Ad-hoc preoperative management and respiratory events in pediatric anesthesia during the first COVID-19 lockdown-an observational cohort study.

BACKGROUND: Early pre-anesthetic management for surgery is aimed at identifying risk factors, which notably in children are mostly airway related. The first COVID-19 lockdown opened a unique 'window of opportunity' to study what impact an ad-hoc management strategy would bring to bear on intraoperative respiratory events. METHODS: In this observational cohort study we included all patients with an American Society of Anesthesiology (ASA) Physical Status of I or II, aged 0 to ≤18 years, who underwent elective surgery at our center during the first national COVID-19 lockdown (March 15th to May 31st, 2020) and all analogue cases during the same calendar period of 2017-2019. The primary outcome parameter was a drop in peripheral oxygen saturation (SpO2) below 90% during anesthesia management. The study is completed and registered with the German Clinical Trials Register, DRKS00024128. RESULTS: Given 125 of 796 evaluable cases during the early 2020 lockdown, significant differences over the years did not emerge for the primary outcome or event counts (p>0.05). Events were exceedingly rare even under general anesthesia (n = 3) and non-existent under regional anesthesia (apart from block failures: n = 4). Regression analysis for SpO2 events <90% yielded no significant difference for ad-hoc vs standard preoperative management (p = 0.367) but more events based on younger patients (p = 0.007), endotracheal intubation (p = 0.007), and bronchopulmonary procedures (p = 0.001). CONCLUSIONS: Early assessment may not add to the safety of pediatric anesthesia. As a potential caveat for other centers, the high rate of anesthesia without airway manipulation at our center may contribute to our low rate of respiratory events.

Generic versus reference listed ropivacaine for peripheral nerve blockade: A randomised, triple-blinded, crossover, equivalence study in volunteers.

BACKGROUND: Generic drug preparations do not require the same degree of scrutiny as the originally licensed preparation before they can be approved for clinical use. The permitted tolerance limits for bioequivalent preparations might be associated with clinically relevant differences for drugs with a narrow therapeutic index, such as local anaesthetics. OBJECTIVE: We compared pharmacokinetic and pharmacodynamic characteristics of generic and reference listed or original preparations of ropivacaine. DESIGN: The current healthy volunteer study used a randomised, triple-blinded, cross-over equivalence design. SETTING: Tertiary university hospital, Medical University of Vienna. SUBJECTS: Healthy male volunteers (N=18) aged 18 to 60 years. INTERVENTIONS: A series of three ultrasound-guided ulnar nerve blocks separated by at least 6 days were carried out on each volunteer. Reference listed ropivacaine (NaropinTM) was used for two blocks and a generic preparation of ropivacaine was used for the other block. Sensory block onset and duration were evaluated using loss of pinprick sensation. MAIN OUTCOME MEASURES: Duration of sensory block was the primary outcome. Secondary outcomes included time-to-onset of sensory block, ropivacaine pharmacokinetics from venous blood samples and pH of the preparations. Equivalence was evaluated using the ratios of means and 90% confidence intervals (CIs) of log transformed data. RESULTS: Equivalence was demonstrated for the primary outcome measure, the duration of sensory block [original : generic ratio 1.01 (90% CI 0.87 to 1.16); P < 0.007] and all pharmacokinetic variables. Equivalence could not be concluded for time-to-onset of sensory block [reference : generic ratio 0.80 (90% CI 0.63 to 1.03); P = 0.27], although reproducibility of this variable using our experimental model was lower than for other variables. The generic preparation was significantly more alkaline [difference 0.06 pH units (95% CI 0.04 to 0.07); P < 0.0001]. CONCLUSION: Our finding of equivalence for sensory block duration and key pharmacokinetic variables between a generic and original preparation of ropivacaine is reassuring. The significant, but small, difference in pH is not clinically important. TRIAL REGISTRATION: EudraCT 2019-003148-61, German Clinical Trials Register (DRKS 00017750).