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

Tourniquet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03899116
• Other study ID #: 101-2018
• Status: Not yet recruiting
• Start date: August 1, 2019
• Est. completion date: January 2020

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: yasmin ibrahim
• Phone: 01006719987
• Email: yalnaby[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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) ).

Related Conditions & MeSH terms

• Tourniquet

Intervention

Other:
• deflation of pneumatic tourniquet
gradual deflation with variable degrees

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean arterial blood pressure	The lowest mean arterial blood pressure during a 15-minute period after starting deflation of the tourniquet.	15 minutes after start of deflation of cuff
Secondary	hypotension	incidence of post tourniquet hypotension	15 minutes after start of deflation of cuff
Secondary	cardiac output	cardiac output after starting deflation using non invasive electrical cardiometry	15 minutes after start of deflation of cuff