Anesthesia Teleconsultation: Quality, Medicoeconomic Interest, and Patient Satisfaction of Preoperative Assessment-A Prospective Observational Study.

Background: Telemedicine can be defined as the use of telecommunication technology for performing medical acts remotely by health professionals. Currently in anesthesia, teleconsultation (TC) is becoming widespread, although the benefit and quality have not been well evaluated. The objective of this study was to assess the quality, the patient satisfaction, as well as the ecological and medicoeconomic impacts of the preanesthesia TC. Methods: This prospective observational multicentric study was approved by the Société Française d'Anesthésie-Réanimation ethics committee. The study took place from October 2020 to March 2021, in eight French health care institutions. Every adult patient requiring TC before elective surgery could be included. Unavailability of videoconferencing for the patient was the main exclusion criteria. Five hundred three (n) patients, scheduled for surgery, were included. Their files were analyzed for quality, 375 were successfully interviewed for the second part of the study evaluating satisfaction and medicoeconomic impact. The study's evaluation criteria were the quality of the TeleMed-Cs, the satisfaction and comprehension for the patient, and the medicoeconomic impact of a remote evaluation compared with the face-to-face consultation with the surgeon. Results: Of the 503 files, 478 (95%) were reviewed and met all the high authority of health quality criteria. The electronic format of records was associated with higher completion rate. The median satisfaction was 10.0 (IQR 8.25-10.0). The cost of a TC in anesthesia was significantly lower than that of a face-to-face surgical consultation with a median cost of 1.49€ (IQR 0.8-1.99) versus 34.81€ (IQR 14.01-91.7) p < 0.001. Conclusions: TC in anesthesia seems to be a good alternative in terms of quality, patient satisfaction, and medicoeconomic gain for our patients. By facilitating access to preoperative evaluation, it could be adopted worldwide and thus reduce surgery-related morbidity and mortality in our patients.

Preoperative Paravertebral Block and Chronic Pain after Breast Cancer Surgery: A Double-blind Randomized Trial.

BACKGROUND: The effectiveness of paravertebral block in preventing chronic pain after breast surgery remains controversial. The primary hypothesis of this study was that paravertebral block reduces the incidence of chronic pain 3 months after breast cancer surgery. METHODS: In this prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, 380 women undergoing partial or complete mastectomy with or without lymph node dissection were randomized to receive preoperative paravertebral block with either 0.35 ml/kg 0.75% ropivacaine (paravertebral group) or saline (control group). Systemic multimodal analgesia was administered in both groups. The primary endpoint was the incidence of chronic pain with a visual analogue scale (VAS) score greater than or equal to 3 out of 10, 3 months after surgery. The secondary outcomes were acute pain, analgesic consumption, nausea and vomiting, chronic pain at 6 and 12 months, neuropathic pain, pain interference, anxiety, and depression. RESULTS: Overall, 178 patients received ropivacaine, and 174 received saline. At 3 months, chronic pain was reported in 93 of 178 (52.2%) and 83 of 174 (47.7%) patients in the paravertebral and control groups, respectively (odds ratio, 1.20 [95% CI, 0.79 to 1.82], P = 0.394). At 6 and 12 months, chronic pain occurred in 104 of 178 (58.4%) versus 79 of 174 (45.4%) and 105 of 178 (59.0%) versus 93 of 174 (53.4%) patients in the paravertebral and control groups, respectively. Greater acute postoperative pain was observed in the control group 0 to 2 h (area under the receiver operating characteristics curve at rest, 4.3 ± 2.8 vs. 2.9 ± 2.8 VAS score units × hours, P < 0.001) and when maximal in this interval (3.8 ± 2.1 vs. 2.5 ± 2.5, P < 0.001) but not during any other interval. Postoperative morphine use was 73% less in the paravertebral group (odds ratio, 0.272 [95% CI, 0.171 to 0.429]; P < 0.001). CONCLUSIONS: Paravertebral block did not reduce the incidence of chronic pain after breast surgery. Paravertebral block did result in less immediate postoperative pain, but there were no other significant differences in postoperative outcomes.

Assessing the antinociceptive effect of nitrous oxide to tetanic stimulation in anaesthetised patients with new intra-operative nociception monitors: An observational study.

