Efficacy and safety of the implantation of a single-piece angulated foldable IOL in the sulcus.

PURPOSE: To study the visual results and tolerance of a Zeiss CT Lucia 601P intraocular lens (IOL) implanted in the sulcus after complicated cataract surgery or during IOL exchange for clouded IOL. METHODS: In total, 64 patients who underwent sulcus implantation were recalled to the hospital to undergo subjective and objective refraction, best corrected visual acuity measurement, tonometry, optical coherence tomography, laser flare photometry, biometry, and wavefront aberrometry. RESULTS: In spite of a large variation in preoperative refraction, the target refraction was obtained within 1.5 diopters in approximately 97% of patients and within 0.5 diopter in 53% of patients. Average BCVA was high (Snellen 0.86) and related to concomitant (mostly retinal) pathologies in eyes with poorer visual performance. Wavefront aberrometry showed no evidence of IOL tilting or decentration after long-term implantation in the sulcus. Tonometry was not different from the fellow eye of the patient (p > 0.5). In 53 patients with bilateral pseudophakia, the laser flare photometry was not significantly different from the fellow eye (p < 0.05). CONCLUSION: This study demonstrates that this single-piece angulated foldable acrylic IOL can be considered for implantation in the sulcus. The visual results are favorable, and the IOL can be well-positioned and tolerated in the sulcus. Moreover, there were no safety issues found since there was no evidence of elevated IOP or chronic uveitis.

Patient satisfaction after EDOF intraocular lens implantation in vitrectomized eyes.

PURPOSE: To report patient satisfaction after unilateral/bilateral extended depth-of-focus (EDOF) intraocular lens (IOL) implantation in a young population after vitrectomy. METHODS: Patients that underwent phaco-vitrectomy or phaco following vitrectomy with an AT LARA EDOF IOL, aged between 18 and 75 years, were asked to fill out a questionnaire to assess overall visual quality, near vision quality, and visual disturbances. The questionnaire was based on the Catquest, NAVQ, and APPLES questionnaires. RESULTS: A total of 89 participants (average age 56.7 years) filled out the questionnaire of which 53.9% received a unilateral EDOF IOL. The most common indications for vitrectomy were retinal detachments (38.2%), floaters (36.0%), and epiretinal membranes (16.9%). The Catquest and NAVQ score respectively showed a good overall satisfaction (3.44/4.0), a good intermediate vision (3.55/4.0), and an average near vision (2.75/4.0). The APPLES score showed acceptable visual disturbances. There were no differences between the unilateral and bilateral group, except for a higher spectacle dependency in the unilateral group (40% vs. 10.6%). Participants that underwent vitrectomy in case of floaters reported lower satisfaction rates. Other variables, like the pre-operative refraction, had no impact on both satisfaction and visual disturbances. CONCLUSION: Both unilateral and bilateral implantation of the AT LARA EDOF IOL showed a high satisfaction with no differences between both groups, except for a lower spectacle use in the latter. Hence, The AT LARA seems to be a possible choice in patients undergoing vitrectomy at a younger age, even for unilateral use.

Influence of height on ED95 of intrathecal 2-chloroprocaine for knee arthroscopy: A prospective dose-response clinical trial.

BACKGROUND: Plain 2-chloroprocaine , a rapid acting amino-ester-type local anaesthetic, is used in short ambulatory procedures under spinal anaesthesia. The ED 95 of 2-chloroprocaine for lower limb surgery has not yet been defined. Moreover, patients' body height could influence the effects of the administered dose. OBJECTIVES: The aim of this study was to determine the ED 95 of plain 2-chloroprocaine based on the height of patients undergoing ambulatory knee arthroscopy under spinal anaesthesia using the continual reassessment statistical method (CRM). DESIGN: Prospective, dose-response, double blind, controlled, bi-center, clinical trial. SETTING: One university teaching hospital in Brussels and one general teaching hospital, Braine l'Alleud, Belgium. Université libre de Bruxelles. PATIENTS: ASA I-III (120 patients) scheduled for day-case knee arthroscopy under spinal anaesthesia. INTERVENTIONS: Patients were divided into three groups of 40, each comprising 10 cohorts of 4 patients, according to their respective heights (Group 1: 150-165 cm, Group 2: 166-180 cm, Group 3: 181-195 cm). Each patient enrolled into one of the 3 groups received an intrathecal dose of plain 2-chloroprocaine determined by the CRM. The starting doses for the first cohorts of four were 40 mg in group 1, 45 mg in group 2 and 50 mg in group 3. The doses for subsequent cohorts were determined by CRM of outcomes in all patients in the previous competed cohorts. Anaesthesia was considered successful when there was a lack of pinprick or cold sensation up to T12, the visual analogue scale score for tourniquet pain was < 2 and no pain during surgery. MAIN OUTCOMES: The primary outcome was the success or failure of the block. Side effects were also recorded. RESULTS: ED 95 of 2-chloroprocaine is 40 mg in group 1, 35 mg in group 2, 45 mg in group 3. Groups were different in terms of height and gender ( P  < 0.05) and similar in terms of body mass index and age ( P  > 0.05). CONCLUSION: The ED95 of intrathecal 2-chloroprocaine for patients undergoing ambulatory knee arthroscopy is between 35 and 45 mg. Height could be a factor involved in the calculation, and patient sex could partly explain the nonlinear relation between height and dose. TRIAL REGISTRY NUMBER: Clinicaltrials.gov NCT03882489.

Comparison of equipotent doses of intrathecal hyperbaric prilocaine 2% and hyperbaric bupivacaine 0.5% for elective caesarean section: A prospective, randomised, controlled, two-centre clinical trial.

BACKGROUND: Elective caesarean section is performed mainly under spinal anaesthesia using hyperbaric bupivacaine combined with opioids. Despite rapid onset, good quality anaesthesia, bupivacaine provides a long duration of motor block and is related to maternal hypotension. Current policies appeal for implementation of enhanced recovery procedures after caesarean section. Hyperbaric prilocaine is an intermediate-acting local anaesthetic known for its efficacy in ambulatory surgery. Evidence on the clinical relevance of intrathecal prilocaine use for caesarean section is currently lacking. OBJECTIVES: We aimed to investigate whether hyperbaric prilocaine would offer a shorter motor block and recovery than bupivacaine, when comparing equipotent doses. We also assessed the characteristics of sensory block, maternal haemodynamics and side effects for both mother and newborn. DESIGN: Prospective, randomised, double-blind, controlled, two-centre, clinical trial. SETTING: One university teaching hospital and one general teaching hospital in Brussels, Belgium. PATIENTS: American Society of Anesthesiologists' physical status 2 parturients (n = 40) undergoing caesarean section under spinal anaesthesia. INTERVENTIONS: Patients were randomly assigned to receive spinal anaesthesia using hyperbaric prilocaine 50 mg or hyperbaric bupivacaine 10 mg, both given with sufentanil 2.5 µg and morphine 100 µg. An epidural catheter was introduced as a backup in case of failure. MAIN OUTCOMES: The primary outcome was the motor block regression (modified Bromage scale 1 to 6). Secondary outcomes included sensory block characteristics, first unassisted ambulation, maternal side effects, newborns' parameters and overall satisfaction. RESULTS: Median [IQR] motor block was significantly shorter in the hyperbaric prilocaine group (110 [104 to 150] min versus 175 [135 to 189] min, P = 0.001). First unassisted ambulation was achieved earlier after prilocaine (204.5 [177 to 246.5] min versus 314 [209.25 to 400] min, P = 0.007), and the incidence of maternal hypotension was significantly higher with bupivacaine (P = 0.033). No supplementary epidural analgesia was needed. CONCLUSION: Prilocaine provides shorter motor block, faster recovery and better haemodynamic stability than bupivacaine while offering equivalent surgical anaesthesia. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02973048, EudraCT: 2016-003010-26.

