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

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

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

Study Overview

• Status: Completed
• Conditions: Hypotension; Blood Pressure, Low
• Intervention / Treatment: Procedure: Tourniquet deflation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 705-718
    • Daegu Catholic University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing total knee replacement arthroplasty in a tertiary university hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Coagulation deficiencies
2. Known allergies to local anesthetics
3. Neurologic deficit on the side being operated on
4. Inflammation at the lumbar puncture site
5. Cardiac conduction disorders or arrhythmias
6. Congestive heart failure
7. Serum electrolyte abnormalities
8. Psychiatric disorders
9. Patient's refusal
10. Difficulty communicating with medical personnel
11. Severe hypovolemia
12. Increased intracranial pressure
13. Severe aortic stenosis
14. Severe mitral stenosis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tourniquet deflation; Tourniquet deflation after insertion of the prosthetic components during total knee replacement arthroplasty under spinal anesthesia	Procedure: Tourniquet deflation; Tourniquet deflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sympathovagal balance	The ratio of low-to-high frequency power of heart rate variability calculated from the 5-minute long electrocardiogram waveform	During 5 minutes before tourniquet deflation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noninvasive hemodynamic parameters	Average cardiac index	During 5 minutes before tourniquet deflation
Maximum percent change in mean arterial blood pressure	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	During 10 minutes after tourniquet deflation

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2014
• Primary Completion (ACTUAL): July 29, 2014
• Study Completion (ACTUAL): July 30, 2014

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (ACTUAL): January 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: CR-13-071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No