Clinical and economic impact of the use of dexmedetomidine for sedation in the intensive care unit compared to propofol.

Background Despite the advantages of dexmedetomidine (DEX) over propofol (PRO) including minimal respiratory depression and the potential for preventing and/or treating intensive care unit (ICU) delirium, PRO has been the preferred agent due to its lower cost. However, the acquisition cost of DEX has considerably decreased as a generic version of DEX has recently become available. Objective To evaluate clinical and economic outcomes of DEX-based sedation compared to PRO in the ICU. Setting A retrospective cohort study of 86 ICU patients who received either DEX or PRO for a period ≥ 12 h. Method Patients were matched by age, sex, and Sequential Organ Failure Assessment scores in a 1:1 ratio. Main outcome measure Clinical outcomes included the duration of mechanical ventilation (MV), ICU and hospital length of stay (LOS), and requirements of concomitant sedatives and opioids. Economic outcomes included the ICU and hospital costs as well as the cost of sedatives or combined sedatives and opioids per patient. Results There were no significant differences in ICU and hospital LOS and time on MV in both groups (median ICU LOS 7 [DEX] vs. 9 [PRO] days, p = 0.07; median hospital LOS 12 [DEX] vs. 14 [PRO] days, p = 0.261; median time of MV 144 [DEX] vs. 158 [PRO] hours, p = 0.176). DEX-based sedation compared to PRO was associated with similar ICU and hospital costs (US$ 67,561 vs. 78,429, p = 0.39; US$ 71,923 vs. 71,084, p = 0.1). Conclusion The clinical outcomes and economic impact associated with DEX- and PRO-based sedation were similar.

Medical, Political, and Economic Considerations for the Use of MAC for Endoscopic Sedation: Big Price, Little Justification?

The last few decades of gastrointestinal (GI) endoscopy have seen phenomenal growth. In many aspects, GI endoscopy has led the field of nonsurgical interventional medicine. In many aspects, this growth is facilitated by advancements in sedation-both drugs and techniques. Unfortunately, the topic of GI endoscopy sedation is also mired in many controversies, mainly emanating from the cost of anesthesia providers. While no one debates their role in the majority of advanced endoscopic procedures, the practice of universal propofol sedation in the USA, delivered by anesthesia providers, needs a closer look. In this review, medical, political, and economic considerations of this important topic are discussed in a very frank and honest way. While such ubiquitous propofol use has increased satisfaction of both patients and gastroenterologists, there is little justification. More importantly, going by the evidence, there is even less justification for the mandated anesthesia providers use for such delivery. Unfortunately, the FDA could not be convinced otherwise. The new drug fospropofol met the same fate. Approval of SEDASYS®, the first computer-assisted personalized sedation system, was a step in the right direction, nevertheless an insufficient step that failed to takeoff. As a result, in spite of years of research and efforts of many august societies, the logjam of balancing cost and justification of propofol sedation has continued. We hope that recent approval of remimazolam, a novel benzodiazepine, and potential approval of oliceridine, a novel short-acting opioid, might be able to contain the cost without compromising the quality of sedation.

Cost-effectiveness of anesthesia maintained with sevoflurane or propofol with and without additional monitoring: a prospective, randomized controlled trial.

BACKGROUND: We compared cost-effectiveness of anesthesia maintained with sevoflurane or propofol with and without additional monitoring, in the clinical setting of ear-nose-throat surgery. METHODS: One hundred twenty adult patients were randomized to four groups. In groups SEVO and SEVO+ anesthesia was maintained with sevoflurane, in group SEVO+ with additional bispectral index (BIS) and train-of-four (TOF) monitoring. In groups PROP and PROP+ anesthesia was maintained with propofol, in group PROP+ with additional BIS and TOF monitoring. RESULTS: Total cost of anesthesia per hour was greater in group SEVO+ compared to SEVO [€ 19.95(8.53) vs. 12.15(5.32), p <  0.001], and in group PROP+ compared to PROP (€ 22.11(8.08) vs. 13.23(4.23), p <  0.001]. Time to extubation was shorter in group SEVO+ compared to SEVO [11.1(4.7) vs. 14.5(3.9) min, p = 0.002], and in PROP+ compared to PROP [12.6(5.4) vs. 15.2(4.7) min, p <  0.001]. Postoperatively, arterial blood pressure returned to its initial values sooner in groups SEVO+ and PROP+. CONCLUSIONS: Our study demonstrated that the use of BIS and TOF monitoring decreased the total cost of anesthesia drugs and hastened postoperative recovery. However, in our circumstances, these were associated with higher disposables costs. Detailed cost analysis and further investigations are needed to identify patient populations who would benefit most from additional monitoring. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02920749 . Retrospectively registered (date of registration September 2016).

