We sought to study the association between sedation status, medications (benzodiazepines, opioids, and antipsychotics), and clinical outcomes in a resource-limited setting.
A longitudinal study of ...critically ill participants on mechanical ventilation.
Five intensive care units (ICUs) in four public hospitals in Lima, Peru.
One thousand six hundred fifty-seven critically ill participants were assessed daily for sedation status during 28 days and vital status by day 90.
After excluding data of participants without a Richmond Agitation Sedation Scale score and without sedation, we followed 1338 (81%) participants longitudinally for 18,645 ICU days. Deep sedation was present in 98% of participants at some point of the study and in 12,942 ICU days. Deep sedation was associated with higher mortality (interquartile odds ratio (OR) = 5.42, 4.23-6.95; p < 0.001) and a significant decrease in ventilator (- 7.27; p < 0.001), ICU (- 4.38; p < 0.001), and hospital (- 7.00; p < 0.001) free days. Agitation was also associated with higher mortality (OR = 39.9, 6.53-243, p < 0.001). The most commonly used sedatives were opioids and benzodiazepines (9259 and 8453 patient days respectively), and the latter were associated with a 41% higher mortality in participants with a higher cumulative dose (75th vs 25th percentile, interquartile OR = 1.41, 1.12-1.77; p < 0.01). The overall cumulative dose of benzodiazepines and opioids was high, 774.5 mg and 16.8 g, respectively, by day 7 and by day 28; these doses approximately doubled. Haloperidol was only used in 3% of ICU days; however, the use of it was associated with a 70% lower mortality (interquartile OR = 0.3, 0.22-0.44, p < 0.001).
Deep sedation, agitation, and cumulative dose of benzodiazepines were all independently associated with higher 90-day mortality. Additionally, deep sedation was associated with less ventilator-, ICU-, and hospital-free days. In contrast, haloperidol was associated with lower mortality in our study.
The use of continuous sedation until death (CSD) has been highly debated for many years. It is unknown how the use of CSD evolves over time. Reports suggest that there is an international increase in ...the use of CSD for terminally ill patients.
To gain insight in developments in the use of CSD in various countries and subpopulations.
We performed a search of the literature published between January 2000 and April 2020, in PubMed, Embase, CINAHL, PsycInfo, and the Cochrane Library by using the Preferred reporting items for systematic review and meta-analysis protocols guidelines. The search contained the following terms: continuous sedation, terminal sedation, palliative sedation, deep sedation, end-of-life sedation, sedation practice, and sedation until death.
We found 23 articles on 16 nationwide studies and 38 articles on 37 subpopulation studies. In nationwide studies on frequencies of CSD in deceased persons varied from 3% in Denmark in 2001 to 18% in The Netherlands in 2015. Nationwide studies indicate an increase in the use of CSD. Frequencies of CSD in the different subpopulations varied too widely to observe time trends. Over the years, more studies reported on the use of CSD for nonphysical symptoms including fear, anxiety, and psycho-existential distress. In some studies, there was an increase in requests for sedation of patients from their families.
The frequency of CSD seems to increase over time, possibly partly because of an extension of indications for sedation, from mainly physical symptoms to also nonphysical symptoms.
The first computer-assisted personalized sedation (CAPS) device was developed to address the growing demand for routine endoscopy procedures in the United States in the early 2000s. This review will ...describe the environment that gave rise to CAPS and summarize the design of that first device. It will then discuss the market forces that led to the fall of CAPS, with sales of the device ending 2 years after commercialization.
CAPS was initially conceived as a means to enable proceduralists to administer conscious sedation with propofol safely. In the nearly 20 years since its conception, the expectations of patients and proceduralists for endoscopy sedation, have evolved from conscious sedation to deep. Due to the increased risk inherent in deep sedation, future CAPS devices should be tools for anesthesiologists, not proceduralists.
Over $2 billion are spent annually for anesthesia services in routine endoscopic procedures for low-risk patients; a spending rate that is not sustainable. CAPS, in an 'anesthesia oversight' model similar to medical supervision, has a future as a cost-efficient means for anesthesia services to provide sedation in endoscopy and other nonoperating room venues. Anesthesiologists should work with medical device companies and payers to develop a CAPS 'anesthesia oversight' model.
