Sugammadex 500mg/5ml solution for injection vials

BACKGROUND: Sugammadex has been reported to lower the incidence of postoperative residual neuromuscular blockade. Despite the advantages, until recently the effects of sugammadex on postoperative pulmonary complications (PPCs) were controversial. We conducted a systematic review and meta-analysis to determine whether reversal with sugammadex was associated with a lower risk of PPCs compared with neostigmine. METHODS: PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to May 2022. Randomized controlled trials (RCTs) and observational studies comparing PPCs in patients receiving sugammadex or neostigmine as reversal agent at the end of surgery were included. The primary outcomes focused on PPCs including desaturation, pneumonia, atelectasis, noninvasive ventilation (NIV) and reintubation. Trial sequential analysis was performed on the primary outcomes to confirm whether firm evidence was reached. RESULTS: Meta-analysis of included studies showed that the rate of desaturation (43.2% vs 45.0%, RR = 0.82; 95% CI 0.63 to 1.05; p = 0.11) were comparable between the two groups. When looking at other primary outcomes, significantly lower risk of pneumonia (1.37% vs 2.45%, RR = 0.65; 95% CI 0.49 to 0.85; p = 0.002), atelectasis (24.6% vs 30.4%, RR = 0.64; 95% CI 0.42 to 0.98; p = 0.04), NIV (1.37% vs 2.33%, RR = 0.65; 95% CI 0.43 to 0.98; p = 0.04) and reintubation (0.99% vs 1.65%, RR = 0.62; 95% CI 0.43 to 0.91; p = 0.01) in the sugammadex group were detected compared with the neostigmine group. CONCLUSIONS: We concluded that sugammadex is more effective at reducing the incidence of PPCs including pneumonia, atelectasis, NIV and reintubation compared with neostigmine. Further evidence, preferably from RCTs, is required to confirm these findings.

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BACKGROUND: Sugammadex, an innovative agent that rapidly and completely reverses rocuronium-induced neuromuscular blockade, may prolong coagulation time and influence postoperative bleeding. This study aimed to investigate the effects of sugammadex on coagulation parameters. METHODS: Cochrane Central Register of Controlled Trials, Embase, and PubMed were searched on September 25, 2024, for randomized control trials (RCTs) examining the impact of sugammadex on coagulation time. RESULTS: Five RCTs involving 1328 participants were included. Four RCTs with 1302 participants provided data for the meta-analysis. Sugammadex was found to prolong prothrombin time (PT) without affecting activated partial thromboplastin time (APTT). CONCLUSIONS: Sugammadex administration may transiently increase PT values without affecting the APTT. Routine coagulation monitoring is not required in healthy individuals; however, individualized assessment should be conducted in high-risk patients. Further studies are warranted to evaluate the coagulation effects of sugammadex in patients with coagulopathies or those receiving anticoagulant therapy. TRIAL REGISTRATION: This study is registered in the PROSPERO database under the ID CRD42024604567.

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Background and Objectives: Metabolic and bariatric surgery (MBS) is practiced worldwide. Sugammadex was proven to have multiple benefits in reversing neuromuscular blockade (NMB) for patients with obesity undergoing MBS, but its effects on complications of various systems are not clear and concrete. Materials and Methods: This systematic review and meta-analysis was conducted as per the PRISMA guidelines and registered on the PROSPERO database (CRD42023491171). A systematic search was conducted in multiple databases for studies comparing sugammadex with neostigmine in MBS. Continuous data are reported as mean differences (MDs) and 95% confidence intervals (CIs). Dichotomous data are reported as relative risks (RRs) and 95% CIs. A two-sided p < 0.05 was considered statistically significant. Trial sequential analysis (TSA) was performed to evaluate the reliability of the conclusions. Results: Nine studies with 633 patients met the inclusion criteria. Compared with those from the neostigmine group, patients from the sugammadex group were characterized by a significantly shorter recovery time from the administration of the study drug to a train-of-four (TOF) ratio of ≥90% (MD [95% CI]: −15.40 [−26.64; −4.15]; I2 = 96.6%; p = 0.0073; n = 380; random effects model), a lower risk of postoperative residual curarization (PORC) (RR [95% CI]: 0.18 [0.09; 0.38]; p < 0.0001; I2 = 27.9%; n = 344; common effect model), postoperative nausea and vomiting (PONV) (RR [95% CI]: 0.67 [0.48; 0.93]; p = 0.0164; I2 = 0%; n = 335; common effect model), and cardiovascular complications (RR [95% CI]: 0.48 [0.26; 0.88]; p = 0.0186; I2 = 14.7%; n = 178; common effect model). TSA confirmed the conclusions regarding the recovery time and PORC risk. Conclusions: In conclusion, our systemic review and meta-analysis with TSA revealed that sugammadex provided a faster and more reliable choice to reverse NMB in patients with obesity undergoing MBS, with a lower risk of PORC. Sugammadex reduced the risk of cardiovascular complications and postoperative nausea and vomiting. However, the conclusions were not confirmed, and, so, further studies may be necessary.