Sources of Variation in Anesthetic Drug Costs.

BACKGROUND: Increasing attention has been focused on health care expenditures, which include anesthetic-related drug costs. Using data from 2 large academic medical centers, we sought to identify significant contributors to anesthetic drug cost variation. METHODS: Using anesthesia information management systems, we calculated volatile and intravenous drug costs for 8 types of inpatient surgical procedures performed from July 1, 2009, to December 31, 2011. For each case, we determined patient age, American Society of Anesthesiologists (ASA) physical status, gender, institution, case duration, in-room provider, and attending anesthesiologist. These variables were then entered into 2 fixed-effects linear regression models, both with logarithmically transformed case cost as the outcome variable. The first model included duration, attending anesthesiologist, patient age, ASA physical status, and patient gender as independent variables. The second model included case type, institution, patient age, ASA physical status, and patient gender as independent variables. When all variables were entered into 1 model, redundancy analyses showed that case type was highly correlated (R = 0.92) with the other variables in the model. More specifically, a model that included case type was no better at predicting cost than a model without the variable, as long as that model contained the combination of attending anesthesiologist and case duration. Therefore, because we were interested in determining the effect both variables had on cost, 2 models were created instead of 1. The average change in cost resulting from each variable compared to the average cost of the reference category was calculated by first exponentiating the ß coefficient and subtracting 1 to get the percent difference in cost. We then multiplied that value by the mean cost of the associated reference group. RESULTS: A total of 5504 records were identified, of which 4856 were analyzed. The median anesthetic drug cost was $38.45 (25th percentile = $23.23, 75th percentile = $63.82). The majority of the variation was not described by our models-35.2% was explained in the model containing case duration, and 32.3% was explained in the model containing case type. However, the largest sources of variation our models identified were attending anesthesiologist, case type, and procedure duration. With all else held constant, the average change in cost between attending anesthesiologists ranged from a cost decrease of $41.25 to a cost increase of $95.67 (10th percentile = -$19.96, 90th percentile = +$20.20) when compared to the provider with the median value for mean cost per case. The average change in cost between institutions was significant but minor ($5.73). CONCLUSIONS: The majority of the variation was not described by the models, possibly indicating high per-case random variation. The largest sources of variation identified by our models included attending anesthesiologist, procedure type, and case duration. The difference in cost between institutions was statistically significant but was minor. While many prior studies have found significant savings resulting from cost-reducing interventions, our findings suggest that because the overall cost of anesthetic drugs was small, the savings resulting from interventions focused on the clinical practice of attending anesthesiologists may be negligible, especially in institutions where access to more expensive drugs is already limited. Thus, cost-saving efforts may be better focused elsewhere.

The cost-utility of sodium oxybate as narcolepsy treatment.

AIMS AND OBJECTIVES: Based on class-I studies, sodium oxybate is regarded as a first-line treatment for both EDS and cataplexy. The cost-effectiveness of sodium oxybate is largely unknown, though. In this study, we estimate the cost-effectiveness of sodium oxybate as treatment for patients with narcolepsy as compared to standard treatment, by calculating incremental cost-effectiveness ratios (cost per quality-adjusted life year, QALY) for patients in a Swedish setting. MATERIALS AND METHODS: Calculations were performed using a Markov model with a 10-year time horizon. The study population consisted of adult patients treated for narcolepsy with cataplexy. Healthcare utilization and quality-adjusted life years (QALYs) for each treatment alternative were calculated assuming no treatment effect on survival. Sensitivity analyses were performed for treatment effectiveness and healthcare cost parameters. RESULTS: The cost per additional quality-adjusted life year was estimated at SEK 563,481. The cost-effectiveness measure was demonstrated to be particularly sensitive to the duration of the relative quality-of-life improvements accruing to patients treated with sodium oxybate. CONCLUSIONS: The estimated cost per additional QALY for the sodium oxybate treatment alternative compared with standard treatment was estimated above the informal Swedish willingness-to-pay threshold (SEK 500,000). The estimated cost per additional QALY obtained here is likely to overestimate the true cost-effectiveness ratio as potentially beneficial effects on productivity of treatment with sodium oxybate were not included (due to lack of data).

