Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty

Seoul National University

Status: Unknown

Conditions: Osteoarthritis

Treatments: Procedure: Conventional tourniquet pressure; Procedure: Low tourniquet pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT01993758

B-1310/221-007

Details and patient eligibility

About

This study aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet inflation.

Full description

We will compare the two groups of patients undergoing total knee arthroplasty, which the tourniquet pressure will be set differently: systolic blood pressure plus 120mmHg vs. systolic blood pressure plus 150mmHg, the conventional method, in terms of efficacy and safety.

Enrollment: 160 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients undergoing total knee arthroplasty

Exclusion criteria

• Systolic blood pressure measured at ward > 200mmHg
• Thigh circumference > 78cm
• Anesthesia other than spinal anesthesia
• Simultaneous bilateral total knee arthroplasty
• The patients who disagreed the enrollment of this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Conventional tourniquet pressure

Active Comparator group

Description:

The patients in this group will undertake total knee arthroplasty under conventional tourniquet pressure, which will be set as the pressure added by 150mmHg on the last systolic blood pressure just before tourniquet inflation.

Treatment:

Procedure: Conventional tourniquet pressure

Low tourniquet pressure

Experimental group

Description:

The patients in this group will undertake total knee arthroplasty under low tourniquet pressure, which will be set as the pressure added by 120mmHg on the last systolic blood pressure just before tourniquet inflation.

Treatment:

Procedure: Low tourniquet pressure