Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT03973320
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty
Sponsor:
Hospital for Special Surgery, New York
Organization:
Study Overview
Official Title:
Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
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:
This is a retrospective chart review to determine if neuraxial anesthesia is associated with worse outcomes after Primary Total Hip Arthroplasty.
Detailed Description:
The goal of this study is to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty. The plan to analyze the outcomes is listed below:
Primary outcomes:
Multiple logistic regression will be used to compute the adjusted odds ratios of any postoperative complications (MI, CVA, death) , adjusting for covariates including duration of intraoperative mean arterial pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure.
Sensitivity analyses will also consider the effects of intra-operative hypotension (IOH) defined as mean blood pressure of less than 40, 45, 50, 55, 60, and 65 mm Hg.
Secondary outcomes:
Multiple logistic regression will be to compute the adjusted odds ratios of individual postoperative complications, (such as MI, CVA, stroke) , adjusting for covariates including duration of intraoperative mean blood pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure. Sensitivity analyses will also be conducted to test the effects of extend of IOH on complications.
Primary outcomes:
Multiple logistic regression will be used to compute the adjusted odds ratios of any postoperative complications (MI, CVA, death) , adjusting for covariates including duration of intraoperative mean arterial pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure.
Sensitivity analyses will also consider the effects of intra-operative hypotension (IOH) defined as mean blood pressure of less than 40, 45, 50, 55, 60, and 65 mm Hg.
Secondary outcomes:
Multiple logistic regression will be to compute the adjusted odds ratios of individual postoperative complications, (such as MI, CVA, stroke) , adjusting for covariates including duration of intraoperative mean blood pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure. Sensitivity analyses will also be conducted to test the effects of extend of IOH on complications.
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?:
None
Is an FDA AA801 Violation?: