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

NCT ID: NCT03899116

Last Updated: 2019-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Tourniquet

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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G50

The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation.

deflation of pneumatic tourniquet

Intervention Type OTHER

gradual deflation with variable degrees

G100

The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation.

deflation of pneumatic tourniquet

Intervention Type OTHER

gradual deflation with variable degrees

G0

The tourniquet cuff will be released till complete deflation.

deflation of pneumatic tourniquet

Intervention Type OTHER

gradual deflation with variable degrees

Interventions

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deflation of pneumatic tourniquet

gradual deflation with variable degrees

Intervention Type OTHER

Eligibility Criteria

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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) ).
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Hassab elnaby

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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yasmin ibrahim

Role: CONTACT

01006719987

Facility Contacts

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yasmin ibrahim

Role: primary

1006719987

Other Identifiers

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101-2018

Identifier Type: -

Identifier Source: org_study_id

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