BACKGROUND: Nitrous oxide (N2O) has been used since the 19th century for its analgesic, antinociceptive and anxiolytic effects during surgical procedures in awake and anaesthetised patients. However, quantification of noxious stimuli that occur under general anaesthesia is a constant challenge for anaesthesiologists, and recently two new indices have been developed to assess intra-operative nociception. OBJECTIVE: The aim of this study was to quantify with new indices as well as with more classical clinical parameters the antinociceptive effect of N2O during general anaesthesia. DESIGN: Prospective, open label, patient-blinded, observational and descriptive trial. SETTING: Single-centre academic hospital. PARTICIPANTS: Forty American Society of Anesthesiologists' physical status 1 to 3 patients undergoing general anaesthesia for elective abdominal surgery via laparotomy were recruited. MAIN OUTCOMES MEASURES: Intra-operative pain was assessed using a standardised electrical stimulation of the forearm (tetanic stimulation at 70 mA, 100 Hz for 30 s), at 0, 25 and 50% inhaled N2O/O2. Heart rate (HR), mean arterial blood pressure, bispectral index, the analgesia nociception index and the nociception level (NOL) index were used to evaluate intra-operative nociception before and after each standardised tetanic stimulation. RESULTS: There was a 16% reduction of the analgesia nociception index reaction, a 31% reduction of the NOL reaction and a 51% reduction of the HR reaction to a standardised electrical tetanic nociceptive stimulation during administration of 50% N2O. Administration of 50 or 25% inhaled N2O produced the same quality of antinociception based on HR and NOL index analyses. HR and the NOL index were the best parameters to identify the antinociceptive effect of intra-operatively administered N2O. CONCLUSION: In anaesthetised patients, our study demonstrated clinically significant antinociceptive properties of N2O. Our results showed that low concentrations of N2O (25%) are as effective as higher concentrations (50%) to achieve a significant antinociceptive effect. These findings may help decrease negative effects of using higher concentrations of N2O, including its side effects and its environmental pollution. TRIAL REGISTRATION: ClinicalTrials.gov registration identifier: NCT02701478.

Impact of intravenous phenylephrine bolus administration on the nociceptive level index (NOL).

Recently, the nociceptive level index (NOL) was shown to more specifically and sensitively detect noxious stimuli during anesthesia, in comparison to previous methods that relied on such parameters as heart rate (HR) and mean blood pressure (MAP). An ongoing study (NCT#03410485) evaluates the intraoperative combination of both NOL and bispectral (BIS) indices to improve quality of recovery after colorectal surgery. Our ethical committee (REB approval #CER15083) initially agreed on an interim analysis of the data from the first 30 patients. More specifically, this present report analyzed all the intravenous phenylephrine (PE) boluses administered during anesthesia as part of our study protocol to see whether they had a significant impact on NOL values as well as other parameters: HR, MAP, BIS index. For this trial, remifentanil and phenylephrine were given in both groups based on a specific algorithm. All study parameters were recorded electronically. Our analysis for the present specific outcome evaluated NOL index for 30 s before the intravenous PE bolus (1 µg kg-1) was given and until 5 min afterwards. The average NOL values after PE bolus, as well as MAP, HR and BIS indices, were recorded and analyzed. A total of 178 events of PE boluses were identified for 28 patients (two were excluded). Median baseline NOL was 3 (1.8-8.3) CI 95% 5.7-8.7; post-PE bolus: 5.3 (2.7-9.9) (95% CI 6.6-8.9; Wilcoxon matched-pairs signed rank test (WMPSRT), P = 0.0003). When analyzing delta NOL (difference between pre- and post-PE bolus in NOL values) for each patient, the median delta NOL was 2.9 (1.2-6.1) (95% CI 3.6-5.5) with 95% of the subjects keeping a delta NOL under 10. MAP and HR values showed expected significant variations after PE bolus: a slight increase and slight decrease, respectively. BIS index values did not change after PE bolus. Our present results demonstrate that intravenous phenylephrine boluses of 1 µg kg-1 had the expected impact on hemodynamic parameters: a significant but very slight increase in MAP and decrease in HR, which might lack clinical relevance. Our report also demonstrates that these same phenylephrine boluses induce a statistically significant increase of the NOL index which does not seem to have much of a clinical relevance for the novel NOL index used to monitor intraoperative nociception as well as for the more classical BIS index for depth of anesthesia. Nevertheless, doses of intravenous PE bolus used in the present study (1 µg kg-1) might be regarded as smaller than more conventional ones (100-200 µg per bolus). Further studies need to be done with the latter doses.

