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NCT03408301 Clinical Trial

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

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03408301
Other study ID # CR-13-071
Secondary ID
Status Completed
Phase N/A
First received January 17, 2018
Last updated January 17, 2018
Start date January 29, 2014
Est. completion date July 30, 2014

Study information
Verified date January 2018
Source Daegu Catholic University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 30, 2014
Est. primary completion date July 29, 2014
Accepts healthy volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Tourniquet deflation
Tourniquet deflation

Locations
Country Name City State
Korea, Republic of Daegu Catholic University Medical Center Daegu

Sponsors (1)
Lead Sponsor Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Noninvasive hemodynamic parameters Average cardiac index During 5 minutes before tourniquet deflation
Secondary 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
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