Sodium-glucose cotransporter 2 inhibitor-associated perioperative ketoacidosis: a systematic review of case reports.

Although the recommended preoperative cessation period for sodium-glucose cotransporter 2 inhibitors (SGLT2is) changed in 2020 (from 24 h to 3-4 days preoperatively) to reduce the risk of SGLT2i-associated perioperative ketoacidosis (SAPKA), the validity of the new recommendation has not been verified. Using case reports, we assessed the new recommendation effectiveness and extrapolated precipitating factors for SAPKA. We searched electronic databases up to June 1, 2022 to assess SAPKA (blood pH < 7.3 and blood or urine ketone positivity within 30 days postoperatively in patients taking SGLT2i). We included 76 publications with 99 cases. The preoperative SGLT2i cessation duration was reported for 59 patients (59.6%). In all cases with available cessation periods, the SGLT2is were interrupted < 3 days preoperatively. No SAPKA cases with > 2-day preoperative cessation periods were found. Many case reports lack important information for estimating precipitating factors, including preoperative SGLT2i cessation period, body mass index, baseline hemoglobin A1c level, details of perioperative fluid management, and type of anesthesia. Our study suggested that preoperative SGLT2i cessation for at least 3 days could prevent SAPKA. Large prospective epidemiologic studies are needed to identify risk factors for SAPKA.

Airway Management Strategy Using Seldinger Minitracheostomy Kit to Prevent Airway Obstruction after Oral Cancer Surgery: A Retrospective Study.

A minitracheostomy (MTS) is performed after surgery for oral cancer at our institution in patients who are at risk of postoperative airway obstruction. The aim of this study was to evaluate outcomes of preventive airway management with this procedure. A total of 105 patients undergoing preventive airway management with a Seldinger MTS kit after oral cancer surgery between October 2014 and March 2020 were enrolled. Information on patient characteristics, time required for the MTS, duration of tracheal cannula placement, and MTS-related complications was obtained from both the medical and anesthesia records. In addition, the numbers of postoperative instances of tracheotomy between April 2009 and September 2014 and extubation between October 2014 and March 2020 were also counted for a comparison. The time required for an MTS was 3.2±2.6 min. Minor complications, including mild subcutaneous or mediastinal emphysema and bleeding, were found in 5 patients, but all recovered in a short time. The median duration of tracheal cannula placement was 2 days, with a range of from 0 to 8 days. A total of 348 oral cancer surgeries were performed between April 2009 and September 2014. Among patients undergoing these procedures, 111 underwent a tracheostomy (32%), 235 extubation (68%), and 2 sustained intubation. A total of 580 oral cancer surgeries were performed between October 2014 and March 2020. Here, 121 patients underwent a tracheostomy (21%), 105 an MTS (18%), and 354 extubation (61%). The results suggest that an MTS can be performed safely and smoothly with no significant complications. They also suggest that an MTS reduces the need for a full tracheostomy and the risk of airway obstruction after extubation. We conclude that airway management strategy with an MTS is a useful option in preventing airway obstruction following oral cancer surgery.

Anesthetic management of super-elderly patients with remimazolam: a report of two cases.

BACKGROUND: Remimazolam is a newly developed benzodiazepine with more rapid onset and offset of sedation effects than midazolam. We report elderly patients in whom a small dose of remimazolam was successfully used for general anesthesia. CASE PRESENTATION: Two elderly women (patients 1 and 2, aged 95 and 103 years, respectively) underwent hip fracture surgery under general anesthesia guided by bispectral index (BIS). Anesthesia was induced with 1.2 and 1.0 mg/kg/h and maintained with 0.2 and 0.1 mg/kg/h remimazolam, combined with fentanyl and remifentanil in patients 1 and 2, respectively. Their hemodynamics were stable with a small dose of vasopressor, and they awoke soon after the discontinuation of remimazolam without flumazenil reversal. Their postoperative courses were uneventful without any complications. Conversely, the remimazolam dose required to achieve adequate sedation were much lower than expected. CONCLUSION: Remimazolam could be useful in general anesthesia, particularly for super-elderly patients. However, the appropriate dose for induction and maintenance of anesthesia should be carefully considered based on BIS or vital signs.

Effects of intrathecal opioids on cesarean section: a systematic review and Bayesian network meta-analysis of randomized controlled trials.

PURPOSE: We aimed to compare the beneficial and harmful effects of opioids used as adjuncts to local anesthetics in patients undergoing cesarean section under spinal anesthesia. METHODS: We searched electronic databases and ClinicalTrials.gov from their inception until March, 2021 without language restrictions. The primary outcome was the complete analgesia duration (Time to VAS > 0). Data were synthesized using the Bayesian random-effects model. Evidence confidence was evaluated using the Confidence In Network Meta-Analysis. RESULTS: We identified 66 placebo-controlled randomized controlled trials (RCTs) comprising 4400 patients undergoing elective cesarean section. Compared with the placebo, intrathecal opioids (fentanyl, sufentanil, and morphine) significantly prolonged the analgesia duration by 96, 96, and 190 min, respectively (mean difference). Despite morphine ranking first, opioid efficacy was similar; the results were inconsistent with respect to other analgesic outcomes. Except for diamorphine, all opioids were associated with significant increases in the pruritus incidence. Sufentanil and morphine were associated with increases in the respiratory depression incidence. CONCLUSIONS: We confirmed that intrathecal opioids benefit postoperative analgesia. Although morphine seems to be the most appropriate agent, some results were inconsistent, and the evidence confidence was often moderate or low, especially for adverse outcomes. Well-designed RCTs with an evidence-based approach are imperative for determining the most appropriate opioid for cesarean sections.

Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold.

Although a domestic trial in Japan revealed that Absorb bioresorbable vascular scaffold (BVS) has no inferiority to everolimus-eluting stent (EES) cohort in the primary endpoint of the target lesion failure at 12 months, the scaffold/stent thrombosis (ST) rates with the BVS at 24 months were higher than those with the EES (Absorb BVS 3.1% vs. EES 1.5%), the ST rate of 3.1% with Absorb BVS is not an acceptable level in Japan. A cause-of-ST analysis revealed that cases in which diagnostic imaging and ensuing post-dilatation had been performed appropriately had lower ST rates than those without such management (within 1 year: 1.37% vs. 7.69%, from 1 to 2 years: 0.00% vs. 8.33%). Therefore, a further evaluation was needed to confirm that the ST rate with the Absorb BVS would be reduced by a proper implementation procedure. Regulatory approval was given conditionally to initiate rigorous post-marketing data collection in order to ensure the proper use of this device in limited facilities. The One-year Use-Result Survey in Japan for the Absorb BVS revealed no instances of ST. This approach to reducing the premarket regulatory burden of clinical trials and enhancing the post-marketing commitments of medical device regulation is useful for expediting patient access to innovative medical devices.

New Device for Securing Nasotracheal Intubation Tube During Oral and Maxillofacial Surgery.

Since 2018, we have been using a 3D printer to fabricate a proprietary device for fixing nasotracheal tubes. The aim of this retrospective study was to investigate the impact of this nasotracheal intubation (NTI) fixation device. It has been used in 335 patients undergoing general anesthesia for oral and maxillofacial surgeries. No necrosis or permanent tissue damage was observed, and none of the patients developed complications requiring treatment. No unintentional tube-related incidents such as extubation, dislocation of the tube, or disconnection between the tube and the artificial respiration circuit occurred either. This fixation device offers three advantages: safety, no impediment to surgery, and minimal invasiveness. Of these, safety is the most important. The high degree of immobilization it offers makes it possible to prevent injury to the nasal ala when the tracheal tube is tugged to the cranial side. There is also a high degree of immobilization at the connection site between the tracheal tube and anesthesia circuit, making it possible to prevent disconnection due to intraoperative pressure. In addition, safety during fixation is less likely to differ depending on the degree of proficiency of the individual anesthesiologist. The presence of a groove through which the sampling tube of the capnometer can be passed makes it possible to prevent the problem of flexion of the sampling tube, rendering detection impossible during surgery. Thus, use of this fixation device offers the potential to improve immobilization of the tracheal tube and increase intraoperative safety. However, there remain several problems that need to be addressed with this novel device. Further improvements aimed at enhancing safety are planned, therefore.

Intraoperative Coronary Artery Spasm Likely Triggered by Surgical Gallbladder Manipulation: A Case Report.

Although the association between cholecystitis and acute coronary syndrome-like symptoms, including chest pain with electrocardiogram (ECG) changes, has been reported previously, it is unclear whether these symptoms can be provoked by direct stimulation to the gallbladder. We present the case of a 44-year-old man who developed coronary artery spasm (CAS) with ST-segment-elevation followed by nonsustained polymorphic ventricular tachycardia during laparoscopic cholecystectomy. The change in ECG occurred only when the gallbladder was manipulated, suggesting that direct stimulation to the gallbladder can cause CAS. Clinicians should be aware that careful ECG monitoring is necessary, especially while the gallbladder is manipulated.

NMR spectroscopy goes mobile: Using NMR as process analytical technology at the fume hood.

Nuclear magnetic resonance (NMR) is potentially a very powerful process analytical technology (PAT) tool as it gives an atomic resolution picture of the reaction mixture without the need for chromatography. NMR is well suited for interrogating transient intermediates, providing kinetic information via NMR active nuclei, and most importantly provides universally quantitative information for all species in solution. This contrasts with commonly used PAT instruments, such as Raman or Flow-infrared (IR), which requires a separate calibration curve for every component of the reaction mixture. To date, the large footprint of high-field (≥400 MHz) NMR spectrometers and the immobility of superconducting magnets, coupled with strict requirements for the architecture for the room it is to be installed, have been a major obstacle to using this technology right next to fume hoods where chemists perform synthetic work. Here, we describe the use of a small, lightweight 60 MHz Benchtop NMR system (Nanalysis Pro-60) located on a mobile platform, that was used to monitor both small and intermediate scale Grignard formation and coupling reactions. We also show how low field NMR can provide a deceptively simple yes/no answer (for a system that would otherwise require laborious off-line testing) in the enrichment of one component versus another in a kilogram scale distillation. Benchtop NMR was also used to derive molecule specific information from Flow-IR, a technology found in most manufacturing sites, and compare the ease at which the concentrations of the reaction mixtures can be derived by NMR versus IR.

Recurrent aspiration pneumonia due to bilateral associated laryngeal paralysis after tooth extraction under general anesthesia: a case report.

BACKGROUND: Associated laryngeal paralysis is a clinical condition merged with other cranial nerve disorders associated with vocal cord paralysis. It is a rare complication in patients after general anesthesia. Here, we report our experience with a patient who developed associated laryngeal paralysis after oral surgery. CASE PRESENTATION: A healthy 31-year-old man underwent extraction of horizontally impacted wisdom teeth in the bilateral mandible under general anesthesia. During the surgery, no significant changes in respiratory and cardiovascular parameters or neurosurgical abnormalities occurred. After the surgery, the patient was diagnosed with aspiration pneumonia. Furthermore, the results of otorhinolaryngological and neurological examinations led to a diagnosis of a combination of bilateral glossopharyngeal and vagus nerve paralysis, right recurrent nerve paralysis, and right hypoglossal nerve paralysis. In this case, seriously associated peripheral laryngeal paralysis with repeated episodes of aspiration pneumonia improved in approximately 6 months with rehabilitation and vitamin B12 administration, and no complications remained. CONCLUSIONS: We suggest that the anesthesiologist should take care of each procedure minutely. It is important to diagnose cases of nerve palsy as soon as possible to reduce the damage. Having had experience with this case, we believe sharing our experience with anesthesiologists is important.

Successful Airway and Anesthesia Management Using a High-Flow Nasal Cannula in a Fibrodysplasia Ossificans Progressiva Patient During General Anesthesia: A Case Report.

Fibrodysplasia ossificans progressiva (FOP) is a rare hereditary disorder causing neck stiffness, ankylosis of temporomandibular joints, and severe restrictive respiratory dysfunction due to progressive heterotopic ossification of the connective tissue. Herein, we report a case of successful airway and anesthesia management using a high-flow nasal cannula (HFNC) in a 51-year-old man with FOP undergoing partial bone resection of the right greater trochanter of the femur. Although general anesthesia with awake fiberoptic nasotracheal intubation has been described as the gold standard, HFNC may yield another potentially viable option for patients undergoing a surgical procedure that does not involve the airway.

Regulatory approval review of transcatheter mitral valve repair - Difference in the indication between the USA and Japan.

The indication for MitraClip (Abbott Vascular, Santa Clara, CA, USA) in the USA is degenerative mitral regurgitation (DMR), but the Japanese indication includes both DMR and functional mitral regurgitation (FMR), in patients without severe left ventricular dysfunction. One of the reasons for this difference is that the Japanese Circulation Society submitted a formal request to the Japanese government for early approval of MitraClip for both DMR and FMR on the basis of unmet medical need for MR patients resistant to medical therapy, but at prohibitive risk for mitral valve surgery. Here, we describe the regulatory approval review process of MitraClip in Japan. Clinical data from outside Japan indicated that MitraClip provides significant improvements from baseline in New York Heart Association Class and hospitalizations for heart failure due to the reduction of MR grade without adversely affecting long-term prognosis in FMR patients as well as DMR patients. Also, a Japanese domestic trial showed a favorable acute procedural success rate without serious adverse events with MitraClip in both DMR and FMR patients. Further, it is considered in Japan that improvement of MR mechanically is clinically important in both DMR and FMR, in patients without severe left ventricular dysfunction. On the basis of these considerations, the MitraClip was approved in Japan for indications of both DMR and FMR with preserved cardiac function in patients at prohibitive risk for mitral valve surgery.

[Prevention of Postoperative Delirium and Agitation in a Patient with Anti-NMDA Receptor Encephalitis: A Case Report].