Posterior segment spectral domain oct in the differential diagnosis of bilateral temporal optic neuropathy and its correlation with visual acuity.

PURPOSE: To identify the underlying etiologies and to evaluate the differential diagnostic value of posterior segment spectral domain OCT measurements and their correlation with best-corrected visual acuity (BCVA) in a group of patients with OCT documented bilateral optic neuropathy limited to the temporal quadrants. METHODS: Retrospective study. RESULTS: We included 61 patients: 35 presented with presumed "classic" acquired mitochondrial optic neuropathy (MON) (18 nutritional, 11 toxic, 6 mixed toxic-nutritional) and 2 with suspected hereditary MON. Nine patients were identified as 'MON mimickers' (especially multiple sclerosis), and 4 were found to have a mixed mechanism, while 11 remained undiagnosed. Across all etiologies, the strongest positive relationship between BCVA and tested OCT parameters was with macular GCL (ganglion cell layer) and GCIPL (combined ganglion cell and inner plexiform layer) volumes rather than peripapillary retinal nerve fiber layer (RNFL) thicknesses (all statistically significant). There was an inverse relationship between BCVA and inner nuclear layer (INL) volumes, with significant differences for BCVA and all tested OCT parameters between eyes with and without INL microcystoid lesions. OCT (absolute values and intereye differences) was not helpful in distinguishing between presumed acquired mitochondrial disease and patients with multiple sclerosis without optic neuritis. However, significantly greater intereye differences in global RNFL and inner plexiform layer and GCIPL volumes were found in patients with a previous history of unilateral optic neuritis. CONCLUSIONS: The strongest positive relationship with BCVA was found for macular GCL and GCIPL volumes. OCT could not differentiate between acquired mitochondrial disease and multiple sclerosis without optic neuritis.

Severe Acute Respiratory Syndrome Coronavirus 2 and Pregnancy Outcomes According to Gestational Age at Time of Infection.

We conducted an international multicenter retrospective cohort study, PregOuTCOV, to examine the effect of gestational age at time of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on obstetric and neonatal outcomes. We included all singleton pregnancies with a live fetus at 10 weeks' gestation in which pregnancy outcomes were known. The exposed group consisted of patients infected with SARS-CoV-2, whereas the unexposed group consisted of all remaining patients during the same period. Primary outcomes were defined as composite adverse obstetric outcomes and composite adverse neonatal outcomes. Of 10,925 pregnant women, 393 (3.60%) were infected with SARS-CoV-2 (exposed group). After matching for possible confounders, we identified statistically significant increases in the exposed group of composite adverse obstetric outcomes at >20 weeks' gestation and of composite adverse neonatal outcomes at >26 weeks' gestation (p<0.001). Vaccination programs should target women early in pregnancy or before conception, if possible.

Neuromuscular block in patients 80 years and older: a prospective, controlled study.

BACKGROUND: An increasing number of patients older than 80 years are undergoing anesthesia, but little information is available regarding pharmacodynamic effects of myorelaxants in this population. This study aims to compare the time course of rocuronium neuromuscular block in patients ≥ 80 years with those of younger adults. METHODS: Under total intravenous anesthesia with propofol and sufentanil, time course of a bolus of rocuronium 0.6 mg/kg neuromuscular block was assessed with acceleromyography in patients ≥ 80 and in patients 20-50 years old. Onset time, clinical duration, duration until 90% and 100% recovery of baseline were determined. RESULTS: Data from 32 patients were analyzed, 16 were ≥ 80 years and 16 were 20-50 years old. Demographic data are shown in Table 1. In the group ≥ 80, onset time was 190 s ± 46 s compared to 123 s ± 40 s in the group 20-50, P < 0.001 and the clinical duration was 52 [48-69.5] min and 36 [34-41] min, respectively, P < 0.001. Duration to 90% recovery of baseline was 77.5 [71-88.5] min and duration to 100% recovery of baseline was 91.2 [82.2-98] min in patients ≥ 80 years and the corresponding values in the patients 20-50 years old were 53.5 [49-55.5] min and 59.5 [56.5-70.25] min, respectively, P < 0.001. CONCLUSION: Compared to younger adults rocuronium shifted in patients ≥ 80 years from a rapid onset, intermediate acting compound to a slower onset, long-acting compound. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03551652 (29/05/2018).

