Abstract:
BACKGROUND:While US Food and Drug Administration (FDA) black box warnings are common, their impact on perioperative outcomes is unclear. Hydroxyethyl starch (HES) is associated with increased bleeding and kidney injury in patients with sepsis, leading to an FDA black box warning in 2013. Among patients undergoing musculoskeletal surgery in a subset of hospitals where colloid use changed from HES to albumin following the FDA warning, we examined the rate of major perioperative bleeding post- versus pre-FDA warning. METHODS:The authors of this article used a retrospective, quasi-experimental, repeated cross-sectional, interrupted time series study of patients undergoing musculoskeletal surgery in hospitals within the Premier Healthcare Database, in the year before and year after the 2013 FDA black box warning. We examined patients in 23 "switcher" hospitals (where the percentage of colloid recipients receiving HES exceeded 50% before the FDA warning and decreased by at least 25% in absolute terms after the FDA warning) and patients in 279 "nonswitcher" hospitals. Among patients having surgery in "switcher" and "nonswitcher" hospitals, we determined monthly rates of major perioperative bleeding during the 12 months after the FDA warning, compared to 12 months before the FDA warning. Among patients who received surgery in "switcher" hospitals, we conducted a propensity-weighted segmented regression analysis assessing differences-in-differences (DID), using patients in "nonswitcher" hospitals as a control group. RESULTS:Among 3078 patients treated at "switcher" hospitals (1892 patients treated pre-FDA warning versus 1186 patients treated post-FDA warning), demographic and clinical characteristics were well-balanced. Two hundred fifty-one (13.3%) received albumin pre-FDA warning, and 900 (75.9%) received albumin post-FDA warning. Among patients undergoing surgery in "switcher" hospitals during the pre-FDA warning period, 282 of 1892 (14.9%) experienced major bleeding during the hospitalization, compared to 149 of 1186 (12.6%) following the warning. In segmented regression, the adjusted ratio of slopes for major perioperative bleeding post- versus pre-FDA warning was 0.98 (95% confidence interval [CI], 0.93-1.04). In the DID estimate using "nonswitcher" hospitals as a control group, the ratio of ratios was 0.93 (95% CI, 0.46-1.86), indicating no significant difference. CONCLUSIONS:We identified a subset of hospitals where colloid use for musculoskeletal surgery changed following a 2013 FDA black box warning regarding HES use in sepsis. Among patients undergoing musculoskeletal surgery at these "switcher" hospitals, there was no significant decrease in the rate of major perioperative bleeding following the warning, possibly due to incomplete practice change. Evaluation of the impact of systemic changes in health care may contribute to the understanding of patient outcomes in perioperative medicine.
journal_name
Anesth Analgjournal_title
Anesthesia and analgesiaauthors
Krishnamoorthy V,Ellis AR,McLean DJ,Stefan MS,Nathanson BH,Cobert J,Lindenauer PK,Brookhart MA,Ohnuma T,Raghunathan Kdoi
10.1213/ANE.0000000000004942subject
Has Abstractpub_date
2020-10-01 00:00:00pages
1193-1200issue
4eissn
0003-2999issn
1526-7598pii
00000539-202010000-00028journal_volume
131pub_type
杂志文章abstract::Lung dysfunction after cardiopulmonary bypass and lung transplantation results from oxidant-mediated cellular damage. Previously, we observed the shedding of angiotensin-converting enzyme (ACE) from the endothelial cell surface to be a more sensitive and earlier marker of oxidative lung endothelial injury than lung we...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/01.ANE.0000147707.49192.88
更新日期:2005-04-01 00:00:00
abstract:UNLABELLED:Patients receiving effective thoracic epidural analgesia for postthoracotomy pain may still complain of severe ipsilateral shoulder pain. The etiology of this pain is unclear. In this randomized, double-blinded, placebo-controlled study, we investigated the effect of phrenic nerve infiltration with lidocaine...
