We conducted a single-center, retrospective observational study, including all adult patients admitted to Humanitas Research Hospital, a large university institute placed in Milan (Italy), between 1 January 2016 and 31 December 2019, for non-cardiac surgery under general anesthesia. The study received IRB approval (no. 757/20) from the Humanitas Research Hospital Independent Ethical Committee. Patient written informed consent was waived for this study by the IRB due to its retrospective design and anonymization of data.
The primary objective of the study was to describe real-world practice patterns of NMBAs and NMBA reversals in adult non-cardiac surgery patients. The secondary objective was to describe the factors associated with NMBA reversal and reversal agents.
We included all adult patients undergoing non-cardiac surgery with general anesthesia with endotracheal intubation, and treated with a NMBA (rocuronium, cisatracurium, atracurium, succinylcholine). Exclusion criteria were history of myasthenia gravis or home therapy with pyridostigmine, end-stage renal failure, use of two types of NMBA reversals (both sugammadex and neostigmine).
The intraoperative and perioperative practice followed standard anesthesiologic practice. The use of NMBA, neuromuscular monitoring, or NMBA reversal was not restricted during the study and was at the choice of the caring anesthesiologist.
Intraoperative and perioperative data were collected from the Electronic Health Record (EHR) system of our center, a high surgical-volume teaching hospital (about 800 beds hospital, 25,000 surgeries per year). Data were extracted from EHR repository and anonymized before inclusion in the study. Following DACQORD principles, intraoperative data were processed to verify for consistency and outliers, as well as for completeness and redundancy [9 (link)].
The study followed the STROBE guidelines [10 (link)]. Potential source of bias in the cohort study were identified in selection and reporting bias. Selection biases were considered to have minimal impact in this cohort study. This was due to the nature of EHR analysis data, the study selection criteria, and the large population extracted. Reporting bias may have influenced the quality and completeness of entered data. Some data may be under-reported; however, this type of error is unlikely to shift over time or have significant time trends and is limited by EHR completeness medi-co-legal criteria. We used imputation and sensitivity analyses to detect missing data bias.
Sample size estimation: Assuming a 0.30 mean base proportion across 4 years of rocuronium treatment, 8064 patients per year were needed to obtain a margin of error of 1% with 95% confidence interval.
The primary objective of the study was to describe real-world practice patterns of NMBAs and NMBA reversals in adult non-cardiac surgery patients. The secondary objective was to describe the factors associated with NMBA reversal and reversal agents.
We included all adult patients undergoing non-cardiac surgery with general anesthesia with endotracheal intubation, and treated with a NMBA (rocuronium, cisatracurium, atracurium, succinylcholine). Exclusion criteria were history of myasthenia gravis or home therapy with pyridostigmine, end-stage renal failure, use of two types of NMBA reversals (both sugammadex and neostigmine).
The intraoperative and perioperative practice followed standard anesthesiologic practice. The use of NMBA, neuromuscular monitoring, or NMBA reversal was not restricted during the study and was at the choice of the caring anesthesiologist.
Intraoperative and perioperative data were collected from the Electronic Health Record (EHR) system of our center, a high surgical-volume teaching hospital (about 800 beds hospital, 25,000 surgeries per year). Data were extracted from EHR repository and anonymized before inclusion in the study. Following DACQORD principles, intraoperative data were processed to verify for consistency and outliers, as well as for completeness and redundancy [9 (link)].
The study followed the STROBE guidelines [10 (link)]. Potential source of bias in the cohort study were identified in selection and reporting bias. Selection biases were considered to have minimal impact in this cohort study. This was due to the nature of EHR analysis data, the study selection criteria, and the large population extracted. Reporting bias may have influenced the quality and completeness of entered data. Some data may be under-reported; however, this type of error is unlikely to shift over time or have significant time trends and is limited by EHR completeness medi-co-legal criteria. We used imputation and sensitivity analyses to detect missing data bias.
Sample size estimation: Assuming a 0.30 mean base proportion across 4 years of rocuronium treatment, 8064 patients per year were needed to obtain a margin of error of 1% with 95% confidence interval.
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