Is the anesthesiologist necessary in the endoscopy suite? A review of patients, payers and safety.

The use of propofol for sedation during endoscopy has been increasing, particularly given its association with superior patient satisfaction. Propofol sedation may also allow for higher quality endoscopy exams, increased efficiency of endoscopy suites and most particularly, permit better patient compliance with colonoscopy for colorectal cancer screening. However, propofol is typically provided by anesthesia specialists via monitored anesthesia care, and is associated with significant economic burden. Given the increasing use of monitored anesthesia care, which adds significant costs to endoscopy, payers are likely to react with changes in payer policies. One alternative to monitored anesthesia care is non-anesthesiologist administered propofol, which due to safety concerns and a lack of reimbursement has not been widely adopted in the US.

Midazolam and propofol used alone or sequentially for long-term sedation in critically ill, mechanically ventilated patients: a prospective, randomized study.

INTRODUCTION: Midazolam and propofol used alone for long-term sedation are associated with adverse effects. Sequential use may reduce the adverse effects, and lead to faster recovery, earlier extubation and lower costs. This study evaluates the effects, safety, and cost of midazolam, propofol, and their sequential use for long-term sedation in critically ill mechanically ventilated patients. METHODS: A total of 135 patients who required mechanical ventilation for >3 days were randomly assigned to receive midazolam (group M), propofol (group P), or sequential use of both (group M-P). In group M-P, midazolam was switched to propofol until the patients passed the spontaneous breathing trial (SBT) safety screen. The primary endpoints included recovery time, extubation time and mechanical ventilation time. The secondary endpoints were pharmaceutical cost, total cost of ICU stay, and recollection to mechanical ventilation-related events. RESULTS: The incidence of agitation following cessation of sedation in group M-P was lower than group M (19.4% versus 48.7%, P = 0.01). The mean percentage of adequate sedation and duration of sedation were similar in the three groups. The recovery time, extubation time and mechanical ventilation time of group M were 58.0 (interquartile range (IQR), 39.0) hours, 45.0 (IQR, 24.5) hours, and 192.0 (IQR, 124.0) hours, respectively; these were significantly longer than the other groups, while they were similar between the other two groups. In the treatment-received analysis, ICU duration was longer in group M than group M-P (P = 0.016). Using an intention-to-treat analysis and a treatment-received analysis, respectively, the pharmaceutical cost of group M-P was lower than group P (P <0.01) and its ICU cost was lower than group M (P <0.01; P = 0.015). The proportion of group M-P with unbearable memory of the uncomfortable events was lower than in group M (11.7% versus 25.0%, P <0.01), while the proportion with no memory was similar (P >0.05). The incidence of hypotension in group M-P was lower than group (P = 0.01). CONCLUSION: Sequential use of midazolam and propofol was a safe and effective sedation protocol, with higher clinical effectiveness and better cost-benefit ratio than midazolam or propofol used alone, for long-term sedation of critically ill mechanically ventilated patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN01173443. Registered 25 February 2014.

Propofol use in endoscopic retrograde cholangiopancreatography and endoscopic ultrasound.

Compared to standard endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) are often lengthier and more complex, thus requiring higher doses of sedatives for patient comfort and compliance. The aim of this review is to provide the reader with information regarding the use, safety profile, and merits of propofol for sedation in advanced endoscopic procedures like ERCP and EUS, based on the current literature.

Comparison between the recovery time of alfentanil and fentanyl in balanced propofol sedation for gastrointestinal and colonoscopy: a prospective, randomized study.

