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Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Tourniquet

Treatments

Other: deflation of pneumatic tourniquet

Study type

Observational

Funder types

Other

Identifiers

NCT03899116
101-2018

Details and patient eligibility

About

Deflation of the pneumatic tourniquet used in lower limb surgery is usually associated with hemodynamic instability, metabolic and respiratory changes. These changes are usually tolerated by young, healthy patients; However, these complications are risky for elderly and cardiac patients. The aim of this study is to assess the effect of gradual deflation of thigh tourniquet on the hemodynamics and arterial blood gases compared to the usual practice

Full description

Pneumatic tourniquet will be applied on the mid- thigh with cuff pressure of 350 mm Hg. After the end of surgery, the lower limb will be elevated at 45-degree and the patients will randomized into one of the three groups:

G 50 (n=30) : The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation.

G 100 (n=30): The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation.

G 0 (n=30): The tourniquet cuff will be released till complete deflation. If hypotension is observed during the procedure, it will be managed by 10 mg ephedrine.

Enrollment

81 estimated patients

Sex

All

Ages

50 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • scheduled for elective orthopedic lower limb surgery under pneumatic tourniquet

Exclusion criteria

  • BMI ≥35Kg/ m2
  • patients with unstable angina, left ventricular dysfunction , cerebrovascular disease ,bleeding disorders
  • contraindication to tourniquet insertion
  • patients requiring massive intraoperative blood transfusion (Blood loss more than 50% of the patients' blood volume (70 ml/Kg) ).

Trial design

81 participants in 3 patient groups

G50
Description:
The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation.
Treatment:
Other: deflation of pneumatic tourniquet
G100
Description:
The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation.
Treatment:
Other: deflation of pneumatic tourniquet
G0
Description:
The tourniquet cuff will be released till complete deflation.
Treatment:
Other: deflation of pneumatic tourniquet

Trial contacts and locations

1

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Central trial contact

yasmin ibrahim

Data sourced from clinicaltrials.gov

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