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Evaluating The Cardiovascular Effects of Tourniquet Application

M

Merve Şeker

Status

Completed

Conditions

Orthopedic Disorder
Hemodynamic Instability

Treatments

Device: Mostcare (Vytech, Vygon, Padua, Italy)

Study type

Observational

Funder types

Other

Identifiers

NCT06158165
AcibademStudy

Details and patient eligibility

About

The goal of this prospective observational study is to investigate the impact of tourniquet application on cardiac efficiency through the cardiac cycle efficiency parameter and to explore how central regional technique alters this effect compared to general anesthesia.

We aim to answer the following main questions: 1) Does the use of a tourniquet reduce cardiac efficiency? 2) Does the impact of tourniquet use on cardiac efficiency vary with general anesthesia or central regional technique? The patients included in the study will be divided into two groups based on whether they receive general anesthesia or combined spinal epidural anesthesia.The patients' cardiac cycle efficiency and advanced hemodynamic monitoring parameters will be recorded during procedure.

Full description

After obtaining ethical committee approval (ATADEK; 2022-14/12), 43 patients undergoing elective unilateral total knee arthroplasty under tourniquet were enrolled in our prospective observational study. Patients were divided into two groups: general anesthesia (Group GA: 22 patients) or combined spinal epidural anesthesia (Group CSEA: 21 patients). Cardiac and vascular parameters were recorded using the new algorithmic application of arterial wave analysis called Pressure Recording Analytical Method (PRAM) at 9 time points: (T1) pre-anesthesia, (T2) post-anesthesia before tourniquet inflation, (T3-8) during tourniquet inflation, and (T9) after tourniquet deflation.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Planned for Elective Unilateral Total Knee Arthroplasty Under Tourniquet Application
  • Aged 18 and over
  • Either general anesthesia (GA) or combined spinal-epidural anesthesia (CSEA) will be administered

Exclusion criteria

  • Patients under 18 years of age
  • Patients with heart failure
  • Patients with valve disease
  • Patients with rhythm disorders
  • Patients with a history of myocardial infarction in the last 3 months
  • Patients unwilling to provide consent

Trial design

43 participants in 2 patient groups

General Anesthesia
Description:
Patients undergoing elective unilateral total knee arthroplasty with tourniquet application under the general anesthesia technique
Treatment:
Device: Mostcare (Vytech, Vygon, Padua, Italy)
Combined Spinal Epidural Anesthesia
Description:
Patients undergoing elective unilateral total knee arthroplasty with tourniquet application under the combined spinal epidural anesthesia technique
Treatment:
Device: Mostcare (Vytech, Vygon, Padua, Italy)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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