Does a balanced colloid decrease perioperative blood loss in paediatric cardiac surgery: A double-blinded randomized controlled trial?

BACKGROUND: Unbalanced fluid solutions cause metabolic acidosis and could be associated with impaired coagulation and increased blood loss. OBJECTIVE: To investigate whether the use of a balanced colloid compared with a saline colloid for peri-operative fluid therapy in children undergoing cardiac surgery is associated with decreased blood loss and exposure to blood products. DESIGN: Double-blinded randomised controlled trial. SETTING: Tertiary children's hospital from 2013 to 2016. PATIENTS: Children older than 29 days and younger than 3 years admitted for cardiac surgery with cardiopulmonary bypass (CPB). Exclusion criteria were emergency cardiac surgery, moribund (American Society of Anesthesiologists 5), Jehovah's witnesses, coagulopathy, renal failure, liver injury, intracranial haemorrhage and electrolyte disturbances. From the 128 patients eligible, 88 were included in the study. INTERVENTION: Random assignment of patients to either a saline colloid (6% hydroxyethyl starch 130/0.4 in 0.9% NaCl) or a balanced-electrolyte colloid (6% hydroxyethyl starch 130/0.4 in an isotonic solution) for CPB priming and intra- and postoperative fluid therapy during the first postoperative 48 h. MAIN OUTCOME MEASURE: The primary outcome measure was calculated blood loss until the third postoperative day (POD3). RESULTS: A total of 44 patients were included in each study arm. Calculated blood loss at POD3 was not significantly different between the groups (saline colloid 19.9 [IQR 13.8 to 26.1] ml kg-1 versus balanced colloid 15.9 [IQR 9.0 to 25.3 ml kg-1], P = 0.409). Secondary outcomes related to bleeding, exposure to blood products and coagulation were not different between groups. There was also no difference in length of mechanical ventilation, intensive care and hospital length of stay between groups. CONCLUSION: The use of a balanced colloid for peri-operative fluid therapy compared with a saline one is not associated with decreased blood loss or exposure to blood products. TRIAL REGISTRATION: EudraCT identifier: 2012-006034-17 and ClinicalTrial.gov identifier: NCT02584868.

EVALUATION OF TUMOR NECROSIS FACTOR INHIBITOR THERAPY IN SUSAC SYNDROME.

PURPOSE: To evaluate the effect of tumor necrosis factor (TNF) inhibitor therapy on ocular relapses in patients with Susac syndrome. METHODS: Multicenter retrospective cohort study of patients diagnosed with Susac syndrome according to classical clinical criteria. We evaluated the disease activity before and after introduction of anti-TNF therapy and its value as a steroid-sparing agent. RESULTS: Five patients were included. All were initially treated with a combination of corticosteroids and classical immunosuppressive drugs. Infliximab was started in three patients, and adalimumab was started in two patients. Patients had on average 5 ocular relapses during a mean follow-up time of 2.59 years before introducing a TNF inhibitor, corresponding with on average 1.93 relapses per year. After the introduction of an anti-TNF agent, this number was reduced by factor 5.51 to an average of 0.35 relapses per year for a mean follow-up of 2.86 years (P = 0.10). Before anti-TNF introduction ocular relapses occurred at a mean daily dose of 34 mg of prednisone, whereas with anti-TNF treatment, corticosteroid administration could be completely stopped in four patients with one patient still needing 5 mg daily (P = 0.10). Infliximab and adalimumab generally were well tolerated, and no serious adverse events were reported. CONCLUSION: Although not statistically significant, our results suggest that anti-TNF therapy can be a valuable option for the treatment of ocular Susac syndrome and may especially be considered in those patients unresponsive to more conventional immunosuppressive treatment.