Reliability of cuff pressure gauges.

Cuff pressure gauges are the only recommended instrument to perform controls on endotracheal tube cuff pressure during anesthesia. No calibration is mandatory for these devices. The aim of this study was to describe the level of conformity of various cuff pressure gauges. The single-center measurements were performed with a cuff pressure calibrator on all cuff pressure gauges that were usually used in the operating room. Seven measurements (repeat three times) on each cuff pressure gauges at different levels of pressures (i.e. 0, 10, 20, 27, 30, 40 and 50 cmH2O) were performed. Our homologation criteria were either the reliability of the leak test (value of cuff pressure gauges maintained at 120 cmH2O during 5 s) or the difference between the values of the cuff pressure tested and the calibrator below 1.3 cmH2O at the range of 20-30 cmH2O. A total of 567 measurements on 27 cuff pressure gauges were performed. Only 30% (n = 8/27) of the cuff pressure gauges reach our homologation criteria. 30% (n = 8/27) failed at the leak test. 48% (n = 13/27) of the cuff pressure gauges tested, had a calibration variation error > 1.3 cmH2O on the levels of pressure between 20 and 30 cmH2O. A minority of cuff pressure gauges went through our homologation criteria. These results demonstrate us that there is a real problem of the reliability and the follow-up of those medical devices. This study suggests to reinforce biomedical engineering control on these devices.

Anesthesia for thoracic ambulatory surgery.

PURPOSE OF REVIEW: Ambulatory surgery plays a major role in cost-effective patient care without compromising patient safety and satisfaction. This concept improves the patient support and decreases the length of stay sometimes until ambulatory surgery. The aim of this review is to examine the current state of the art of anesthesia for thoracic ambulatory surgery. RECENT FINDINGS: Guidelines for enhanced recovery after thoracic surgery (ERATS) have recently been published. They can be safely implemented without increasing hospital readmission or mortality. Video-assisted thoracoscopy may be the best approach within a fast-track program. Anesthetic management should focus on combination of regional analgesia and general anesthesia techniques. General anesthesia should be performed with short acting agent and prevention of residual paralysis. Thoracic epidural analgesia is the gold standard technique for pain control after major thoracic surgery but not compatible with a quick hospital discharge. Thoracic paravertebral block, Serratus plane block, intercostal nerve block, and more recently erector spinae plane block have all been used with success for analgesia in thoracic surgery. CONCLUSION: ERATS program may lead to improved outcomes including decreased length of stay, but it is currently too early to show the impact on thoracic ambulatory surgery that concerned selected patients for lung resection.

Pharmacological strategies in multimodal analgesia for adults scheduled for ambulatory surgery.

PURPOSE OF REVIEW: The present review aims to propose pharmacological strategies to enhance current clinical practices for analgesia in ambulatory surgical settings and in the context of the opioid epidemic. RECENT FINDINGS: Each year, a high volume of patients undergoes ambulatory surgery worldwide. The multimodal analgesia proposed to ambulatory patients must provide the best analgesic effect and patient satisfaction while respecting the rules of safety for ambulatory surgery. The role of nurses, anesthesiologists, and surgeons around said surgery is to relieve suffering, achieve early mobilization and patient satisfaction, and reduce duration of stay in hospital. Currently, and particularly in North America, overprescription of opioids has reached a critical level constituting a 'crisis'. Thus, we see the need to offer more optimal multimodal analgesia strategies to ambulatory patients. SUMMARY: These strategies must combine three key components when not contraindicated: regional/local analgesia, acetaminophen, and nonsteroidal anti-inflammatory drugs (NSAIDs). Adjuvants such as gabapentinoids, N-methyl-D-aspartate receptor modulators, glucocorticoids, α2-adrenergic receptor agonists, intravenous lidocaine might be added to the initial multimodal strategy, however, caution must be used regarding their side effects and risks of delaying recovery after ambulatory surgery. Weaker opioids (e.g. oxycodone, hydrocodone, tramadol) could be used rather than more powerful ones (e.g. morphine, hydromorphone, inhaled fentanyl, sufentanil). This, combined with education about postoperative weaning of opioids after surgery must be done in order to avoid long-term reliance of these drugs.