Background The SEDASYS System is an investigational computer-assisted personalized sedation system integrating propofol delivery with patient monitoring to enable endoscopist/nurse teams to safely ...administer propofol. Objective To compare the safety and effectiveness of the SEDASYS System to the current standard of care for sedation during routine endoscopic procedures. Design Nonblinded multicenter randomized comparative study. Setting Four ambulatory surgery centers, 3 endoscopy centers, and 1 academic center in the United States. Patients One thousand American Society of Anesthesiologists physical status class I to III adults undergoing routine colonoscopy or EGD. Interventions Sedation with the SEDASYS System (SED) and sedation with each site's current standard of care (CSC; benzodiazepine/opioid combination). Main Outcome Measurements Area under the curve of oxygen desaturation was the primary endpoint. Secondary endpoints included patient satisfaction, clinician satisfaction, level of sedation, and patient recovery time. Results Four hundred ninety-six patients were randomized to SED and 504 to CSC. Area under the curve of oxygen desaturation was significantly lower for SED (23.6 s·%) than for CSC (88.0 s·%; P = .028). Patients were predominately minimally to moderately sedated in both groups. SED patients were significantly more satisfied than CSC patients ( P = .007). Clinician satisfaction was greater with SED than with CSC ( P < .001). SED patients recovered faster than CSC patients ( P < .001). The incidence of adverse events was 5.8% in the SED group and 8.7% in the CSC group. Limitations Nonblinded. Conclusions The SEDASYS System could provide endoscopist/nurse teams a safe and effective on-label means to administer propofol to effect minimal to moderate sedation during routine colonoscopy and EGD. ( ClinicalTrials.gov identifier: NCT00452426 .)
The safe sedation of children for procedures requires a systematic approach that includes the following: no administration of sedating medication without the safety net of medical/dental supervision, ...careful presedation evaluation for underlying medical or surgical conditions that would place the child at increased risk from sedating medications, appropriate fasting for elective procedures and a balance between the depth of sedation and risk for those who are unable to fast because of the urgent nature of the procedure, a focused airway examination for large (kissing) tonsils or anatomic airway abnormalities that might increase the potential for airway obstruction, a clear understanding of the medication's pharmacokinetic and pharmacodynamic effects and drug interactions, appropriate training and skills in airway management to allow rescue of the patient, age- and size-appropriate equipment for airway management and venous access, appropriate medications and reversal agents, sufficient numbers of staff to both carry out the procedure and monitor the patient, appropriate physiologic monitoring during and after the procedure, a properly equipped and staffed recovery area, recovery to the presedation level of consciousness before discharge from medical/dental supervision, and appropriate discharge instructions. This report was developed through a collaborative effort of the American Academy of Pediatrics and the American Academy of Pediatric Dentistry to offer pediatric providers updated information and guidance in delivering safe sedation to children.
Previous studies have identified an increasing number of gastroenterology (GI) procedures using anesthesia services to provide sedation, with a majority of these services delivered to low-risk ...patients. The aim of this study was to update these trends with the most recent years of data.
We used Medicare and commercial claims data from 2010 to 2013 to identify GI procedures and anesthesia services based on CPT codes, which were linked together using patient identifiers and dates of service. We defined low-risk patients as those who were classified as ASA (American Society of Anesthesiologists) physical status class I or II. For those patients without an ASA class listed on the claim, we used a prediction algorithm to impute an ASA physical status.
Over 6.6 million patients in our sample had a GI procedure between 2010 and 2013. GI procedures involving anesthesia service accounted for 33.7% in 2010 and 47.6% in 2013 in Medicare patients, and 38.3% in 2010 and 53.0% in 2013 in commercially insured patients. Overall, as more patients used anesthesia services, total anesthesia service use in low-risk patients increased 14%, from 27,191 to 33,181 per million Medicare enrollees. Similarly, we observed a nearly identical uptick in commercially insured patients from 15,871 to 22,247 per million, an increase of almost 15%. During 2010-2013, spending associated with anesthesia services in low-risk patients increased from US$3.14 million to US$3.45 million per million Medicare enrollees and from US$7.69 million to US$10.66 million per million commercially insured patients.
During 2010 to 2013, anesthesia service use in GI procedures continued to increase and the proportion of these services rendered for low-risk patients remained high.
Until 2019, guidelines for procedural sedation emphasized a detailed process most applicable for elective procedures scheduled well in advance. These guidelines provided by the American Society of ...Anesthesiologists were adopted by many specialties and institutions, and they have historically served the medical field well. However, cardiologists and other specialists often encounter urgent situations that demand unscheduled sedation. Physicians have been concerned about performing procedures in a fashion that “departs from the guidelines.” In response, the American College of Emergency Physicians (ACEP) has developed a set of guidelines for patients requiring urgent unscheduled sedation. Many of the recommendations made within the novel ACEP guidelines are appropriate for cardiology, but there remain fundamental differences between trauma and other emergencies encountered in the emergency department and urgent cardiac procedures. This paper examines the differences between the American Society of Anesthesiologists and ACEP guidelines and provides some points to consider regarding best practices for cardiologists.
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•Safe, streamlined sedation guidance in urgent or emergent or unscheduled cases are needed.•Traditional guidelines emphasize scheduled procedures; new emergency medicine guidelines are helpful but cover only some cardiology indications.•Our councils make suggestions for developing sound practices for cardiology-oriented urgent procedural sedation.