Pleth variability index versus pulse pressure variation for intraoperative goal-directed fluid therapy in patients undergoing low-to-moderate risk abdominal surgery: a randomized controlled trial.

BACKGROUND: Goal-directed fluid therapy (GDFT) based on dynamic indicators of fluid responsiveness has been shown to decrease postoperative complications and hospital length of stay (LOS) in patients undergoing major abdominal surgery. The usefulness of this approach still needs to be clarified in low-to-moderate risk abdominal surgery. Both pulse-pressure variation (PPV) and pleth variability index (PVI) can be used to guide GDFT strategies. The objective of this prospective randomized controlled trial was to determine if the use of PVI guided GDFT, when compared to PPV guided GDFT, would lead to similar hospital LOS in patients undergoing low-to-moderate risk surgery. Secondary outcomes included amount of fluid administered and incidence of postoperative complications. METHODS: Patients were randomized into either PVI or PPV guided GDFT groups. Both received a baseline 2 ml kg- 1 h- 1 Lactated Ringer infusion. Additional fluid boluses consisted of 250 mL of colloid that was infused over a 10 min period if PVI was > 15% or PPV was > 13% for at least five minutes. The primary outcome was to determine if hospital LOS, which was defined as the number of days from surgery up to the day the surgeon authorized hospital discharge, was equivalent between the two groups. RESULTS: A total of 76 patients were included and they were randomized into two groups of 38 patients. Baseline characteristics were similar in both groups. Both PVI and PPV guided GDFT strategies were equivalent for the primary outcome of LOS (median [interquartile range]) (days) 2.5 [2.0-3.3] vs. 3.0 [2.0-5.0], p = 0.230, respectively. Fluids infused, postoperative complications, and all other outcomes were not different between groups. CONCLUSION: In patients undergoing low-to-moderate risk abdominal surgery, PVI seems to guide GDFT similarly to PPV in regards to hospital LOS, amount of fluid, and incidence of postoperative complications. However, in low-risk patients undergoing these surgical procedures optimizing stroke volume may have limited impact on outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02908256 , September 2016, retrospectively registered.

Cell-Free DNA Analysis in Maternal Blood: Differences in Estimates between Laboratories with Different Methodologies Using a Propensity Score Approach.

OBJECTIVES: To evaluate the failure rate and performance of cell-free DNA (cfDNA) testing, mainly in terms of detection rates for trisomy 21, performed by 2 laboratories using different analytical methods. METHODS: cfDNA testing was performed on 2,870 pregnancies with the HarmonyTM Prenatal Test using the targeted digital analysis of selected regions (DANSR) method, and on 2,635 pregnancies with the "Cerba test" using the genome-wide massively parallel sequencing (GW-MPS) method, with available outcomes. Propensity score analysis was used to match patients between the 2 groups. A comparison of the detection rates for trisomy 21 between the 2 laboratories was made. RESULTS: In all, 2,811 patients in the Harmony group and 2,530 patients in the Cerba group had no trisomy 21, 18, or 13. Postmatched comparisons of the patient characteristics indicated a higher no-result rate in the Harmony group (1.30%) than in the Cerba group (0.75%; p = 0.039). All 41 cases of trisomy 21 in the Harmony group and 93 cases in the Cerba group were detected. CONCLUSIONS: Both methods of cfDNA testing showed low no-result rates and a comparable performance in detecting trisomy 21; yet GW-MPS had a slightly lower no-result rate than the DANSR method.

