scholarly journals Response to: ‘Postoperative pulmonary complications, pulmonary and systemic inflammatory responses after lung resection surgery with prolonged one-lung ventilation. Randomised controlled trial comparing intravenous and inhalational anaesthesia’

2018 ◽  
Vol 120 (2) ◽  
pp. 411-412 ◽  
Author(s):  
E. Murphy ◽  
B. Shelley
Keyword(s):  
Randomised Controlled Trial ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Lung Resection ◽  
Lung Ventilation ◽  
Pulmonary Complications ◽  
Postoperative Pulmonary Complications ◽  
One Lung Ventilation ◽  
Inhalational Anaesthesia ◽  
Randomised Controlled

scholarly journals Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Kate Leslie ◽  
Matthew T. V. Chan ◽  
Jai N. Darvall ◽  
Anurika P. De Silva ◽  
Sabine Braat ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Neuromuscular Blockade ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Pulmonary Complications ◽  
Trial Registration ◽  
Postoperative Pulmonary Complications ◽  
Link Type ◽  
Randomised Controlled ◽  
Intrathoracic Surgery

Abstract Background Sugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications. Methods Patients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital). Results Among 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5–4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67). Conclusions A large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible. Trial registration Prospectively registered at the Australian and New Zealand Clinical Trials Registry (ACTRN12620001313921) on December 7, 2020. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true.

The effects of prolonged inspiratory time during one-lung ventilation: a randomised controlled trial

Anaesthesia ◽  
2013 ◽  
Vol 68 (9) ◽  
pp. 908-916 ◽  
Author(s):  
S. M. Lee ◽  
W. H. Kim ◽  
H. J. Ahn ◽  
J. A. Kim ◽  
M. K. Yang ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Lung Ventilation ◽  
Inspiratory Time ◽  
One Lung Ventilation ◽  
Randomised Controlled

scholarly journals Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine (The P- PERSoN Trial) – Pilot Data Following Early Termination of a Prospective, Blinded, Randomised Trial.

2021 ◽  
Author(s):  
Benjamin Luke Olesnicky ◽  
Matthew Doane ◽  
Clare Farrell ◽  
Greg Knoblanche ◽  
Anthony Delaney
Keyword(s):  
Randomised Controlled Trial ◽  
Ordinal Data ◽  
Neuromuscular Block ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Pulmonary Complications ◽  
Residual Paralysis ◽  
Postoperative Pulmonary Complications ◽  
Double Blind ◽  
Randomised Controlled

Abstract Background: Residual paralysis following anaesthesia is common and can lead to postoperative morbidity. While sugammadex has been shown to be effective in minimising residual paralysis, uncertainty exists as to whether its use reduces any associated morbidity. We designed this trial to determine if the use of sugammadex for the reversal of intraoperative aminosteroid neuromuscular blockade results in improvements in postoperative pulmonary complications, complications in the recovery unit, postoperative nausea and vomiting, and patient satisfaction, when compared to reversal with neostigmine. Methods: A prospective, double-blind, randomised controlled trial in adult patients admitted for surgical operations at two Australian hospitals between December 2018 and March 2019 was performed comparing the reversal of neuromuscular paralysis using sugammadex 2mg/kg versus neostigmine 50mcg/kg. Statistical analysis of continuous data was performed using two tailed t-tests, with categorical and ordinal data was assessed by Chi-squared analysis. Results: The trial was terminated due to a combination of resource constraints and the 2019 novel coronavirus disease (COVID-19) pandemic. Of 51 patients screened, 33 were eligible for participation and 30 subsequently recruited and randomised. All patients received the intended treatment allocated. Data for the primary outcome was obtained in all patients. There was no difference in the rates of postoperative pulmonary complications between the sugammadex and neostigmine groups (0% (0/19) vs 9% (1/11) RR 5.0 (95%CI 0.22-113) p=0.37. There was no difference in any of the secondary outcomes between the groups. Conclusions: The P-PERSoN trial showed no difference in post operative pulmonary complications between sugammadex and neostigmine based reversal of aminosteroid neuromuscular block, but was underpowered to show any difference due to early trial termination. The randomisation and data collection was feasible. We support the need for an adequately resourced and funded randomised controlled trial to address this important clinical question. Trial Registration: The P-PERSoN trial is registered at the Australian and New Zealand Trial Registry (www.anzctr.org.au) # ACTRN12616000063415 and The U.S. National Library of Medicine (www.ClinicalTrials.gov) #NCT02825576

scholarly journals Systemic Oxygen Delivery during One-Lung Ventilation: Comparison between Propofol and Sevoflurane Anaesthesia in a Randomised Controlled Trial

2019 ◽  
Vol 8 (9) ◽  
pp. 1438
Author(s):  
Tae Soo Hahm ◽  
Heejoon Jeong ◽  
Hyun Joo Ahn
Keyword(s):  
Randomised Controlled Trial ◽  
Oxygen Delivery ◽  
Controlled Trial ◽  
Lung Ventilation ◽  
Arterial Oxygen ◽  
One Lung Ventilation ◽  
Systemic Oxygen Delivery ◽  
Patient Status ◽  
Systemic Oxygen ◽  
Randomised Controlled

Systemic oxygen delivery (DO2) is a more comprehensive marker of patient status than arterial oxygen saturation (SaO2), and DO2 in the range of 330–500 mL min−1 is reportedly adequate during anaesthesia. We measured DO2 during one-lung ventilation (OLV) for thoracic surgery—where the risk of pulmonary shunt is significant, and hypoxia occurs frequently—and compared sevoflurane and propofol, the two most commonly used anaesthetics in terms of DO2. Sevoflurane impairs hypoxic pulmonary vasoconstriction. Thus, our hypothesis was that propofol-based anaesthesia would show a higher DO2 value than sevoflurane-based anaesthesia. This was a double-blinded randomised controlled trial conducted at a university hospital from 2017 to 2018. The study population consisted of patients scheduled for lobectomy under OLV (N = 120). Sevoflurane or propofol was titrated to a bispectral index of 40–50. Haemodynamic variables were measured during two-lung ventilation (TLV) and OLV at 15 and 45 min (OLV15 and OLV45, respectively) using oesophageal Doppler monitoring. The mean DO2 (mL min−1) was not different between the sevoflurane and propofol anaesthesia groups (TLV: 680 vs. 706; OLV15: 685 vs. 703; OLV45: 759 vs. 782, respectively). SaO2 was not correlated with DO2 (r = 0.09, p = 0.100). Patients with SaO2 < 94% showed adequate DO2 (641 ± 203 mL min−1), and patients with high SaO2 (> 97%) showed inadequate DO2 (14% of measurements < 500 mL min−1). In conclusion, DO2 did not significantly differ between sevoflurane and propofol. SaO2 was not correlated with DO2 and was not informative regarding whether the patients were receiving an adequate oxygen supply. DO2 may provide additional information on patient status, which may be especially important when patients show a low SaO2.

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