Background
Although gastrointestinal endoscopy with sedation is increasingly performed in older patients, the optimal level of sedation remains open to debate. In this study, our objective was to ...compare the effects of moderate sedation (MS) and deep sedation (DS) on recovery following outpatient gastroscopy in elderly patients.
Methods
In this randomized, partially blinded, controlled trial, we randomly divided 270 patients older than 60 years who were scheduled for elective outpatient gastroscopy into the MS or DS group based on the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale. The primary outcome was the duration of stay in the post-anesthesia care unit (PACU). Secondary outcomes included the duration of the total hospital stay, frequency of retching, bucking, and body movements during the examination, endoscopist and patient satisfaction, and sedation-associated adverse events during the procedure.
Results
A total of 264 patients completed the study, of whom 131 received MS and 133 received DS. MS was associated with a shorter PACU stay 16.15 ± 9.01 min vs. 20.02 ± 11.13 min,
P
< 0.01 and total hospital stay 27.32 ± 9.86 min vs. 30.82 ± 12.37 min,
P
< 0.05, lesser hypoxemia 2.3% (3/131) vs. 12.8% (17/133),
P
< 0.01, use of fewer vasoactive drugs (
P
< 0.001), and more retching (
P
< 0.001). There was no difference in the incidence of bucking and body movements or endoscopist and patient satisfaction between the two groups.
Conclusion
Compared to deep sedation, moderate sedation may be a preferable choice for American Society of Anesthesiologists (ASA) Grade I–III elderly patients undergoing outpatient gastroscopies, as demonstrated by shorter PACU stays and total hospital stays, lower sedation-associated adverse events, and similar levels of endoscopist and patient satisfaction.
Summary
The multidisciplinary International Committee for the Advancement of Procedural Sedation presents the first fasting and aspiration prevention recommendations specific to procedural sedation, ...based on an extensive review of the literature. These were developed using Delphi methodology and assessment of the robustness of the available evidence. The literature evidence is clear that fasting, as currently practiced, often substantially exceeds recommended time thresholds and has known adverse consequences, for example, irritability, dehydration and hypoglycaemia. Fasting does not guarantee an empty stomach, and there is no observed association between aspiration and compliance with common fasting guidelines. The probability of clinically important aspiration during procedural sedation is negligible. In the post‐1984 literature there are no published reports of aspiration‐associated mortality in children, no reports of death in healthy adults (ASA physical status 1 or 2) and just nine reported deaths in adults of ASA physical status 3 or above. Current concerns about aspiration are out of proportion to the actual risk. Given the lower observed frequency of aspiration and mortality than during general anaesthesia, and the theoretical basis for assuming a lesser risk, fasting strategies in procedural sedation can reasonably be less restrictive. We present a consensus‐derived algorithm in which each patient is first risk‐stratified during their pre‐sedation assessment, using evidence‐based factors relating to patient characteristics, comorbidities, the nature of the procedure and the nature of the anticipated sedation technique. Graded fasting precautions for liquids and solids are then recommended for elective procedures based upon this categorisation of negligible, mild or moderate aspiration risk. This consensus statement can serve as a resource to practitioners and policymakers who perform and oversee procedural sedation in patients of all ages, worldwide.
Background and Aim
Since 2008, there exists a German S3‐guideline allowing non‐anesthesiological administration of propofol for gastrointestinal endoscopy. In this prospective, national, multicenter ...study, we evaluated the safety of endoscopist‐administered propofol sedation (EDP) in German outpatient practices of Gastroenterology.
Methods
In this multicenter survey of 53 ambulatory practices of Gastroenterology, we prospectively evaluated 24 441 patients that had received EDP. We recorded adverse events during the endoscopic procedure and additionally retrieved questionnaires investigating subjective parameters 24 h after the endoscopic procedure.
Results
In 24 441 patients 13 793 colonoscopies, 6467 esophagogastroduodenoscopies, and 4181 double examinations were performed. In this study, 52.1% of the patients received propofol mono‐sedation, and 47.9% received a combination of midazolam and propofol. Major adverse events occurred in four patients (0.016%) enrolled to this study (three mask ventilations and one laryngospasm). Minor adverse events were observed in 112 patients (0.46%) with hypoxemia being the most common minor event. All patients with adverse events recovered without persistent impairment. Minor adverse events occurred more frequently in patients sedated with propofol mono compared to propofol and midazolam (P < 0.0001) and correlated with increasing propofol dosages (P < 0.001; Pearson correlation coefficient r = 0.044). Twenty‐four hours after the endoscopy, patients sedated with propofol plus midazolam stated a significantly reduced sensation of pain (P < 0.01) and improved symptoms of dizziness, nausea and vomiting (P < 0.001) compared to patients having received propofol mono‐sedation.
Conclusion
Four years after the implementation of a German S3‐Guideline for endoscopic sedation, we demonstrated that EDP is a safe procedure.
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