The role of the vitreous body in effective IOL positioning.

PURPOSE: To compare the effective lens position (ELP) after phaco surgery alone and after combined phacovitrectomy surgery. METHODS: Twenty patients who were scheduled for elective surgery in both eyes were included. In one eye, phacovitrectomy surgery was performed (without any tamponade), and in the fellow eye, only phaco surgery was performed using the same IOL type. Pre- and postoperative biometric measurements were performed using laser interference biometry. The postoperative anterior chamber depth (ACD) was measured to determine the ELP. The primary outcome measure was the difference in the postoperative ACD between both eyes. RESULTS: The postoperative ACD following phacovitrectomy showed a statistically significant increase compared with that following phaco surgery alone, indicating a more posterior position of the IOL. CONCLUSIONS: An adjusted ELP parameter to optimize IOL calculation may be useful in eyes undergoing combined phacovitrectomy sugergy.

Continuous Ropivacaine Subfascial Wound Infusion Compared With Intrathecal Morphine for Postcesarean Analgesia: A Prospective, Randomized Controlled, Double-Blind Study.

BACKGROUND: After cesarean delivery, postoperative pain management allows early rehabilitation and helps prevent postpartum depression and chronic pain. Our present prospective, randomized controlled, double-blind study assessed the duration and effect of intrathecal analgesia and continuous ropivacaine wound infiltration versus a control group after cesarean delivery. The primary outcome was analgesia duration, defined as time to first morphine request. Secondary outcomes were cumulative postoperative morphine consumption, number of patients who did not require IV morphine, incidence of adverse effects, and time to first ambulation. METHODS: A total of 192 full-term parturients undergoing elective cesarean delivery were randomly allocated into 3 groups (control, morphine, and catheter). All patients received spinal anesthesia with 10 mg bupivacaine 0.5% hyperbaric bupivacaine (2 mL) + 5 µg of sufentanil (1 mL) and a multiholed catheter inserted into the wound. In the control group, NaCl 0.9% was administered intrathecally (0.1 mL) and through the catheter. The morphine group received 100 µg morphine (0.1 mL) intrathecally and NaCl 0.9% infused through the wound catheter. The catheter group received 0.1 mL NaCl 0.9% intrathecally and ropivacaine 0.2% infused in the catheter. Each patient received a 15-mL bolus of the dedicated solution through the catheter, which was connected to an elastomeric pump infusor delivering the same solution at a rate of 10 mL/h for 30 hours. All patients also received multimodal analgesia including acetaminophen and diclofenac. Analgesia duration was defined as the time from spinal injection (T0) to first IV morphine requirement (T1) administered via a patient-controlled IV analgesia pump. Statistical data analyses included use of the Kruskal-Wallis rank-sum test followed by the post hoc Tukey test and χ test. RESULTS: The duration of postoperative analgesia was increased with intrathecal morphine (380 minutes; 215-1527) and ropivacaine wound infusion (351 minutes; 227-594) compared with the control (247 minutes; 182-338) with effect sizes of 0.171 (0.043-0.293) for morphine versus control and 0.164 (0.052-0.271) for catheter versus control. There was no difference between the morphine group and catheter group (effect size, 0.007; -0.118 to 0.132). Cumulative postoperative morphine consumption was also significantly lower in the morphine group and catheter group compared with the control group. The incidence of adverse effects did not differ between groups. CONCLUSIONS: After elective cesarean delivery, 100 µg intrathecal morphine and ropivacaine wound infusion both increased the duration and effect of postcesarean analgesia without increased incidence of side effects.

Impact of On-Bypass Red Blood Cell Transfusion on Severe Postoperative Morbidity or Mortality in Children.

