Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty

Completed

• Conditions: Primary Total Hip Arthroplasty; Hypotension; Database; Total Hip Arthroplasty
• Interventions: Other: Chart Review

• Registration Number: NCT03973320
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Study Timeline

• Study Start: 2018-12-27
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-04
• Primary Completion: 2019-11-18
• Study Completion: 2019-11-18
• Results First Submitted: 2022-05-05
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-28
• Results First Posted: 2024-04-05
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11292

Inclusion Criteria

• All primary total hip arthroplasty patient data with sufficiently complete intraoperative vital signs

Exclusion Criteria

• Revision primary total hip arthroplasty
• Incomplete intraoperative vital signs
• Anterior total hip arthroplasty

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Total Hip Arthroplasty	Chart Review	This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality	Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery	The association between levels and length of intraoperative controlled hypotension and incidence rates of individual and composite outcome of any of the following events: (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death. If any of these events are positive, then the composite outcome will be positive. The units of measurement will be the same.

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States