Use of sugammadex in patients with a history of pulmonary disease.

STUDY OBJECTIVE: To evaluate the safety and efficacy of sugammadex for reversal of rocuronium-induced neuromuscular blockade in patients with pulmonary disease. DESIGN: Phase III, randomized, multicenter, parallel-group, comparative, safety-assessor blinded study. SETTING: Nine hospital sites. PATIENTS: 77 ASA physical status 2 and 3 patients, aged ≥ 18 years, with a history of pulmonary disease, and scheduled for surgery with general anesthesia requiring neuromuscular blockade. INTERVENTIONS: Following anesthesia induction, patients received rocuronium 0.6 mg/kg with 0.15 mg/kg maintenance doses as needed. Patients were randomized to receive sugammadex 2 mg/kg or 4 mg/kg after the last rocuronium dose at reappearance of the second twitch. MEASUREMENTS: Safety evaluations included adverse events, laboratory parameters, vital signs, and evidence of recurrent or residual neuromuscular blockade. Efficacy was evaluated as the time from sugammadex administration to recovery of the train-of-four (TOF) ratio to ≥ 0.9. MAIN RESULTS: Safety was comparable between doses, with no evidence of residual or recurrent neuromuscular blockade. Two bronchospasm cases were reported (4 mg/kg group), both in patients with asthma who received desflurane for anesthesia maintenance. Geometric mean (95% confidence interval) times to a TOF ratio of ≥ 0.9 were 2.1 (1.7 - 3.1) min (2 mg/kg) and 1.8 (1.5 - 2.7) min (4 mg/kg). CONCLUSION: Sugammadex 2 mg/kg and 4 mg/kg were well tolerated and effective in patients with a history of pulmonary disease. Bronchospasm is a possibility when administering sugammadex to patients with underlying pulmonary disease.

Clinical testing of the apnea prevention device: proof of concept data.

INTRODUCTION: Narcotic-induced respiratory depression is a major cause of perioperative morbidity and mortality. Current monitoring modalities are inadequate to detect and treat respiratory depression in postoperative patients. Intermittent nursing assessments, even if conducted frequently, may not capture the rapid onset of airway obstruction, apnea, and hypoxia that can occur in many of these patients. Continuous nursing observation, as in an intensive care unit setting, is cost-prohibitive and impractical, given the large number of patients at risk. In an effort to address this problem, the author has created and tested the Apnea Prevention Device (APD), which is designed to detect the onset of hypoxia and instantly intervene to restore respiration and oxygen saturation in narcotized patients. METHODS: The prototype APD used in this study consisted of a laptop computer running custom software, a pulse oximeter, and a nerve stimulator. Oxygen saturation data were acquired by the computer from the pulse oximeter, and stimuli to the patient were delivered either by headphones (verbal prompts) or a nerve stimulator (cutaneous). The APD program was written to analyze oximetry data and when indicated, deliver a series of stimuli of increasing intensity to arouse patients from narcosis. The device was tested on surgical patients in the postanesthesia care unit. An intervention delivered by the APD was scored as a success if the patient took a large tidal volume breath (as evidenced by chest rise) and there was a subsequent increase in oxygen saturation. The APD maintained a data log of oxygen saturations and interventions. In a subset of patients, it was possible to compare the functioning of the APD with routine nursing care. RESULTS: A total of 125 interventions were delivered by the APD to 10 patients with a 97% success rate. The depth of desaturations was less when the APD was in use than when patients received routine 1:1 nursing care. When the APD was functioning, the frequency with which nurses prompted the subjects to breathe was dramatically reduced. DISCUSSION: This study demonstrates that the prototype APD can successfully treat narcotic-induced respiratory depression in postoperative patients and does so in a manner that is superior to that provided by routine 1:1 nursing care. Such a device has the potential to decrease the morbidity associated with narcotic-induced respiratory depression in postoperative patients.

Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine.

BACKGROUND: Rocuronium in intubation doses provides similar intubation conditions as succinylcholine, but has a longer duration of action. This study compared time to sugammadex reversal of profound rocuronium-induced neuromuscular block with time to spontaneous recovery from succinylcholine. METHODS: One hundred and fifteen adult American Society of Anesthesiologists Class I-II surgical patients were randomized to this multicenter, safety-assessor-blinded, parallel group, active-controlled, Phase IIIa trial. Anesthesia was induced and maintained with propofol and an opioid. Neuromuscular transmission was blocked and tracheal intubation facilitated with 1.2 mg/kg rocuronium or 1 mg/kg succinylcholine. Sugammadex (16 mg/kg) was administered 3 min after rocuronium administration. Neuromuscular function was monitored by acceleromyography. The primary efficacy endpoint was the time from the start of relaxant administration to recovery of the first train-of-four twitch (T(1)) to 10%. RESULTS: One hundred and ten patients received study treatment. Mean times to recovery of (T(1)) to 10% and (T(1)) to 90% were significantly faster in the rocuronium-sugammadex group (4.4 and 6.2 min, respectively), as compared with the succinylcholine group (7.1 and 10.9 min, respectively; all P < 0.001). Timed from sugammadex administration, the mean time to recovery of (T(1)) to 10%, (T(1)) to 90%, and the train-of-four (T(4)/T(1)) ratio to 0.9 was 1.2, 2.9, and 2.2 min, respectively. Reoccurrence of the block was not observed. There were no serious adverse events related to study treatments. CONCLUSION: Reversal of profound high-dose rocuronium-induced neuromuscular block (1.2 mg/kg) with 16 mg/kg sugammadex was significantly faster than spontaneous recovery from 1 mg/kg succinylcholine.