journal_title:Anesthesia and analgesia
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1097/00000539-200108000-00004
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journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0000000000002904
更新日期:2018-07-01 00:00:00
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journal_title:Anesthesia and analgesia
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1987-02-01 00:00:00
abstract:UNLABELLED:Although isoflurane can reduce ischemic neuronal injury after short postischemic recovery intervals, this neuroprotective efficacy is not sustained. Neuronal apoptosis can contribute to the gradual increase in infarct size after ischemia. This suggests that isoflurane, although capable of reducing early neur...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/01.ane.0000105872.76747.f6
更新日期:2004-03-01 00:00:00
abstract::After Fontan repair in children, we performed a prospective, open-label study to evaluate the effect of amrinone on pulmonary vascular resistance (PVRI). Eight patients who underwent the Fontan repair had baseline arterial pressure, left atrial pressure, central venous pressure, and cardiac output measured postoperati...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1097/00000539-199602000-00004
更新日期:1996-02-01 00:00:00
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journal_title:Anesthesia and analgesia
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1097/00000539-200209000-00045
更新日期:2002-09-01 00:00:00
abstract:BACKGROUND:It remains unknown whether continuous or scheduled intermittent bolus local anesthetic administration is preferable for transversus abdominis plane (TAP) catheters. We therefore tested the hypothesis that when using TAP catheters, providing local anesthetic in repeated bolus doses increases the cephalad-caud...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,随机对照试验
doi:10.1213/ANE.0000000000001939
更新日期:2017-04-01 00:00:00
abstract::Patients with coronavirus disease 2019 (COVID-19) frequently experience a coagulopathy associated with a high incidence of thrombotic events leading to poor outcomes. Here, biomarkers of coagulation (such as D-dimer, fibrinogen, platelet count), inflammation (such as interleukin-6), and immunity (such as lymphocyte co...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,评审
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abstract::Morphine anesthesia is often recommended in patients with reduced cardiac reserve. As the effect of morphine on the balance between myocardial oxygen supply and demand is not well understood, the effect of large doses of morphine (3 mg/kg, subcutaneously) on experimental myocardial infarction size in the rat was evalu...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:
更新日期:1982-10-01 00:00:00
abstract::The management of postoperative nausea and vomiting (PONV) remains a persistent problem. Despite the use of prophylactic antiemetics, breakthrough nausea and vomiting still frequently occur. There have been no published studies comparing dolasetron and ondansetron for the treatment of PONV. This was a prospective, ran...
journal_title:Anesthesia and analgesia
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1213/01.ANE.0000144421.96275.D1
更新日期:2005-02-01 00:00:00
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journal_title:Anesthesia and analgesia
pub_type: 杂志文章,随机对照试验
doi:10.1213/ane.0b013e3181a04d4c
更新日期:2009-05-01 00:00:00
abstract::A series of groups of Sprague-Dawley rats were given either secobarbital, phenobarbital, morphine, pentazocine, diazepam, methotrimeprazine, or saline (control) intraperitoneally on 4 consecutive days and then, on day 5, anesthetized with chloroform, trichlorethylene, fluroxene, halothane, methoxyflurane, enflurane, i...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/00000539-197501000-00020
更新日期:1975-01-01 00:00:00
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journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0000000000004273
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abstract:BACKGROUND:Vital sign monitors and ventilator/anesthesia workstations are equipped with multiple alarms to improve patient safety. A high number of false alarms can lead to a "crying wolf" phenomenon with consecutively ignored critical situations. Systematic data on alarm patterns and density in the perioperative phase...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0b013e3181fcc504
更新日期:2011-01-01 00:00:00
abstract::The low solubility of desflurane contributes to rapid emergence after outpatient anesthesia. Compared with isoflurane, recovery times to eye opening, response to verbal commands, and orientation to person, place, and time have been significantly shorter. Even when compared with the rapid, short-acting intravenous anes...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,评审
doi:
更新日期:1992-10-01 00:00:00