BACKGROUND: There is increasing interest in balanced propofol sedation (BPS) titrated to moderate sedation (conscious sedation) for endoscopic procedures. However, few controlled studies on BPS targeted to deep sedation for diagnostic endoscopy were found. Alfentanil, a rapid and short-acting synthetic analog of fentanyl, appears to offer clinically significant advantages over fentanyl during outpatient anesthesia.It is reasonable to hypothesize that low dose of alfentanil used in BPS might also result in more rapid recovery as compared with fentanyl. METHODS: A prospective, randomized and double-blinded clinical trial of alfentanil, midazolam and propofol versus fentanyl, midazolam and propofol in 272 outpatients undergoing diagnostic esophagogastroduodenal endoscopy (EGD) and colonoscopy for health examination were enrolled. Randomization was achieved by using the computer-generated random sequence. Each combination regimen was titrated to deep sedation. The recovery time, patient satisfaction, safety and the efficacy and cost benefit between groups were compared. RESULTS: 260 participants were analyzed, 129 in alfentanil group and 131 in fentanyl group. There is no significant difference in sex, age, body weight, BMI and ASA distribution between two groups. Also, there is no significant difference in recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between two groups. Though deep sedation was targeted, all cardiopulmonary complications were minor and transient (10.8%, 28/260). No serious adverse events including the use of flumazenil, assisted ventilation, permanent injury or death, and temporary or permanent interruption of procedure were found in both groups. However, fentanyl is New Taiwan Dollar (NT$) 103 (approximate US$ 4) cheaper than alfentanil, leading to a significant difference in total cost between two groups. CONCLUSIONS: This randomized, double-blinded clinical trial showed that there is no significant difference in the recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between the two most common sedation regimens for EGD and colonoscopy in our hospital. However, fentanyl is NT$103 (US$ 4) cheaper than alfentanil in each case. TRIAL REGISTRATION: Institutional Review Board of Buddhist Tzu Chi General Hospital (IRB097-18) and Chinese Clinical Trial Registry (ChiCTR-TRC-12002575).

Comparison of propofol-remifentanil versus propofol-ketamine deep sedation for third molar surgery.

This study aimed to compare continuous intravenous infusion combinations of propofol-remifentanil and propofol-ketamine for deep sedation for surgical extraction of all 4 third molars. In a prospective, randomized, double-blinded controlled study, participants received 1 of 2 sedative combinations for deep sedation for the surgery. Both groups initially received midazolam 0.03 mg/kg for baseline sedation. The control group then received a combination of propofol-remifentanil in a ratio of 10 mg propofol to 5 µg of remifentanil per milliliter, and the experimental group received a combination of propofol-ketamine in a ratio of 10 mg of propofol to 2.5 mg of ketamine per milliliter; both were given at an initial propofol infusion rate of 100 µg/kg/min. Each group received an induction loading bolus of 500 µg/kg of the assigned propofol combination along with the appropriate continuous infusion combination . Measured outcomes included emergence and recovery times, various sedation parameters, hemodynamic and respiratory stability, patient and surgeon satisfaction, postoperative course, and associated drug costs. Thirty-seven participants were enrolled in the study. Both groups demonstrated similar sedation parameters and hemodynamic and respiratory stability; however, the ketamine group had prolonged emergence (13.6 ± 6.6 versus 7.1 ± 3.7 minutes, P = .0009) and recovery (42.9 ± 18.7 versus 24.7 ± 7.6 minutes, P = .0004) times. The prolonged recovery profile of continuously infused propofol-ketamine may limit its effectiveness as an alternative to propofol-remifentanil for deep sedation for third molar extraction and perhaps other short oral surgical procedures, especially in the ambulatory dental setting.

Efficiency and safety of inhalative sedation with sevoflurane in comparison to an intravenous sedation concept with propofol in intensive care patients: study protocol for a randomized controlled trial.

