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

NCT ID: NCT03408301

Last Updated: 2018-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-29

Study Completion Date

2014-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypotension Blood Pressure, Low

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tourniquet deflation

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

Tourniquet deflation

Intervention Type PROCEDURE

Tourniquet deflation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tourniquet deflation

Tourniquet deflation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Daegu Catholic University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

JongHae Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

JongHae Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CR-13-071

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.