Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine.
In our study, fast-track protocol resulted in a shorter time to mobilization, complete feeding, and discharge from hospital. Fast-track protocol did not increase the incidence of complications. However, we consider that our data require further confirmation with powered multicenter national studies.
Background: There are only a few studies involving the use of melatonin for premedication for anaesthesia. The goal of our study was to compare the effects of melatonin and midazolam administered as premedication for laparoscopic cholecystectomy.Methods: This double-blind, placebo-controlled study included 53 patients (ASA I, II) undergoing laparoscopic cholecystectomy under general anaesthesia. The patients were divided into three groups: group 1 (n = 18) included patients receiving 3 mg melatonin the night before and as premedication; group 2 (n = 17) included the patients receiving 3,75 mg midazolam (1/2 of a 7,5 mg tablet) by the same protocol as for melatonin; and group 3 (n = 18) included patients receiving placebo tablets. Preoperatively, the anxiety and sedation scores, as well as the quality of preanaesthetic sleep, were evaluated. Postoperatively, the anxiety and sedation scores and the number of remembered pictures were evaluated at 15 and 60 minutes and 6, 12 and 24 hours respectively. The intra-anaesthetic opioid requirements were also evaluated.Results: Preoperatively the lowest anxiety score was registered in the midazolam group; also the difference between the melatonin and midazolam groups was not significant. In the placebo group the anxiety score was significantly higher as compared with melatonin or midazolam. Postoperatively anxiety scores were lowest in the melatonin group at every time interval. The scores for the remembered pictures were consistently better in the melatonin group. The sedation score was lower in the melatonin group as compared with midazolam, as were the intra-anaesthetic opioid requirements.Conclusions: Melatonin (3 mg) can be successfully used as premedication for laparoscopic cholecystectomy, especially for day case surgery. Advantages over midazolam and placebo include better perioperative anxiolysis, and a better recovery profile as assessed by sedation and memory.
Background
The Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high‐ (HICs) and low‐ and middle‐income countries (LMICs).
Methods
This was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7‐day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparing HICs with LMICs.
Results
A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien–Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59).
Conclusion
Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally.
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