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes 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

Study Arms (2)

Group L

EXPERIMENTAL

leg elevation during the beach chair position

Procedure: leg elevation

Group C

NO INTERVENTION

Patients' leg will be straightened without any intervention.

Interventions

leg elevation 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 L

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients undergoing shoulder surgery in the beach chair position

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Nam S, Yoo S, Kim SH, Park SK, Lim YJ, Kim JT. Limited effect of leg elevation in preventing intraoperative hypotension during total shoulder arthroplasty in the beach chair position: a randomized controlled trial. BMC Anesthesiol. 2025 Oct 1;25(1):472. doi: 10.1186/s12871-025-03299-1.

  PMID: 41034767 DERIVED

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jin-Tae Kim, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 8, 2018
• Study Start: January 24, 2018
• Primary Completion: December 11, 2019
• Study Completion: December 21, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available after article publication, for 3 years from the study completion.
• Access Criteria: Proposals should be directed to the corresponding author and will be reviewed by the study group. Only requests that have a methodologically sound proposal and whose proposed use of the data has been approved by the independent review committee will be considered.

Locations

KR (1)