Evaluating the feasibility and acceptability of an adapted fencing intervention in breast cancer surgery post-operative care: the RIPOSTE pilot randomized trial.

Background: Adapted physical activity programs have shown promising results in reducing the physical, social and psychological side effects associated with breast cancer, but the extent to which they can be effectively adopted, implemented and maintained is unclear. The aim of this study is to use the framework to guide the planning and evaluation of programs according to the 5 following keys: Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate a fencing program under the French acronym RIPOSTE (Reconstruction, Image de soi, Posture, Oncologie, Santé, Thérapie, Escrime) literally in English (Reconstruction, Self-Image, Posture, Oncology, Health, Therapy, Fencing). This program is an innovative intervention focused on improving the quality of life (QoL) of breast cancer surgery patients through fencing. Methods: A convergent mixed methods pilot study was conducted to preliminary evaluate the different RE-AIM dimension of the pilot program. Twenty-four participants who have just undergone surgery for invasive breast cancer were randomly allocated in two groups: one group started immediately after their inclusion (Early RIPOSTE group) and the other started 3 months following their inclusion (Delayed RIPOSTE group). Participants answered a questionnaire at inclusion and at the end of the program on QoL, shoulder functional capacity, fatigue, anxiety-depression and physical activity. Results: RIPOSTE program was able to reach mainly young and dynamic participants, attracted by the originality of fencing and keen to improve their physical condition. Regarding effectiveness, our results suggest a trend to the improvement of QoL, shoulder functional capacity, fatigue and anxiety-depression state, even without any significant differences between the Early RIPOSTE group and the Delayed RIPOSTE group. Discussions: The cooperation, exchanges and cohesion within the group greatly facilitated the adoption of the program, whereas interruptions during school vacations were the main barriers. The intervention was moderately well implemented and adherence to the protocol was suitable. Conclusion: RIPOSTE is an acceptable and effective program for involving breast cancer survivors in physical activity, that needs to be tested at a larger scale to investigate its effectiveness, but has the potential to be transferred and scaled up worldwide.

Arterial Cannulation Simulation Training in Novice Ultrasound Users.

BACKGROUND: Arterial cannulation is an important procedure for hemodynamic monitoring and blood sampling. Traditional radial artery cannulation is performed by using anatomical knowledge and pulse palpation as a guide. Arterial cannulation using ultrasound (US) requires specific training, especially for new US users. We hypothesized that even for new US users, US guidance would facilitate the successful puncture by lower attempts before successful intraluminal cannulation of a simulation model of the radial artery. METHODS: A prospective randomized controlled crossover study was conducted with new US users on a gelatin phantom wrist. Three sessions of training were proposed: US-guided technique with low blood pressure (BP), palpation-guided technique with high BP, and one secondary comparison with low BP. For the 2 first sessions, all volunteers performed each technique but not in the same order. The main criterion was the number of attempts before successful catheterization of the model artery. A secondary criterion was the number of needle movements (the number of attempts plus the number of needle directional changes). RESULTS: Twenty new US users participated in the study. Numbers of attempts before successful catheterization were significantly lower when using the US technique: 1.1 (± 0.4) for US versus 1.6 (± 0.8) for palpation high BP (P = .02) versus 2.5 (± 1.4) for the secondary comparison, palpation low BP (P < .001). All of the participants achieved success after the 12th needle movement for US technique, after the 19th needle movement for palpation high BP, and after the 25th needle movement for the secondary comparison, palpation low BP. The total time before success was not significantly different between the 2 first sequences (US vs palpation high BP). CONCLUSIONS: US technique was more successful than traditional palpation technique for novice US users performing arterial cannulations for the first time. A study in the clinical practice is needed to confirm these results.

The Impact of Classroom Chatter Noise on Comprehension: A Systematic Review.

Communication through discussion and conversations is fundamental to human life; but when such discourse escapes the control of a teacher in the classroom, it becomes little more than chatter. This noise challenges teaching methods and the teaching stance with students. Yet, its impact on comprehension has rarely been studied. The aim of this literature review was to examine the research on the impact of classroom noise generated by chatter on students' comprehension performance. We adopted the PRISMA (Preferred Reporting Items for Systematic Reviews and Metanalysis) guidelines to examine this literature. This review covered a 10-year period (papers written between 2009 and 2019), with nine experimental studies selected from the 2,954 papers screened. In 89% of these nine studies, there were significant comprehension differences on all tests, revealed when comprehension took place in a noisy environment due to chatter. This review indicated an essential need for a field survey to better understand the impact of chatter on comprehension. Other studies are recommended to highlight any correlation between measured chatter and student comprehension in a real classroom environment.

Training novice in ultrasound-guided venipuncture: A randomized controlled trial comparing out-of-plane needle-guided versus free-hand ultrasound techniques on a simulator.

BACKGROUND: Peripheral intravenous access is a common medical procedure, however, it can be difficult to perform in some patients. Success rates have proved greater with ultrasound guidance. Peripheral intravenous access using ultrasound requires specific training, especially for new ultrasound users. To overcome these difficulties, guidance devices on ultrasound probes are able to control the angle of penetration into tissues. We hypothesized that, and particularly for new ultrasound users, the use of a needle guide (NG) paired with the out-of-plane approach would facilitate puncture of a simulation model of vessel more effectively than similar free hand (FH) techniques. METHODS: A prospective controlled randomized study was conducted of new ultrasound users using a guide wire introducer needle on gelatine phantom. After a 30-min lecture, one group performed the FH technique and the other group performed the NG technique both in an out-of-plane approach. The main criterion was the number of attempts before success of catheterization of this model of vessel. RESULTS: Thirty-four nurse anesthetist students participated in the study. The number of attempts before success using the NG technique was significantly lower: 3.7 (±0.9) in the NG group versus 6.7 (±3.3) in the FH group (p = 0.01). In the NG group, 100% of the participants achieved success after the sixth attempt. In the FH group, only 81.25% (n = 13/16) reached success. CONCLUSION: NG technique has been proved to have a steeper learning curve compared with the FH technique. A study on a learning curve in clinical practice is needed to confirm these results.

Quality of life, anxiety, and postoperative complications of patients undergoing breast cancer surgery as ambulatory surgery compared to non-ambulatory surgery: A prospective non-randomized study.

PURPOSE: According to the latest recommendations a minimally invasive approach should be used to manage breast cancer and a global policy for minimizing costs encourages shorter periods of hospitalization. The aim of this study was to investigate the impact of length of hospitalization on quality of life, anxiety and depression and postoperative complications. METHODS: This is a prospective observational study of 412 female patients with breast cancer requiring a first mastectomy or lumpectomy to assess the impact of the length of hospitalization on quality of life (using the European Organization for Research and Treatment of Cancer Quality of Life QLQ30 and BR23 questionnaires) at postoperative day 14 (D+14), levels of anxiety at d-1 and D+1 (according to the Hospital Anxiety and Depression scale) and postoperative state at D+21. RESULTS: Our study included 244 patients that had ambulatory surgery and 124 that had non-ambulatory surgery. Global health status was significantly better for ambulatory surgery patients (adjusted p-value=0.014). There were no significant differences between the two groups for levels of anxiety, pain, lymphoceles and postoperative complications. No cases of nausea and vomiting requiring medical treatment were reported for either group. CONCLUSIONS: Breast cancer surgery can be performed using ambulatory surgery with no significant differences compared to non-ambulatory surgery in terms of quality of life, perioperative anxiety, and postoperative complications. Indeed, our study suggests that ambulatory surgery improves patient outcome. It should be determined whether the mode of hospitalization has any long-term impact on the patient, as a shorter hospitalization period would allow decreasing waiting times.

Non-Fellowship regional anesthesia training and assessment: an international Delphi study on a consensus curriculum.

BACKGROUND AND OBJECTIVES: While there are several published recommendations and guidelines for trainees undertaking subspecialty Fellowships in regional anesthesia, a similar document describing a core regional anesthesia curriculum for non-fellowship trainees is less well defined. We aimed to produce an international consensus for the training and teaching of regional anesthesia that is applicable for the majority of worldwide anesthesiologists. METHODS: This anonymous, electronic Delphi study was conducted over two rounds and distributed to current and immediate past (within 5 years) directors of regional anesthesia training worldwide. The steering committee formulated an initial list of items covering nerve block techniques, learning objectives and skills assessment and volume of practice, relevant to a non-fellowship regional anesthesia curriculum. Participants scored these items in order of importance using a 10-point Likert scale, with free-text feedback. Strong consensus items were defined as highest importance (score ≥8) by ≥70% of all participants. RESULTS: 469 participants/586 invitations (80.0% response) scored in round 1, and 402/469 participants (85.7% response) scored in round 2. Participants represented 66 countries. Strong consensus was reached for 8 core peripheral and neuraxial blocks and 17 items describing learning objectives and skills assessment. Volume of practice for peripheral blocks was uniformly 16-20 blocks per anatomical region, while ≥50 neuraxial blocks were considered minimum. CONCLUSIONS: This international consensus study provides specific information for designing a non-fellowship regional anesthesia curriculum. Implementation of a standardized curriculum has benefits for patient care through improving quality of training and quality of nerve blocks.

Guidelines on muscle relaxants and reversal in anaesthesia.

OBJECTIVES: To provide an update to the 1999 French guidelines on "Muscle relaxants and reversal in anaesthesia", a consensus committee of sixteen experts was convened. A formal policy of declaration and monitoring of conflicts of interest (COI) was developed at the outset of the process and enforced throughout. The entire guidelines process was conducted independently of any industrial funding (i.e. pharmaceutical, medical devices). The authors were required to follow the rules of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE®) system to assess the quality of the evidence on which the recommendations were based. The potential drawbacks of making strong recommendations based on low-quality evidence were stressed. Few of the recommendations remained ungraded. METHODS: The panel focused on eight questions: (1) In the absence of difficult mask ventilation criteria, is it necessary to check the possibility of ventilation via a facemask before muscle relaxant injection? Is it necessary to use muscle relaxants to facilitate facemask ventilation? (2) Is the use of muscle relaxants necessary to facilitate tracheal intubation? (3) Is the use of muscle relaxants necessary to facilitate the insertion of a supraglottic device and management of related complications? (4) Is it necessary to monitor neuromuscular blockade for airway management? (5) Is the use of muscle relaxants necessary to facilitate interventional procedures, and if so, which procedures? (6) Is intraoperative monitoring of neuromuscular blockade necessary? (7) What are the strategies for preventing and treating residual neuromuscular blockade? (8) What are the indications and precautions for use of both muscle relaxants and reversal agents in special populations (e.g. electroconvulsive therapy, obese patients, children, neuromuscular diseases, renal/hepatic failure, elderly patients)? All questions were formulated using the Population, Intervention, Comparison and Outcome (PICO) model for clinical questions and evidence profiles were generated. The results of the literature analysis and the recommendations were then assessed using the GRADE® system. RESULTS: The summaries prepared by the SFAR Guideline panel resulted in thirty-one recommendations on muscle relaxants and reversal agents in anaesthesia. Of these recommendations, eleven have a high level of evidence (GRADE 1±) while twenty have a low level of evidence (GRADE 2±). No recommendations could be provided using the GRADE® system for five of the questions, and for two of these questions expert opinions were given. After two rounds of discussion and an amendment, a strong agreement was reached for all the recommendations. CONCLUSION: Substantial agreement exists among experts regarding many strong recommendations for the improvement of practice concerning the use of muscle relaxants and reversal agents during anaesthesia. In particular, the French Society of Anaesthesia and Intensive Care (SFAR) recommends the use of a device to monitor neuromuscular blockade throughout anaesthesia.

Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients.

BACKGROUND: Sugammadex reverses neuromuscular blockade by chemical encapsulation of rocuronium. This phase IIIA study explored efficacy and safety of sugammadex in infants (28 days to 23 months), children (2-11 yr), adolescents (12-17 yr), and adults (18-65 yr). METHODS: Anesthetized patients (American Society of Anesthesiologists class 1-2) received 0.6 mg/kg rocuronium and were randomized to receive sugammadex (0.5, 1.0, 2.0, or 4.0 mg/kg) or placebo at reappearance of T2. Neuromuscular monitoring was performed using acceleromyography. Primary endpoint was time from sugammadex/placebo administration to recovery of the train-of-four ratio to 0.9. Adverse events and electrocardiograms were recorded, and blood samples were collected for safety and determination of sugammadex and rocuronium plasma concentrations. RESULTS: A dose-response relation was demonstrated in children (n = 22), adolescents (n = 28), and adults (n = 26), but not infants because of the small sample size (n = 8). After placebo, median recovery time of train-of-four to 0.9 was 21.0, 19.0, 23.4, and 28.5 min in infants, children, adolescents, and adults, respectively. After 2.0 mg/kg sugammadex train-of-four 0.9 was attained in 0.6, 1.2, 1.1, and 1.2 min, respectively. The sugammadex plasma concentrations were similar for the children, adolescent, and adult age groups across the dose range. Sugammadex was well tolerated: No reoccurrence of blockade, inadequate reversal, significant QT prolongation, or other abnormalities were observed. CONCLUSIONS: Sugammadex is a new reversal agent that rapidly, effectively, safely, and with similar recovery times reverses rocuronium-induced neuromuscular blockade in children, adolescents, adults, and the small number of infants studied.

Postoperative Clinical Monitoring After Morphine Administration: A Retrospective Multicenter Practice Survey.

BACKGROUND: The objective of this survey was to describe the clinical monitoring practically used after intravenous, subcutaneous or neuraxial (epidural or intrathecal) administration of morphine. METHODS: It was a descriptive, retrospective, multicenter (10 hospitals) survey based on the medical charts' analysis, which evaluated the postoperative clinical monitoring after morphine administration. RESULTS: Morphine was delivered intravenously (69%), intrathecally (19%), epidurally (10%) and/or subcutaneously (12%). Clinical monitoring protocols and protocols for the management of side effects were both present in 60% (n=6/10), only one of the two types of protocols in 10% (n=1/10) and both absent in 30% (n=3/10). Protocols for the management of respiratory depression and consciousness evaluation were present in 70% of cases (n=7/10). These events were reported on medical records without any prescription or protocol in 35% (n=14/40) and 37,5% (n=15/40) respectively. Prescriptions for respiratory rate evaluation and clinical monitoring of consciousness were in agreement with only 20% of the medical data and medical records. Different levels of respiratory rate were observed: 43% (n=3/7) below 8/min, 43% (n=3/7) below 10/min and 14% (n=1/7) below 12/min. Clinical monitoring was not performed in 31% (n=31/100) for consciousness and in 35% (n=35/100) for respiratory rate. Pulse oximeter was used in 48% (n=48/100) of patients. Capnography was never used. Respiratory depression occurred in 1% (n=1/100) of cases. CONCLUSION: This survey emphasizes an important disparity in the prescription of medical monitoring and a lack of use of protocols when morphine is administered. It demonstrates the need for a standardization of protocols according to the existing guidelines.

Biological evaluation of the effect of sugammadex on hemostasis and bleeding.

BACKGROUND: Notification of sugammadex has been supplemented with a section on hemostasis, including a longer clotting time in the first minutes following injection, without any documented clinical consequences. The objective of this observational study was to analyze the effects of sugammadex administration on routine coagulation tests and bleeding in the clinical setting. METHODS: After Institutional Review Board approval, a prospective observational study was conducted between January and December 2011. Adult patients scheduled for laparotomies were analyzed in groups according to the type of reversal (without sugammadex versus 2 or 4 mg/kg sugammadex). There were no changes in our current clinical practice. Blood samples drawn from these patients were standardized at the same time and tested using the same daily calibrated machine. The endpoint was a comparison of the activated partial thromboplastin time (aPTT), prothrombin time (PT), hemoglobin (Hb) level and hematocrit (Ht), immediately before sugammadex administration (H0) and 1 h after neuromuscular block reversal (H1). RESULTS: One hundred and forty-two patients in three groups were included as follows: 11 in the "without sugammadex" group, 64 in the "2 mg/kg sugammadex" group and 67 in the "4 mg/kg sugammadex" group. Results did not differ significantly among the groups. CONCLUSIONS: In this prospective observational study, the use of 2 and 4 mg/kg sugammadex was not associated with a longer clotting time or decreased hemoglobin concentrations. Future prospective investigations should study patients receiving 16 mg/kg sugammadex and/or with abnormal coagulation tests.