BACKGROUND: State of the art sedation concepts on intensive care units (ICU) favor propofol for a time period of up to 72 h and midazolam for long-term sedation. However, intravenous sedation is associated with complications such as development of tolerance, insufficient sedation quality, gastrointestinal paralysis, and withdrawal symptoms including cognitive deficits. Therefore, we aimed to investigate whether sevoflurane as a volatile anesthetic technically implemented by the anesthetic-conserving device (ACD) may provide advantages regarding 'weaning time', efficiency, and patient's safety when compared to standard intravenous sedation employing propofol. METHOD/DESIGN: This currently ongoing trial is designed as a two-armed, monocentric, randomized prospective phase II study including intubated intensive care patients with an expected necessity for sedation exceeding 48 h. Patients are randomly assigned to either receive intravenous sedation with propofol or sevoflurane employing the ACD. Primary endpoint is the comparison of the 'weaning time' defined as the time required from discontinuation of the sedating agent until sufficient spontaneous breathing occurs. Moreover, sedation depth evaluated by Richmond Agitation Sedation Scale and parameters of patient's safety (that is, vital signs, laboratory monitoring of organ function) as well as the duration of mechanical ventilation and overall stay on the ICU are analyzed and compared. An intention-to-treat analysis will be carried out with all patients for whom it will be possible to define a wake-up time. In addition, a per-protocol analysis is envisaged. Completion of patient recruitment is expected by the end of 2012. DISCUSSION: This clinical study is designed to evaluate the impact of sevoflurane during long-term sedation of critically ill patients on 'weaning time', efficiency, and patient's safety compared to the standard intravenous sedation concept employing propofol. TRIAL REGISTRATION: EudraCT2007-006087-30; ISRCTN90609144.

Comparative cost analysis of three different anesthesia methods in gynecological laparoscopic surgery.

In the current study, we assessed and evaluated the costs and benefits of three popular methods of general anesthesia practiced in our department for gynecological laparoscopic surgery in recent years. Sixty adult female patients who underwent elective gynecological laparoscopic surgery under general anesthesia were randomly divided into three groups: group V, group I and group C. In group V, anesthesia was induced intravenously with midazolam, remifentanil, propofol and vecuronium, and maintained with continuous infusion of propofol and remifentanil. In group I, anesthesia was intravenously induced with midazolam, fentanyl, propofol and vecuronium, and maintained with inhaled isoflurane and intravenous bonus of fentanyl. In group C, anesthesia was induced as in group I, but maintained with isoflurane inhalation combined with propofolremifentanil infusion. All patients received vecuronium for muscle relaxation. Perioperative incidences of complications and total anesthesia costs for patients in all groups were recorded. In addition, postoperative satisfaction of the patients was also noted, and similar outcomes of the satisfaction were reported in all 60 patients. Although there was no statistical significance among groups, the incidence of postoperative nausea and vomiting were higher in group C, and the rates of shivering and the needs for analgesics were higher in group V. Anesthesia costs in group I were the lowest. Therefore, it is concluded that the costs of anesthesia induced with midazolam, fentanyl, propofol, vecuronium, and maintained with isoflurane, fentanyl and vecuronium are cheapest, and there is no significant difference in patients' satisfaction and safety among the three above-mentioned methods of anesthesia in our department.

Efficacy and cost analysis of transrectal ultrasound-guided prostate biopsy under monitored anesthesia.

Sedation may result in reduction in pain during transrectal ultrasound (TRUS)-guided prostate biopsies. We aimed to evaluate the efficacy and safety of a combination of propofol and remifentanil infusion during TRUS-guided prostate biopsy and the related increases in health care costs. From January to September 2010, 100 men undergoing a transrectal prostate biopsy were randomized into two groups. In Group 1, 50 patients received a combined infusion of propofol and remifentanil; in Group 2, 50 patients received lidocaine jelly. After TRUS-guided biopsies were performed, pain and patient satisfaction were evaluated by a 10-point visual analog scale (VAS), and a cost-related patient satisfaction questionnaire was completed by all patients. Patients were also asked whether they would be willing to undergo repeat biopsy by the same method. Patients in Group 1 showed a significantly lower VAS score than those in Group 2 (mean VAS score: 0.9±1.1 versus 6.3±2.5; P<0.001). In addition, the patient satisfaction scale was significantly higher in Group 1 (P=0.002). Although the overall cost was significantly higher in Group 1 (P=0.006), patient satisfaction scales considering cost were also higher in this group (P=0.009). A combination of propofol and remifentanil is a safe and effective way to decrease patient pain and increase patient satisfaction during TRUS-guided prostate biopsy. Although the costs were higher in the group that received sedation, as expected, the patients exhibited heightened satisfaction and willingness to repeat biopsies by the same method.

