Acta anaesthesiologica Scandinavica
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Acta Anaesthesiol Scand · Mar 2025
Randomized Controlled Trial Multicenter StudyThe adverse effects with ibuprofen after major orthopedic surgeries: A protocol for the PERISAFE randomized clinical trial.
Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for pain treatment after elective hip and knee arthroplasties. However, evidence regarding the incidence of adverse effects with short-term NSAID treatment following surgery is limited. We, therefore, aim to assess the adverse effects with an eight-day postoperative treatment with ibuprofen after elective hip and knee arthroplasties. ⋯ The trial is approved by the Danish Medicine Agency and the Research Ethics Committee (EU CT no. 2022-502, 502-32-00). We plan to submit for publication in a major international peer-reviewed journal and present results at scientific meetings.
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Acta Anaesthesiol Scand · Mar 2025
Randomized Controlled Trial Comparative StudyComparison of plasma concentration and sedative effect of sublingual and intranasal dexmedetomidine in children: A double-blind randomised controlled study.
Pharmacokinetics and sedative effects of sublingual dexmedetomidine have not been established in children. The primary aim was to compare peak plasma concentration, time to reach peak plasma concentration and area under the curve with 2 μg/kg sublingual and intranasal dexmedetomidine. The secondary aims were to compare the depth of sedation, parental separation anxiety, mask acceptance, heart rate changes, analgesic requirements and recovery time with 2 μg/kg sublingual and intranasal dexmedetomidine in children. ⋯ This study compared the pharmacokinetics and sedative effects of sublingual versus intranasal dexmedetomidine in children, finding that intranasal administration resulted in significantly higher peak plasma concentration and faster time to peak concentration. Both routes achieved comparable sedation, parental separation anxiety scores and mask acceptance, with no significant adverse effects observed.
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Acta Anaesthesiol Scand · Mar 2025
Randomized Controlled Trial Comparative StudyIntubating conditions during rapid sequence induction with either rocuronium or suxamethonium in elderly patients. A randomised study.
During rapid sequence induction, either rocuronium 1.0 mg kg-1 or suxamethonium 1.0 mg kg-1 can be administered to facilitate endotracheal intubation. We hypothezised that rocuronium provided a larger proportion of excellent intubating conditions compared to suxamethonium in elderly patients. ⋯ This reports a superiority trial comparing standardised doses of rocuronium and suxamethonium at 60 s for quality of intubating conditions in the rapid sequence context, and this in an elderly cohort. The findings showed no difference between the drugs concerning intubation outcomes, though the onset or time to peak effect was shorter for suxamethonium, again demonstrated in a cohort 80 years old or older.
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Acta Anaesthesiol Scand · Jan 2025
Randomized Controlled Trial Multicenter StudyEfficacy and safety of a 72-h infusion of prostacyclin (1 ng/kg/min) in mechanically ventilated patients with pulmonary infection and endotheliopathy-protocol for the multicenter randomized, placebo-controlled, blinded, investigator-initiated COMBAT-ARF trial.
Acute respiratory failure (ARF) is common in critically ill patients, and 50% of patients in intensive care units require mechanical ventilation [3, 4]. The COVID-19 pandemic revealed that COVID-19 infection induced ARF caused by damage to the microvascular pulmonary endothelium. In a randomized clinical trial, mechanically ventilated COVID-19 patients with severe endotheliopathy, as defined by soluble thrombomodulin (sTM) ≥ 4 ng/mL, were randomized to evaluate the effect of a 72-h infusion of low-dose prostacyclin 1 ng/kg/min or placebo. Twenty-eight-day mortality was 21.9% versus 43.6% in the prostacyclin and the placebo groups, respectively (RR 0.50; CI 0.24 to 0.96 p = .06). The aim of the current trial is to investigate if this beneficial effect and safety of prostacyclin also are present in any patient with suspected pulmonary infection requiring mechanical ventilation and concomitant severe endotheliopathy. ⋯ This trial will investigate the efficacy and safety of prostacyclin vs. placebo for 72-hours in mechanically ventilated patients with any suspected pulmonary infection and severe endotheliopathy, as defined by sTM ≥4 ng/mL. Trial endpoints focus on the potential effect of prostacyclin to reduce 28-day all-cause mortality.
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Acta Anaesthesiol Scand · Jan 2025
Randomized Controlled TrialEffect of intraoperative methadone in robot-assisted cystectomy on postoperative opioid requirements: A randomized clinical trial.
Postoperative pain management is a challenge after robot-assisted cystectomy (RAC). Methadone has a long duration of action, and we therefore hypothesized that a single dose of intraoperative methadone would reduce postoperative opioid requirements and pain intensity in bladder cancer patients undergoing RAC. ⋯ A single dose of intraoperative methadone does not reduce postoperative opioid requirements compared with a single dose of morphine in bladder cancer patients undergoing RAC.