Comparison of Sugammadex and Neostigmine on First Spontaneous Breathing and Adverse Effects for Laparoscopic Cholecystectomy

OBJECTIVE: The purpose of the study was to investigate the time from the injection of muscle relaxants to the first spontaneous respiration between sugammadex and conventional reversal for patients undergoing laparoscopic cholecystectomy. METHODS: This study was retrospectively conducted on patients who were diagnosed with gallbladder stone (N802) between January 2014 and April 2017. The data were collected from the electronic medical records of a total of 186 patients (84 patients in the neostigmine group and 102 patients in the sugammadex group). RESULTS: The time required for the first spontaneous respiration in the sugammadex group was shorter than that in the neostigmine group (3.6 min vs 4.9 min; p < 0.05). After the injection of intermediate muscle relaxants, the comparison of heart rate and mean arterial pressure in the sugammadex and neostigmine groups revealed that the heart rate in the neostigmine group was higher than in the sugammadex group after 5 min (p < 0.05). The mean arterial pressure in the neostigmine group was higher than in the sugammadex group after 10 min (p < 0.05). A significant adverse effect of tachycardia was observed in the neostigmine group (p < 0.05), but the frequency of rescue antiemetic in the sugammadex group was significantly higher than in the neostigmine group (p < 0.05). CONCLUSION: In this study, the unwanted effect of neostigmine group was tachycardia; therefore, in the case of patients with hemodynamic instability, sugammadex is recommended. At 12 hours after the injection of sugammadex to patients, more antiemetics were required than in the neostigmine group; therefore, more research should be conducted on postoperative nausea and vomiting.

The Effect and Safety of Dapagliflozin in Patients with Type 2 Diabetes: A Single-Institution Pharmacovigilance Review / 임상당뇨병

BACKGROUND: Dapagliflozin, a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, lowers blood glucose by reducing glucose reabsorption at the proximal renal tubule in an insulin-independent manner. We aimed to evaluate the efficacy and safety of dapagliflozin and to identify the risk factors of adverse drug events in patients with type 2 diabetes. METHODS: As an institutional pharmacovigilance review activity, we reviewed data from medical records of 455 patients with type 2 diabetes who received dapagliflozin therapy from July 2014 to August 2015 in Seoul National University Hospital. We analyzed the changes in laboratory data and examined the characteristics of dapagliflozin users who showed adverse effects. RESULTS: Mean changes in HbA1c and fasting serum glucose level from baseline to second visit were −0.42% (8.07 ± 1.51% to 7.65 ± 1.31%, P < 0.001) and −22.9 mg/dL (167.8 ± 48.5 mg/dL to 144.9 ± 37.6 mg/dL, P < 0.001), respectively. Adverse drug events observed during this study were lower urinary tract symptoms (7.7%), dehydration-related symptoms (6.1%), ketonuria (3.4%), hypoglycemia (3.4%), and urogenital infection (4.2%). Thiazide use, age, insulin use, number of anti-diabetic drugs, gender and history of urogenital infection were the risk factors for adverse drug events (P < 0.05). CONCLUSION: Dapagliflozin significantly improved hyperglycemia in patients with type 2 diabetes without serious adverse drug events. The incidences of adverse drug events were was similar to those ofthat in the previous studies.