Laser resection of the prostate: implications for anesthesia.

Holmium:yttrium-aluminum-garnet and potassium-titanyl-phosphate lasers make it possible to perform transurethral prostate resection with almost no absorption of irrigant and minimal blood loss. Subarachnoid block is usually administered for classical transurethral resection of the prostate, so that the patient can be monitored for the onset of transurethral resection of the prostate syndrome secondary to irrigant absorption. New laser resection techniques may allow the patient and anesthesiologist to choose options most appropriate for the patient's medical conditions and preference. In this study, we review the urologic literature to provide an overview of current laser technology for prostate reduction surgery. We also screened this literature for evidence of potential effects on anesthesia care for special patient groups as well as for overall perioperative management. Our findings suggest that the anesthesiologist may now safely offer general anesthesia for endourologic laser surgery, even on an ambulatory basis. This includes patients with cardiovascular disease or receiving continuous anticoagulation therapy. We found no studies specifically aimed at evaluating best anesthetic practices for patients undergoing laser procedures. Therefore, clinical research is needed to better define the risks and benefits of the various anesthetic alternatives.

The effects of surgical case duration and type of surgery on hourly clinical productivity of anesthesiologists.

Surgical duration (hours per case; h/case) and type of surgery (ASA base units per case; base/case) determine the hourly clinical productivity (total ASA units per hour of anesthesia care; tASA/h) for anesthesiology groups. In previous studies, h/case negatively influenced tASA/h, but base/case did not differ significantly. However, when cases are grouped by surgical service, the mean base/case varies. In this study we evaluated the effect of h/case and base/case on tASA/h when these are grouped by surgical services. Data from one calendar year were collected from an academic anesthesiology department's billing database. All surgical cases for which the anesthesiology department provided care were included. Cases performed outside the main operating room, e.g., remote sites or obstetrics, were excluded. Any care not billed with ASA units was also excluded. Mean base/case and h/case were determined. For each service, tASA/h was calculated by dividing the sum of base/case and (4 x h/case) by h/case. A total of 12,769 cases were performed by 19 different surgical services. Mean base/case was 6.1 U, with a range of 4.0 U (orthopedics) to 16.0 U (cardiothoracic). Mean h/case was 2.9 h, with a range of 0.9 h (otolaryngology pediatric) to 5.4 h (orthopedic spine). Mean tASA/h was 6.35 U/h, with a range of 5.01 U/h (plastic surgery) to 9.71 U/h (otolaryngology pediatric). The services with high base/case did not necessarily have high tASA/h because of the longer h/case. The services with the shortest h/case had the highest tASA/h. The accurate prediction of both clinical and billing productivity requires inclusion of both base/case and surgical duration data. Anesthesiology groups should consider surgical duration when making strategic decisions.

Lubeluzole and conditioned learning after cerebral ischemia.

Lubeluzole [S-4-(2-benzothiazolylmethylamino)-alpha-((3,4-difluorophenoxy)methyl)-1-piperidineethanol] reduces the severity of cerebral injury in animal models of brain ischemia. Its beneficial effects may include decreased concentration of extracellular glutamate, blockade of sodium and calcium channels, and attenuation of nitric oxide-mediated neuronal death. Previous studies have shown that global cerebral ischemia in rabbits impaired the subsequent acquisition of a trace-conditioned eyeblink reflex. Here, we examined the effect of preischemic treatment with lubeluzole on the acquisition of a trace-conditioned eyeblink response after 6.5 min of global cerebral ischemia. Three groups of rabbits underwent cerebral ischemia: one group underwent ischemia alone (I) and two groups underwent ischemia and also received lubeluzole (L(1), 1.25 mg/kg, and L(2), 2.5 mg/kg). All animals were subsequently trained using classical trace conditioning. Each training session consisted of the presentation of the conditioned stimulus (an 85-dB, 6-kHz auditory tone lasting for 100 ms) followed by a trace interval (a period of 300 ms during which no external stimulus was delivered) followed finally by the delivery of the unconditioned stimulus (a 150-ms puff of air directed at the cornea). We found that animals receiving preischemic administration of 1.25 mg/kg of lubeluzole demonstrated a significantly improved acquisition of the trace-conditioned reflex as compared to animals that did not receive lubeluzole. This finding demonstrates improved long-term neurobehavioral outcome with preischemic administration of 1.25 mg/kg of lubeluzole.

Inclusion of turnover time does not influence identification of surgical services that over- and underutilize allocated block time.

UNLABELLED: Allocation of operating room (OR) block time is an ongoing challenge for OR managers. In this study, we sought to determine whether inclusion or exclusion of turnover time in comparisons of block utilization would identify different surgical services as under- or overused. For a 13-mo period, we evaluated data extracted from the OR information system of a large academic medical center. During that time period, 15 surgical services performed 12,245 surgical procedures. Allocated block hours, number of first cases performed, total number of cases, and average case durations were determined. The average turnover time for each service was determined by a manual, case-by-case review of data from 1 mo. Raw utilization (RU; case durations only) and adjusted utilization (AU; case duration plus turnover time) were calculated for each service. Turnover time was credited to the service performing surgery after room turnover. Case du-ration was limited to surgeries performed during resource hours. Two indices of utilization (i.e., the usage rate of the service divided by the overall use of all ORs in the suite) were used to compare services: the RU or AU Index (RUI or AUI). Outliers were services with indices that were >1.15 or <0.85. The RUI identified three services as underutilizers and one service as an overutilizer. Using the AUI, the same outliers were identified, and no new services were identified. Examining the changes in index (between AUI and RUI), the percentage of to-follow cases highly correlated with changes in index (r(2) = 0.60); the average turnover time did not (r(2) = 0.002). Inclusion of turnover time did not change the services that were identified as under- and overutilizer. IMPLICATIONS: Turnover time is difficult to determine from existing operating room information systems. This study determined the use of block time with and without turnover time for each surgical service in a large academic hospital. Turnover time did not change identification of surgical services that over- (one service) or underused (three services) allocated block time.

Comparing clinical productivity of anesthesiology groups.

BACKGROUND: Intergroup comparisons of clinical productivity are important for strategic planning and evaluation of clinical and business operations. However, in a preliminary study, comparisons of two anesthesiology groups using "per full-time equivalent" measurements were confounded by different concurrencies or staffing ratios, whereas measurements based on "per operating room (OR) site," "per case," and "billed American Society of Anesthesiologists (ASA) units per hour of care" permitted meaningful comparisons despite differing concurrencies. The purpose of this study was to determine whether these measurements would allow for meaningful comparisons when applied to multiple groups. METHODS: Annual totals of total ASA units (tASA), 15-min time units, and the number of cases billed, as well as the average number of daily anesthetizing sites (OR sites) staffed and the average number of anesthesiologists required to the staff sites, were collected from each group that participated. All anesthesia care billed with ASA units was included, except for obstetric care. Any clinical service not billed using ASA units was excluded. Productivity measurements (concurrency, tASA/OR site, hours billed per OR site per day, hours billed per case, tASA billed per hour of anesthesia care, and base units per case) were calculated. Median and range for all groups and for private-practice and academic groups were determined. RESULTS: Eleven private-practice and nine academic groups from 12 states participated in the study. Productivity measurements that are influenced by duration of surgery (hours billed per case, tASA billed per hour of anesthesia care) differed significantly between groups, with private-practice groups having shorter duration than academic groups (median hours billed per case, 1.5 2.6, respectively). Although tASA/OR site measurements were similar in private-practice and academic groups, academic groups worked significantly longer hours billed per OR site per day (median, 6.0 h 7.8, respectively) to achieve the same level of tASA/OR site. Hourly billing productivity (tASA billed per hour of anesthesia care) correlated highly with surgical duration (hours billed per case). CONCLUSION: This study demonstrates a method of comparing departmental clinical productivity between anesthesiology groups. Private-practice groups provided care for cases of shorter duration than academic groups. This difference was evident in several productivity measurements.

Low utility of dobutamine stress echocardiograms in the preoperative evaluation of patients scheduled for noncardiac surgery.

UNLABELLED: In this study, we examined the utility of preoperative dobutamine stress echocardiograms (DSE) obtained for 85 patients in accordance with guidelines published by the American College of Cardiology (ACC) and the American Heart Association (AHA). The medical record of each patient was reviewed to identify the clinical criteria that indicated the need for a DSE, the DSE results, therapeutic interventions rendered as a result of the DSE, and any perioperative cardiac morbidity. The DSE was positive for inducible ischemia in 4 patients (4.7%), negative in 74 (87.1%), and nondiagnostic in 7 (8.2%). DSEs that were obtained for 48 patients because of a history of diabetes mellitus, mild angina, or "minor clinical predictors" produced only negative results. Of the four patients with positive DSE results, three underwent coronary angiography, and one of those three underwent bypass grafting before surgery. An additional 29 patients received a preoperative DSE but were excluded from the study because the criteria for ordering the DSE did not meet the ACC/AHA guidelines. No patient had any perioperative morbidity related to myocardial ischemia. The total patient charge for the 85 DSEs obtained at our institution was US$104,635. Use of the ACC/AHA guidelines for preoperative DSEs does not appear to be cost-effective. However, the current algorithm could be significantly improved by altering the criteria for obtaining preoperative DSEs. IMPLICATIONS: This study was a retrospective review of 85 patient charts that found a low cost-effectiveness of using American College of Cardiology/American Heart Association guidelines for obtaining preoperative dobutamine stress echocardiograms. Suggested modifications of these guidelines should improve their specificity with no loss in sensitivity.