Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03899116
Status:
UNKNOWN
Last Update Posted:
2019-07-25
First Post:
2019-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients :Randomized Control Study
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: