Operating room discharge after deep neuromuscular block reversed with sugammadex compared with shallow block reversed with neostigmine: a randomized controlled trial.

OBJECTIVE: To determine if reversing a deep or moderate block with sugammadex, compared with a shallow block reversed with neostigmine, reduces the time to operating room discharge after surgery and the time spent in the postanesthesia care unit. DESIGN: A randomized controlled trial. SETTING: Monocentric study performed from February 2011 until May 2012. PATIENTS: One hundred consenting women with American Society of Anesthesiologists grade I or II were randomized into 2 groups. INTERVENTION: Laparoscopic hysterectomy was performed under desflurane general anesthesia. For the neostigmine (N) group, 0.45 mg · kg-1 rocuronium was followed by spontaneous recovery. A 5-mg rescue bolus was administered only if surgical evaluation was unacceptable. At the end of surgery, 50 µg · kg-1 neostigmine with glycopyrrolate was administered. For the sugammadex (S) group, a higher intubating rocuronium dose (0.6 mg · kg-1) was followed by 5-mg boluses each time the train-of-four count exceeded 2. Sugammadex (2-4 mg · kg-1) was administered to reverse the block. All patients were extubated after obtaining a train-of-four ratio of 0.9. MEASUREMENTS: The duration between the end of surgery and operating room discharge and the time spent in the postanesthesia care unit. MAIN RESULTS: The time till operating room discharge was shorter and more predictable in group S (9.15±4.28 minutes vs 13.87±11.43 minutes in group N; P=.005). The maximal duration in group S was 22 minutes, compared with 72 minutes in group N. The time spent in the postanesthesia care unit was not significantly different (group S: 47.75±31.77 minutes and group N: 53.43±40.57 minutes; P=.543). CONCLUSION: Maintaining a deep neuromuscular block during laparoscopic hysterectomy reversed at the end of the procedure with sugammadex enabled a faster and more predictable time till operating room discharge than did the classical combination of a shallower block reversed with neostigmine.

Do we really need sugammadex as an antagonist of muscle relaxants in anesthesia?

PURPOSE OF REVIEW: Sugammadex is a selective relaxant-binding agent that is designed to encapsulate rocuronium and chemically similar steroidal muscle relaxants such as vecuronium. This review summarizes recent information on the use of sugammadex in clinical practice. RECENT FINDINGS: The main advantages of sugammadex when compared with conventional anticholinesterase agents are a much faster recovery time and its unique ability to reverse rapidly and efficiently, for the first time, deep levels of neuromuscular blockade. However, there is paucity of evidence-based studies on the benefit of deep neuromuscular block, and then routine administration of sugammadex to reverse any level of block, for example, during laparoscopic surgery. It appears that reduction of costs depends mainly on organizational factors. Finally it must be remembered that sugammadex only works with steroidal nondepolarizing muscle relaxants; therefore neostigmine should not be withdrawn because it is the only reversal agent effective against atracurium or cisatracurium. SUMMARY: Sugammadex offers a significantly faster and more predictable recovery profile than neostigmine. It is now possible to reverse rapidly and efficiently any level of neuromuscular blockade and to avoid the risk of adverse events because of residual paralysis such as critical respiratory events during recovery from anesthesia.

The effect of on-demand vs deep neuromuscular relaxation on rating of surgical and anaesthesiologic conditions in patients undergoing thoracolaparoscopic esophagectomy (DEPTH trial): study protocol for a randomized controlled trial.

BACKGROUND: Deep muscle relaxation has been shown to facilitate operating conditions during laparoscopic surgery. Minimally invasive esophageal surgery is a high-risk procedure in which the use of deep neuromuscular block (NMB) may improve conditions in the thoracic phase as well. Neuromuscular antagonists can be given on demand or by continuous infusion (deep NMB). However, the positioning of the patient often hampers train-of-four (TOF) monitoring. A continuous infusion thus may result in a deep NMB at the end of surgery. The use of neostigmine not only is insufficient for reversing deep NMB but also may be contraindicated for this procedure because of its cholinergic effects. Sugammadex is an effective alternative but is rather expensive. This study aims to evaluate the use of deep versus on-demand NMB on operating, anaesthesiologic conditions, and costs in patients undergoing a two- or three-phase thoracolaparoscopic esophageal resection. METHODS/DESIGN: We will conduct a single-center randomized controlled double-blinded intervention study. Sixty-six patients undergoing a thoracolaparoscopic esophageal resection will be included. Patients will receive either continuous infusion of rocuronium 0.6 mg/kg per hour (group 1) or continuous infusion of NaCl 0.9 % 0.06 ml/kg per hour (group 2). In both groups, on-demand boluses of rocuronium can be given (open-label design). The primary aim of this study is to compare the surgical rating scale (SRS) during the abdominal phase. Main secondary aims are to evaluate SRS during the thoracic phase, to evaluate anesthesiologic conditions, and to compare costs (in euros) associated with use of rocuronium, sugammadex, and duration of surgery. DISCUSSION: This study is the first to evaluate the benefits of deep neuromuscular relaxation on surgical and anaesthesiologic conditions during thoracolaparoscopic esophageal surgery. This surgical procedure is unique because it consists of both an abdominal phase and a thoracic phase taking place in different order depending on the subtype of surgery (a two- or three-stage transthoracic esophagectomy). In addition, possible benefits associated with deep NMB, such as decrease in operating time, will be weighed against costs. TRIAL REGISTRATION: European Clinical Trials Database (EudraCT) number: 2014-002147-18 (obtained 19 May 2014) ClinicalTrials.gov: NCT02320734 (obtained 18 Dec. 2014).

[Sugammadex: something new to improve patient safety or simply a gadget?]. / Le sugammadex : une nouveauté qui s'inscrit dans le cadre de l'amélioration de la sécurité des patients ou un simple gadget ?

The launch on the market of a new compound is always an important event for a specialty, particularly when the mechanism of action is completely new. It is the case with sugammadex, a cyclodextrin able to encapsulate specifically and only nondepolarizing steroidal muscles relaxant, rocuronium or vecuronium. The clinical trials which have been performed for sugammadex approval have demonstrated promising results. Sugammadex is able to rapidly reverse (2-5 min) different levels of neuromuscular blockade: moderate (e.g., T2 recovery), deep (e.g., PTC 1-2 recovery) and also few minutes (3-15) after rocuronium administration. Thus, the sugammadex's onset time is about 10 times more rapid than neostigmine without the need of concomitantly atropine administration. Sugammadex has only been tested in small sample size of patients. Therefore, the exact place in the anesthetic practice, the potential indications, the safety profile on a large-scale, thus remain to determine. In particular, how it will modify our current practices characterized to date by 1) under-use of neuromuscular monitoring, 2) a marginal practice of reversal and 3) a wide use of benzylisoquinolines : atracurium and cis-atracurium? Finally, what will be the medical strategies to justify an additional cost when compared to neostigmine?

Induction with sevoflurane-remifentanil is comparable to propofol-fentanyl-rocuronium in PONV after laparoscopic surgery.

PURPOSE: To compare sevoflurane-remifentanil induction and propofol-fentanyl-rocuronium induction with regards to the frequency of moderate to severe postoperative nausea and vomiting (PONV) in the first 24 hr after laparoscopic day surgery. METHODS: After informed consent, 156 ASA physical status class I to III patients undergoing laparoscopic cholecystectomy or tubal ligation were randomized to either induction with sevoflurane 8%, N(2)O 67% and iv remifentanil 1 to 1.5 microg.kg(-1) or induction with iv fentanyl 2 to 3 microg.kg(-1), propofol 2 mg.kg(-1), and rocuronium 0.3 to 0.5 mg.kg(-1). All patients received iv ketorolac 0.5 mg.kg(-1) at induction and sevoflurane-N(2)O maintenance anesthesia with rocuronium as needed. PONV was treated with iv ondansetron, droperidol, or dimenhydrinate; postoperative pain was treated with opioid analgesics. Patients were followed for 24 hr with regards to PONV and pain. Intubating conditions, induction and emergence times, time to achieve fast-track discharge criteria, and drug costs were measured. RESULTS: No differences were seen between the two groups in their frequencies of 24-hr moderate to severe PONV and postoperative pain, or in their intubating conditions, induction and emergence times, and time to achieve fast-track discharge criteria. Patients undergoing sevoflurane-remifentanil induction received more morphine (11 mg vs 8 mg; P < 0.001) in the postanesthetic care unit. Sevoflurane-remifentanil induction resulted in similar anesthetic and total drug costs for both procedures. CONCLUSION: We did not demonstrate any difference in PONV, pain, or anesthetic/recovery times or costs between the sevoflurane and propofol groups. Sevoflurane-remifentanil induction is a feasible technique for anesthetic induction.

Equi-lasting doses of rocuronium, compared to mivacurium, result in improved neuromuscular blockade in patients undergoing gynecological laparoscopy : [Des doses de durée équivalente de rocuronium, comparé au mivacurium, améliorent la curarisation chez des patientes qui subissent une laparoscopie gynécologique].

PURPOSE: To compare equi-lasting doses of a short-acting (mivacurium) to an intermediate-acting (rocuronium) neuromuscular relaxant, with regard to intubating conditions, efficacy, number of maintenance doses, hemodynamic alterations, adverse events and costs, in patients undergoing laparoscopic gynecological surgery. METHODS: Sixty patients were randomly allocated to receive either 0.2 mg*kg(-1) (3 x ED(95)) mivacurium or 0.5 mg*kg(-1) (1.7 x ED(95)) rocuronium, under propofol/fentanyl anesthesia. T1, first twitch of the train-of-four (TOF) and TOF ratio (T4:T1) were used to evaluate neuromuscular block using the Relaxometer(R) mechanomyograph. The trachea was intubated when T1 was maximally suppressed. Neuromuscular block was maintained at 25% T1 with equi-lasting doses of 0.075 mg*kg(-1) mivacurium or 0.15 mg*kg(-1) rocuronium. RESULTS: Mean (min) +/- SD mivacurium onset time (1.9 +/- 0.4) was longer than that of rocuronium (1.3 +/- 0.3). This did not yield a statistical difference in intubating conditions between the two groups. Interval 25-75% T1 recovery and time to 0.8 TOF recovery were prolonged following rocuronium (11.9 +/- 3.9, 52.6 +/- 15.5 respectively) compared to mivacurium (6.7 +/- 2.3, 39.2 +/- 8.1 respectively). More patients, 22/30, required mivacurium maintenance doses compared to 14/30 patients in the rocuronium group. Arterial blood pressure declined and 13/30 patients manifested erythema following mivacurium administration. The acquisition costs of rocuronium (6.93 Euro/patient) were 23% lower compared to mivacurium (8.96 Euro/patient). CONCLUSION: Equi-lasting doses of rocuronium resulted in favourable intubating conditions more rapidly, improved hemodynamic stability, required less frequent administration of maintenance doses and were not associated with erythema, compared to mivacurium.

Economic aspects of different muscle relaxant regimens.

OBJECTIVE: At a time of cost reduction in medical care efforts to manage the ever-increasing costs of new pharmaceutical drugs become increasingly important. Costs of four different muscle relaxant regimens including the new intermediate-acting neuromuscular blocking drugs (NMBD) cisatracurium and rocuronium will be analyzed. METHODS: Eighty patients undergoing laparoscopic cholecystectomy were prospectively studied. All patients received standardized general anaesthesia with desflurane/fentanyl. Muscle relaxation was achieved with atracurium, cisatracurium, vecuronium, or rocuronium with 20 patients in each group. Intraoperatively muscle relaxants were added to maintain two twitches of the train-of-four (TOF) assessment. RESULTS: There were no differences among the four groups regarding biometric data, duration of surgery and anesthesia, number of patients with reversal of neuromuscular blockade, and time of extubation. Length of stay in the postanesthesia care unit (PACU) and the incidence of side effects were similar in all groups. Total costs of used drugs were significantly lowest in the atracurium-treated patients (per patient: 18.27 Euro) and significantly highest in the cisatracurium group (26.71 Euro) compared with the other groups (vecuronium: 22.61 Euro; rocuronium: 22.63 Euro). CONCLUSION: It is summarized that the use of cisatracurium was associated with higher costs compared to a standard muscle relaxant regimen using atracurium, whereas patient outcome was the same in all study groups. The routine use of the newer NMBDs can only be justified economically, if considerable improvements to clinical practice can be demonstrated.