A 41-year-old woman with anti-N-methyl-D-aspartate (NMDA) receptor encephalitis, characterized by vari- ous psychiatric disturbances, was scheduled for laparo- scopic salpingo-oophorectomy. Anesthesia was induced with fentanyl, propofol and rocuronium, and maintained with intravenous propofol combined with epidural anesthesia (T10-11). The patient received 20 mEq of MgSO4 after induction. MgSO4 administrations were repeated at the end of surgery and every 12 hours for 48 hours after the operation. The operation was per- formed successfully, without any troubles. Trachea was extubated in the operating room. The cognitive dys- function was not observed postoperatively. There was no complication and no unexpected event postopera- tively. One month after surgery, the patient's clinical symptom began to improve. The resection of tumor is recommended as a thera- peutic treatment ; however, there has been few report of the management of postoperative cognitive dysfunc- tion for patients with NMDA receptor antibodies. These patients were more likely to experience a post- operative cognitive dysfunction associated with a poor outcome. We, therefore, administered magnesium sul- fate, NMDA antagonist to prevent postoperative delir- ium. In the present case, magnesium sulfate might have prevented the incidence of postoperative delirium without any complications. The prophylactic magne- sium administration could prevent postoperative delir- ium and agitation safely.

[Comparison of the efficacy of ropivacaine and that of levobupivacaine for postoperative epidural analgesia in patients undergoing gynecological open abdominal surgery].

BACKGROUND: Postoperative analgesia is important in patients undergoing open abdominal surgery. We prospectively compared the efficacy of ropivacaine and that of levobupivacaine for postoperative epidural analgesia in patients undergoing gynecological open abdominal surgery. METHODS: Fifty-two ASA 1-2 patients scheduled for gynecological open abdominal surgery under combined general and epidural anesthesia were enrolled and randomized into two groups. In ropivacaine group (n = 26) the patients received 0.187% ropivacaine and fentanyl 3.2 microg x ml(-1) for postoperative epidural analgesia. In levobupivacaine group (n = 26) the patients received 0.187% levobupivacaine and fentanyl 3.2 microg ml(-1). Visual analogue scale (resting pain and pain on mobilization), the amount of rescue analgesics and epidural anesthesia related adverse events such as hypotension, nausea and vomiting were observed for 48 hours after surgery. RESULTS: There were no differences in visual analogue scale at all intervals between the two groups. In levobupivacaine group the patients used less amounts of rescue analgesics than ropivacaine group (P = 0.01). There were no differences in the incidences of postoperative hypotension, nausea and vomiting between the two groups. CONCLUSIONS: Both 0.187% ropivacaine and levobupivacaine similarly provide appropriate postoperative epidural analgesia for patients undergoing gynecological open abdominal surgery.

The utility of bispectral index monitoring for sedated patients treated with low-dose remifentanil.

The aim of the present study was to determine the effect of low-dose remifentanil on the monitoring quality of the Bispectral index for mechanically ventilated patients. Twelve patients who underwent elective surgery and required mechanical ventilation post-operatively were enrolled in this study with written informed consent. Eligible patients were divided into two groups. Patients in the remifentanil group received low-dose remifentanil (0.05-0.125 µg/kg/min) and propofol (1-3 mg/kg/h). Patients in the control group received propofol (1-3 mg/kg/h). Levels of sedation were evaluated by both the Richmond Agitation Sedation Scale (RASS) and BIS monitor (A2000-XP, version 4.0, Aspect Medical Systems, Newton, USA). Monitoring quality was assessed by a correlation between RASS and BIS values. These values were assessed by single regression analysis and a P value of <0.05 was considered significant. There was a significant correlation between RASS and BIS values (P = 3 × 10(-12), R (2) = 0.67) in the remifentanil group, but not in the control group (P = 0.50, R (2) = 0.057). The administration of low-dose remifentanil makes BIS a more precise tool for sedated patients under mechanical ventilation in the ICU.

[Patient whose surgery was postponed due to complete atrioventricular block on arrival at operating theater].

An 86-year-old woman with low cardiac function was scheduled to undergo hip fracture surgery. Preoperative electrocardiogram showed complete left bundle brunch block, first degree atrioventricular block, left axis deviation and bigeminy. However, her electrocardiogram had changed to complete atrioventricular block on arrival at operating theater. ACC/AHA guideline on perioperative cardiovascular evaluation and care for non cardiac surgery indicates the assessment of both the urgency of the surgery and cardiac complications. Because complete atrioventricular block is classified to "active cardiac conditions", we decided to postpone the surgery for more detailed evaluation and treatment of cardiac conditions. In spite of the discontinuation of digoxin and carvegilol, complete atrioventricular block continued for a week, and the permanent pacemaker was inserted. The surgery was performed 2 weeks following the insertion of the pacemaker without any problems under combined general and lumbar epidural anesthesia.