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

Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients :Randomized Control Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03899116
Enrollment
81
Registered
2019-04-02
Start date
2019-08-01
Completion date
2020-01-31
Last updated
2019-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourniquet

Brief summary

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

Detailed 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.

Interventions

gradual deflation with variable degrees

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No

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) ).

Design outcomes

Primary

MeasureTime frameDescription
mean arterial blood pressure15 minutes after start of deflation of cuffThe lowest mean arterial blood pressure during a 15-minute period after starting deflation of the tourniquet.

Secondary

MeasureTime frameDescription
hypotension15 minutes after start of deflation of cuffincidence of post tourniquet hypotension
cardiac output15 minutes after start of deflation of cuffcardiac output after starting deflation using non invasive electrical cardiometry

Countries

Egypt

Contacts

Primary Contactyasmin ibrahim
yalnaby@yahoo.com01006719987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026