Effect of the Centers for Medicare & Medicaid Services policy about deep sedation on use of propofol.

On 11 December 2009, the Centers for Medicare & Medicaid Services issued a policy stating that deep sedation can only be administered by an anesthesiologist, a certified registered nurse anesthetist, or a trained medical doctor or a doctor of osteopathy not involved in the performance of a medical procedure. Propofol is a popular sedation agent that is usually administered by anesthesia specialists in a service termed monitored anesthesia care (MAC). Monitored anesthesia care adds substantial new fees to procedural sedation. However, available evidence shows that propofol can be used safely by non-anesthesiologists for procedural sedation. The American Society of Anesthesiologists considers that propofol implies deep sedation and should only be administered by anesthesia specialists. The Centers for Medicare & Medicaid Services policy on deep sedation can be viewed as supporting an ongoing conversion to MAC to deliver propofol for procedural sedation. However, the absence of an evidence base supporting a need for MAC to deliver propofol, combined with its high cost, suggests that alternatives to MAC to deliver propofol deserve fair and balanced evaluation.

Analysis of the cost-effectiveness of remifentanil-based general anesthesia: a survey of clinical economics under the Japanese health care system.

PURPOSE: Remifentanil has been available in Japan for 3 years. The use of this new opioid is considered a useful adjuvant to general anesthesia. Knowing the exact cost-effectiveness of remifentanil should lead to improved anesthetic outcomes with a reasonable cost. METHODS: This single-blinded, prospective, randomized study compared the cost of remifentanil-based general anesthesia combined with isoflurane, sevoflurane, or propofol with fentanyl-based conventional techniques in 210 women who underwent breast surgeries. RESULTS: Remifentanil-based general anesthesia was no more expensive than fentanyl-based conventional anesthesia. Postoperative nausea and vomiting was significantly less frequent after remifentanil-based than fentanyl-based anesthesia. CONCLUSION: This study shows that remifentanil-based general anesthesia is no more expensive than conventional fentanyl-based anesthesia under the Japanese health care system because of the small difference in price between remifentanil and fentanyl.

[Comparison of the activity and reliability of intravenous administration of midazolam and dexmedetomidine on sedation levels under epidural anesthesia]. / Epidural anestezi altinda intravenöz midazolam ve deksmedetomidin kullaniminin sedasyon düzeyleri üzerine etkinlik ve güvenirliginin karsilastirilmasi

OBJECTIVES: We aimed to assess the sedative effects of midazolam and dexmedetomidine and their effects on hemodynamics and the cardiovascular system under epidural anesthesia. METHODS: This study included 50 patients. Approval of the ethics committee and written consent from patients were obtained. The patients were separated into two groups to receive dexmedetomidine (D group) or midazolam (M group). Perifix no. 18 was placed in the epidural space from the L(3-4) interspace. After lidocaine 60 mg/3 ml was applied, isobaric bupivacaine 0.5% was given as 1 ml per segment. After block reached the T10 level, midazolam was given to the M group as a bolus of 0.015 mg kg(-1) in 10 minutes until beginning the operation, followed by continuous infusion as 0.1-0.2 mg kg(-1)h(-1) dosage. Dexmedetomidine 1 mcq kg(-1) was given to the D group as a bolus dosage in 10 minutes until beginning the operation, followed by continuous infusion as 0.4-0.7 mcq kg(-1) h(-1) dosage. Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR), SpO(2), Ramsay Sedation Score (RSS), bispectral index (BIS), and respiratory rate (RR) were recorded. Sedative infusion was stopped when skin suture was closed. Adverse effects were also recorded. RESULTS: In group D, MAP was significantly higher and HR was significantly lower than in group M (p<0.05). CONCLUSION: We concluded that both drugs provided good sedation with no respiratory depression, stable hemodynamics and alertness with good cooperation. However, we consider midazolam as the first option due to its cost benefit.