NCT03408301

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2014

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2014

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

January 17, 2018

Last Update Submit

January 17, 2018

Conditions

HypotensionBlood Pressure, Low

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Noninvasive hemodynamic parameters

    During 5 minutes before tourniquet deflation

  • Maximum percent change in mean arterial blood pressure

    During 10 minutes after tourniquet deflation

Study Arms (1)

Tourniquet deflation

Tourniquet deflation after insertion of the prosthetic components during total knee replacement arthroplasty under spinal anesthesia

Procedure: Tourniquet deflation

Interventions

Tourniquet deflationPROCEDURE

Tourniquet deflation

Tourniquet deflation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing total knee replacement arthroplasty in a tertiary university hospital

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 705-718, South Korea

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • JongHae Kim, M.D.

    Daegu Catholic University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 24, 2018

Study Start

January 29, 2014

Primary Completion

July 29, 2014

Study Completion

July 30, 2014

Last Updated

January 24, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)