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BACKGROUND: Postoperative nausea and vomiting (PONV) is a common but troublesome complication in patients who undergo laparoscopic bariatric surgery (LBS). Whether sugammadex use is related to the persistent decrease in the occurrence of PONV during postoperative inpatient hospitalization, which is critical for the rehabilitation of patients after LBS, remains unknown. METHODS: The study was based on a randomized controlled trial conducted in an accredited bariatric centre. A total of 205 patients who underwent LBS were included in the analysis. Univariate analysis and multivariable logistic regression model were used to identify the significant variables related to PONV. Then propensity score matching and inverse probability of treatment weighting (IPTW) were employed to compare outcomes between the sugammadex and neostigmine groups. The primary outcome was the incidence of PONV within 48 h after LBS. The secondary endpoints included the severity of PONV, time to first flatus, need for rescue antiemetic therapy, and water intake. RESULTS: The incidence of PONV was 43.4% (89/205) within the first 48 h after LBS. In multivariable analysis, sugammadex use (OR 0.03, 95% CI 0.01-0.09, P < 0.001) was an independent protective factor of PONV. After IPTW adjustment, sugammadex use was associated with lower incidence of PONV (OR 0.54, 95% CI 0.48-0.61, P < 0.001), postoperative nausea (PON) (OR 0.77, 95% CI 0.67-0.88, P < 0.001), and postoperative vomiting (POV) (OR 0.60, 95% CI 0.53-0.68, P < 0.001) within postoperative 48 h. The severity of PON as well as the incidence and severity of POV within the first 24 h were also lower in the sugammadex group (all P < 0.05). Reduced need for rescue antiemetic therapy within the first 24 h, increased water intake for both periods, and earlier first passage of flatus were observed in the sugammadex group (all P < 0.05). CONCLUSIONS: Compared with neostigmine, sugammadex can reduce the incidence and severity of PONV, increase postoperative water intake, and shorten the time to first flatus in bariatric patients during postoperative inpatient hospitalization, which may play a pivotal role in enhanced recovery. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2100052418, http://www.chictr.org.cn/showprojen.aspx?proj=134893 , date of registration: October 25, 2021).

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BACKGROUND: Residual neuromuscular blockade can be associated with serious postoperative complications. Sugammadex is a newer neuromuscular blocking drug (NMBD) reversal agent that rapidly and completely reverses rocuronium. Whether sugammadex has any advantages over neostigmine in morbidly obese patients with obstructive sleep apnea (OSA) is unclear. We investigated whether sugammadex would reduce discharge time from the operating room (OR) compared with neostigmine in morbidly obese patients with OSA undergoing bariatric surgery. METHODS: This was a prospective, double-blinded randomized controlled superiority trial with 2 parallel groups. Patients were randomized 1:1 into reversal of NMBD with sugammadex or neostigmine. Our inclusion criteria were morbidly obese adult patients with OSA undergoing elective bariatric surgery under general anesthesia. Our exclusion criteria were allergy to rocuronium, sugammadex or neostigmine, malignant hyperthermia, hepatic or renal insufficiency, neuromuscular diseases, and an inability to give consent. The primary outcome was the time from administration of the NMBD reversal agent to discharge from the OR. Secondary outcomes included the time from administration of the NMBD reversal agent to the time the patient opened eyes to command, and the time to extubation. The Mann-Whitney test was used to compare the outcomes between treatment groups. RESULTS: We randomized 120 patients into 2 groups of 60 patients. Overall median body mass index (BMI) was 48.1 kg/m 2 ([interquartile range, IQR]) [43.0-53.5]. The time from drug administration to discharge from OR was 13.0 minutes [10.0-17.0] in the sugammadex group and 13.5 minutes [11.0-18.3] in the neostigmine group ( P = .27). The treatment effect estimate with a bootstrapped 95% confidence interval [CI] for time from admission to discharge from OR was -0.5 [-2.5 to 3]. No differences were observed in postoperative complications and other secondary outcomes. CONCLUSIONS: No difference was observed in OR discharge time in morbidly obese patients with OSA when sugammadex was administered instead of neostigmine.

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BACKGROUND: Sugammadex is well tolerated and effective for reversing neuromuscular blockade (NMB) in adults and children as young as 2 yr old. There is little information on its use in younger children. The aim of this study was to evaluate the efficacy and tolerability of sugammadex in children under 2 yr of age. METHODS: This was a phase IV, randomized, parallel-group, multicenter clinical trial of sugammadex in participants aged birth to less than 2 yr (NCT03909165). Part A was open label and included pharmacokinetic assessments to determine whether sugammadex dose adjustment for part B was necessary based on age. Part B was double-blind and evaluated doses of 2 and 4 mg/kg sugammadex. Participants were randomized to (1) moderate NMB and reversal with 2 mg/kg sugammadex; (2) moderate NMB and reversal with neostigmine + glycopyrrolate or atropine (hereafter, called neostigmine); or (3) deep NMB and reversal with 4 mg/kg sugammadex. The primary efficacy endpoint was time to neuromuscular recovery (TTNMR). The primary efficacy hypothesis was that 2 mg/kg sugammadex would be superior to neostigmine for the reversal of moderate NMB as measured by TTNMR in part B. RESULTS: A total of 138 participants aged 1 to 720 days were treated in parts A and B (2 mg/kg sugammadex, n = 44; 4 mg/kg sugammadex, n = 63; and neostigmine, n = 31). Based on pharmacokinetic assessments in part A, no dose adjustments for age were needed. In part B, TTNMR for reversal of moderate NMB was faster with 2 mg/kg sugammadex than neostigmine (median of 1.4 min vs. 4.4 min; hazard ratio, 2.40; 95% CI, 1.37 to 4.18; P = 0.0002). A 4-mg/kg dose of sugammadex achieved rapid TTNMR for reversal of deep NMB with a median of 1.1 min (parts A and B). The percentage of participants with one or more adverse events (parts A and B) was similar for sugammadex and neostigmine. No deaths, drug-related serious adverse events, or hypersensitivity or anaphylaxis events were reported. CONCLUSIONS: In children less than 2 yr old, 2 mg/kg sugammadex reversed moderate NMB faster than neostigmine, and 4 mg/kg sugammadex rapidly reversed deep NMB. Sugammadex doses of 2 and 4 mg/kg were well tolerated.

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