Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty
Conditions: Total Hip Arthroplasty, Primary Total Hip Arthroplasty, Hypotension, Database
Sponsor: Hospital for Special Surgery, New York

 
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Outcomes after Hypotensive Neuraxial Anesthesia 
in Total Hip Arthroplasty 
FUNDER: 
Department of Anesthesiology 
PROTOCOL NO.: 
2018-2235 
VERSION & DATE: 
12/5/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol Number: 2018-2235  
Version Date:   
 
 
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TABLE OF CONTENTS 
 
TABLE OF CONTENTS ............................................ 2 
PROTOCOL SYNOPSIS ........................................... 3 
2.0 
INTRODUCTION ............................................. 5 
3.0 
OBJECTIVE(S) OF CLINICAL STUDY .......... 5 
4.0 
STUDY HYPOTHESES .................................. 6 
5.0 
STUDY DESIGN ............................................. 6 
5.1 
Endpoints ....................................................................................................................... 6 
5.1.1 
Primary Endpoint ...................................................................................................... 6 
5.1.2 
Secondary Endpoints ................................................................................................ 6 
5.2 
Study Sites ..................................................................................................................... 6 
6.0 
STUDY POPULATION ................................... 6 
6.1 
Number of Subjects ........................................................................................................ 6 
6.2 
Inclusion Criteria............................................................................................................. 7 
6.3 
Exclusion Criteria ........................................................................................................... 7 
7.0 
PROCEDURES ............................................... 7 
7.1 
Data Collection ............................................................................................................... 7 
8.0 
STATISTICAL ANALYSIS .............................. 8 
9.0 
ADVERSE EVENT ASSESSMENT ................ 8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol Number: 2018-2235  
Version Date:   
 
 
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PROTOCOL SYNOPSIS 
 
Protocol Title: 
Outcomes after Hypotensive Neuraxial Anesthesia in Total Hip 
Arthroplasty 
Protocol Number: 
2018-2235 
Protocol Date: 
 
Sponsor: 
Department of Anesthesiology 
Principal Investigator: 
Jiabin Liu, MD, PhD 
Objective: 
The proposed project will be the largest study on deliberate 
hypotensive neuraxial anesthesia and adverse outcome in THA. 
It will provide essential feedback and guidance to our clinical 
practice, indicating whether we need to modify our intraoperative 
management for better patient outcomes and less adverse 
complications, or conversely may allow us to argue that 
deliberate hypotensive neuraxial anesthesia is not associated 
with adverse events. This will be the first significant database 
study to examine the clinical outcomes of patients undergoing 
THA with a deliberative hypotensive neuraxial anesthetic 
technique.    
Study Design: 
Retrospective study 
Enrollment: 
10,000 
Subject Criteria: 
 
All primary THA patient data with sufficiently complete 
intraoperative vital signs will be included in the study. 
Data Collection: 
Sources: Medical record 
Variables: 
• 
MRN 
• 
Age 
• 
BMI 
• 
ASA status 
• 
Ethnicity 
• 
Gender/sex 
• 
zip code 
• 
insurance 
• 
type of surgery 
• 
primary anesthetic type 
• 
anesthetic procedures 
• 
anesthesia provider name 
• 
anesthesia provider helpers (CRNA, Resident, Fellow) 
• 
surgeon 
• 
duration of surgery 
• 
duration of anesthesia 

 
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• 
Problem list of comorbidities (OSA, COPD, asthma, HTN, 
HLD, CAD, CHG, arrhythmia, pulmonary hypertension, DM 
(type 1 or 2), coagulopathy, hx of dvt/PE, anxiety, 
depression, bipolar disorder, schizophrenia, IBS) 
• 
Number of allergies 
• 
Pre-op medications: betablockers, asa, anticoagulant, 
NSAID, Opioid, steroids, ACE inhibitor, calcium antagonists 
and diuretics, blood pressure (pre-op and all intra-op), intra-
op medication: TXA IV or topical, ketamine, blood 
transfusion, albumin, IV fluids, epinephrine, ephedrine, 
phenylephrine, bydralazine, labetalol, 
• 
Laboratory results: hemoglobin, BUN, creatinine (pre-op and 
first post-op) 
• 
Post-operative medications for the first 24 hours: IV fluids, 
albumin, blood transfusion, epinephrine, ephedrine, 
phenylephrine, opioids 
• 
Complications: MI, CVA, death, ARF, pneumonia, 
arrhythmia, DVT, PE 
Statistical Analysis: 
• 
Two-step logistic regression modeling to determine odds 
ratios 
• 
Confidence intervals: 95% 
 
 
 

 
Protocol Number: 2018-2235  
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2.0 INTRODUCTION 
There have been long debates in regards to the appropriate blood pressure 
management during joint replacement.  Traditionally at HSS, many anesthesiologists 
routinely manage the blood pressure in the 40-60 mmHg MAP range to minimizing 
perioperative bleeding and optimize surgical outcome. Such deliberate hypotension 
anesthesia does not seem to cause increased risk of major complications in several 
studies, including studies from our institution (Paul et al, Can J Anesth 2007; 
Bombardieri et al, Anesth Analg, 2016; Weinstein et al. RAPM, 2018). 
 
However, concerns still remain due to evidence from other major studies, which 
indicated increased complication risks with intraoperative hypotension (Salmasi et al, 
Anesthesiology, 2017; Sessler et al, Anesthesiology, 2018). Previous studies at HSS 
are mostly limited by the small number of patients, and therefore could not draw more 
convincing conclusion.  With the implementation of EPIC electronic medical record 
system at HSS in 2016, it is feasible to access thousands of patients’ intra-operative 
data nowadays.  Hereby, we propose this project to study whether there is associated 
between deliberate hypotension and increased adverse outcomes among primary THA 
patients.  In addition, we will explore whether controlled hypotension continues to be an 
effective technique for reducing intra-operative blood loss with modern surgical 
techniques and in the setting of widespread use of tranexamic acid. 
3.0 OBJECTIVE(S) OF CLINICAL STUDY 
 
The goal of this study is to determine if hypotensive neuraxial anesthesia is 
associated with worse outcomes in Primary Total Hip Arthroplasty (THA).There is a 
substantial body of literature supporting the safety and utility of the practice of 
deliberate neuraxial hypotension for reduction of blood loss during THA. However, 
substantial controversy remains regarding the safety of deliberate and controlled 
intraoperative hypotension with epinephrine mediated cardiac output augmentation 
as compared to inadvertent and/or uncontrolled intraoperative hypotension. 
Moreover, it is unclear if advances in surgical practice combined with the 
widespread use of TXA have diminished the clinical utility of deliberate hypotension 
as a means of minimizing blood loss. Therefore, this study is looking at the extent 
and duration of hypotension under neuraxial anesthesia in primary THA surgery. 
 
This proposed project will be the largest study on deliberative hypotensive neuraxial 
anesthesia and adverse outcome in total hip arthroplasty.  It will provide essential 
feedback and guidance to our clinical practice, indicating whether we need to modify 
our intra-operative management for better patient outcomes and less adverse 
complications, or conversely may allow us to argue that deliberate hypotensive 
neuraxial anesthesia is not associated with adverse events. 
 
We will be accessing and reviewing EPIC data of patients who have undergone 
Primary Total Hip Arthroplasty at HSS from January 2016- December 3, 2018 

 
Protocol Number: 2018-2235  
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4.0 STUDY HYPOTHESES 
This is retrospective study hypothesize that: 
A. There is no association between level and duration of hypotension with (i) 
myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death in 
primary total hip arthroplasty patients. 
B. With the use of IV tranexamic acid is administered, the use of deliberate 
neuraxial anesthesia induced hypotension does not result in a further clinically 
relevant reduction in calculated blood loss after total hip arthroplasty. 
5.0 STUDY DESIGN 
5.1 
Endpoints 
5.1.1 Primary Endpoint 
The primary outcomes are the incidences of: 
i. 
myocardial infarction (MI) 
ii. 
cerebrovascular accident (CVA) 
iii. 
death 
iv. 
calculated perioperative intraoperative blood loss. 
 
All primary outcomes are events during the inpatients stay. 
 
5.1.2 Secondary Endpoints 
The secondary outcomes are incidences of: 
i. 
acute renal failure (ARF) 
ii. 
Pneumonia 
iii. 
Arrhythmia 
iv. 
deep venous thrombosis (DVT) 
v. 
pulmonary embolism (PE) 
vi. 
blood transfusion 
5.2 
Study Sites 
This study will take place at the main campus of the Hospital for Special Surgery 
(HSS). 
6.0 STUDY POPULATION 
6.1 
Number of Subjects 
10,000 
 

 
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6.2 
Inclusion Criteria 
All primary THA patient data with sufficiently complete intraoperative vital signs will be 
included in the study. 
6.3 
Exclusion Criteria 
Subjects will be excluded from the study if: 
• 
Revision THA 
• 
Incomplete intraoperative vital signs 
• 
Anterior THA 
7.0 PROCEDURES 
The independent variables of interest include extent of intraoperative hypotension (MAP 
<45, 50, 55, 60 mmHg) and duration of hypotension (5 mins interval). Intraoperative 
blood loss will be calculated based on pre-operative and post-operative laboratory 
hemoglobin levels. 
The outcome variables include MI, CVA, death, intraoperative blood loss, ARF, 
pneumonia, arrhythmia, DVT, PE, and number of packed red blood cell (pRBC) 
transfusions. 
7.1 
Data Collection 
The following data will be collected: 
 
Pre-operative/Baseline 
• 
MRN 
• 
Age 
• 
Height 
• 
Weight 
• 
BMI 
• 
ASA classification 
• 
Ethnicity 
• 
Gender 
• 
Baseline status: METS, substance hx, smoking hx, SOB 
• 
Comorbidity: OSA, COPD, asthma, HTN, CAD, CHF, Arrhythmia, pulmonary 
hypertension, seizure, TIA/CVA, renal dx, DM (type I or type II), 
coagulopathy, hx of dvt/PE 
• 
Pre-op medications: beta-block, asa, anti-coagulant, nsaid, steroids 
• 
Blood pressure: pre-op BP, and all intra-op 
 
Intra-Operative  
• 
Blood pressure: pre-op BP and all intra-op 
• 
Intra-op medications: TXA IV or topical, ketamine, blood transfusion, albumin, 
IV fluids, epinephrine, ephedrine, phenylephrine, hydralazine, labetalol 
 
Post-Operative  
• 
Laboratory results: hemoglobin, BUN, creatinine 

 
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• 
Post-operative medications: (first 24 hours) IV fluids, albumin, blood 
transfusion, epinephrine, ephedrine, phenylephrine 
• 
Complications: MI, CVA, death, ARF, pneumonia, arrhythmia, DVT, PE 
8.0 STATISTICAL ANALYSIS 
1. Proposed analysis (e.g., student’s t-test, ANOVA, chi-square, regression, etc.):  
Two-step logistic regression modeling to determine odds ratios 
2. Confidence intervals: 95% 
3. Total sample size required: 10,000  
 
9.0 ADVERSE EVENT ASSESSMENT 
All Adverse Events (AEs) will be reported in the final study report.