abstract::The purpose of this study was to evaluate the influence of the volume of methylene blue-local anesthetic on the spread of the injectate along the costal pleura. Twenty patients undergoing elective thoracotomy were studied. Twelve patients received intercostal nerve injection with 10 mL of 0.5% bupivacaine with methyle...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/00000539-199209000-00013
更新日期:1992-09-01 00:00:00
abstract::Clonidine is effective in treating sevoflurane-induced postanesthesia agitation in children. We conducted a study on 169 children to quantify the risk reduction of clonidine agitation in patients admitted to our day-surgery pediatric clinic. Children were randomly allocated to receive clonidine 2 mug/kg or placebo bef...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,随机对照试验
doi:10.1213/01.ANE.0000184204.81877.53
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journal_title:Anesthesia and analgesia
pub_type: 杂志文章
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pub_type: 杂志文章
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journal_title:Anesthesia and analgesia
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2002-08-01 00:00:00
abstract::The average duration of hospitalization after total knee arthroplasty (TKA) in the United States is 4-5 days. In this two-phase study we investigated the feasibility of converting TKA into an overnight-stay procedure using a continuous femoral nerve block provided at home through postoperative day 4. Nine of 10 patien...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/01.ane.0000189562.86969.9f
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:To prevent reflex-induced bronchoconstriction in patients with asthma, local anesthetics are commonly administered by aerosol or IV as adjunct medication. Lidocaine attenuates responsiveness to a neurally active stimulus that increases tone, but there is scant information about the effect of lidocaine on bas...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/01.ane.0000260638.57139.87
更新日期:2007-05-01 00:00:00
abstract:UNLABELLED:We considered elective case scheduling at hospitals and surgical centers at which surgeons and patients choose the day of surgery, cases are not turned away, and anesthesia and nursing staffing are adjusted to maximize the efficiency of use of operating room (OR) time. We investigated scheduling a new case i...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1097/00000539-200204000-00030
更新日期:2002-04-01 00:00:00
abstract::Anesthesia information systems (AIS) record data from patient monitors and create a detailed electronic anesthesia record. Because the anesthesia record is a primary piece of evidence used in court during a malpractice proceeding, the ability to create an anesthesia record has fostered considerable debate concerning t...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/01.ANE.0000130259.52838.3B
更新日期:2004-09-01 00:00:00
abstract:BACKGROUND:The goal of this study was to determine a set of timing, shape, and statistical features available through noninvasive monitoring of maternal electrocardiogram and photoplethysmography that identifies preeclamptic patients. METHODS:Pregnant women admitted to Labor and Delivery were monitored with pulse oxim...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0000000000002532
更新日期:2018-03-01 00:00:00
abstract::Fluid resuscitation is one of the most prevalent treatment in critical care. There is not definitive evidence about the best fluid for resuscitation. The aim of this review will be to asses the efficacy and safety of buffered solution versus saline. We will perform an electronic search in Medline, Embase, and Central....
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,meta分析,评审
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更新日期:2016-12-01 00:00:00
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journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1213/ANE.0000000000002430
更新日期:2018-01-01 00:00:00
abstract:UNLABELLED:The visual analog scale (VAS) has been used to assess the efficacy of pain management regimens in patients with acute postoperative pain, but its usefulness has not been confirmed in postoperative pain studies. We studied 60 subjects in the immediate postoperative period. The specific data collected were: VA...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章
doi:10.1097/00000539-199801000-00020
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND:Vascular access is often technically difficult in children because of the small caliber and impalpability of the veins. In this study, we sought to determine if use of the Vein Entry Indicator Device (VEIDtrade mark) in children facilitates peripheral venous access. METHODS:Two-hundred-two healthy (ASA grad...
journal_title:Anesthesia and analgesia
pub_type: 杂志文章,随机对照试验
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更新日期:2008-11-01 00:00:00