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

• Conditions: Tourniquet
• Interventions: Other: deflation of pneumatic tourniquet

• Registration Number: NCT03899116
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-31
• Study First Posted: 2019-04-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-25
• Study Start: 2019-08-01
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 81

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) ).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
mean arterial blood pressure	15 minutes after start of deflation of cuff	The lowest mean arterial blood pressure during a 15-minute period after starting deflation of the tourniquet.

Secondary Outcome Measures

Name	Time	Method
hypotension	15 minutes after start of deflation of cuff	incidence of post tourniquet hypotension
cardiac output	15 minutes after start of deflation of cuff	cardiac output after starting deflation using non invasive electrical cardiometry

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt