Skip to main content
OpenTrials
Completed

NCT Number: NCT03408301

The Status of Autonomic Tone Before Tourniquet Deflation During Total Knee Replacement

This study evaluates the influences of the status of sympathovagal balance before tourniquet deflation on a decrease in arterial blood pressure following the deflation during total knee replacement arthroplasty

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypotension Blood Pressure, Low Cardiovascular Diseases Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Daegu Catholic University Medical Center

Daegu, 705-718, South Korea

About this study

Patients present with different hemodynamic profiles after intraoperative tourniquet deflation during total knee replacement arthroplasty.

Sympathovagal balance can be measured before tourniquet deflation and might determine the hemodynamic response to tourniquet deflation.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists physical status I - II
  • Body mass index < 35 kg/m2

Exclusion criteria

  • Coagulation deficiencies
  • Known allergies to local anesthetics
  • Neurologic deficit on the side being operated on
  • Inflammation at the lumbar puncture site
  • Cardiac conduction disorders or arrhythmias
  • Congestive heart failure
  • Serum electrolyte abnormalities
  • Psychiatric disorders
  • Patient's refusal
  • Difficulty communicating with medical personnel
  • Severe hypovolemia
  • Increased intracranial pressure
  • Severe aortic stenosis
  • Severe mitral stenosis

Treatment and study plan

Tourniquet deflation

Procedure

Tourniquet deflation

Primary outcomes

  1. Sympathovagal balance

    Time frame: During 5 minutes before tourniquet deflation

    The ratio of low-to-high frequency power of heart rate variability calculated from the 5-minute long electrocardiogram waveform

Secondary outcomes

  1. Noninvasive hemodynamic parameters

    Time frame: During 5 minutes before tourniquet deflation

    Average cardiac index

  2. Maximum percent change in mean arterial blood pressure

    Time frame: During 10 minutes after tourniquet deflation

    The discrepancy between minimum mean arterial blood pressure after tourniquet deflation and mean arterial blood pressure immediately before tourniquet deflation, which is divided by mean arterial pressure immediately before tourniquet deflation

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

The Effects of Sympathovagal Balance Before Tourniquet Deflation on a Decrease in Arterial Blood Pressure Following the Deflation During Total Knee Replacement Arthroplasty

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2018
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.