BACKGROUND: Children undergoing cardiac surgery are frequently exposed to red blood cell (RBC) transfusions mainly in the case of hemorrhage or low oxygen transport. However, in this population, RBCs are sometimes added to the cardiopulmonary bypass (CPB) priming solution to maintain a predefined hematocrit on bypass. In this study, we investigated the impact of RBCs added to the CPB on severe postoperative morbidity or mortality. METHODS: This retrospective cohort study was conducted between 2006 and 2012 in a tertiary care level, children's hospital. Children receiving red cells only to prime the CPB (CPB transfusion) were compared with those receiving no RBCs during their entire hospital stay. The primary outcome was severe postoperative morbidity or mortality. Studied secondary outcomes were neurologic deficit, infection, length of mechanical ventilation, pediatric intensive care unit and hospital length of stay, and mortality. Both groups were compared with propensity score analysis where patients were matched via a genetic matching algorithm. In all analyses, applying a Bonferroni correction, a P value <.05/8 = .00625, was considered statistically significant. RESULTS: Among the 854 patients retained for this study, 439 (51.4%) received no RBC transfusion during their entire hospital stay and 415 (49.6%) received a CPB transfusion. Thirty-five (8.0%) patients in the no-transfusion group and 110 (26.5%) patients in the CPB transfusion group developed severe postoperative morbidity or died. This difference was statistically significant using univariate analysis (P < .001). Propensity score analysis showed that 79 (19.55%) patients developed severe postoperative morbidity or died in the no-transfusion group compared with 103 (25.50%) patients in the CPB transfusion group (P = .043). The relative risk and its Bonferroni-corrected confidence interval was 0.77 (0.53-1.10). All secondary outcomes were not significantly different between both groups, except the number of patients who developed infections (P < .001). CONCLUSIONS: In the condition of our study, adding RBCs to the CPB priming to maintain a predefined hematocrit does not seem to impact markedly severe postoperative morbidity or mortality in children undergoing cardiac surgery. Only the risk of infection was increased in the CPB transfusion group. Further studies are warranted to better understand the complex interaction among severity of illness, anemia, RBCs transfusion, and outcome in children undergoing cardiac surgery.

Efficacy and safety evaluation of Monoblue Dual View and Monoblue ILM View vital stains during vitrectomy surgery.

PURPOSE: To compare the staining properties of Monoblue inner limiting membrane (ILM) View and Monoblue DUAL View (study products) vital stains during vitrectomy surgery to those of ILM Blue or Membrane Blue Dual (control products). METHODS: In this study, 105 patients were included in the Ophthalmic Clinic of the University Hospitals Leuven from September 2021 to April 2022. For prospective data collection in this study, patients were randomized between a control group (ILM Blue or Membrane Blue Dual, manufactured and commercialized by DORC®) and a study group (Monoblue ILM View or Monoblue DUAL View, manufactured and commercialized by Arcadophta®-BVI®). For retrospective data collection, patients were divided into similar surgery groups. Efficacy was analyzed using a binary subjective evaluation of the visualization of stained membranes during vitrectomy. The rate and severity of potential adverse events related to the study products were tracked, allowing both treatment groups to be compared with the corresponding control groups (ILM Blue and Membrane Blue Dual). RESULTS: Based on the results and findings, none of the comparisons (primary outcomes) were statistically significant, showing similar efficacy of the dyes used. The study products were found to be safe in this study since no serious adverse events were reported. CONCLUSIONS: The present findings indicate that the Monoblue ILM View and Monoblue DUAL View dyes can safely be used during vitrectomy to stain the ILM and/or epiretinal membrane (ERM) when removal is needed.

Effect of opioid-free versus opioid-based strategies during multimodal anaesthesia on postoperative morphine consumption after bariatric surgery: a randomised double-blind clinical trial.

Background: The efficacy and safety of opioid-free anaesthesia during bariatric surgery remain debated, particularly when administering multimodal analgesia. As multimodal analgesia has become the standard of care in many centres, we aimed to determine if such a strategy coupled with either dexmedetomidine (opioid-free anaesthesia) or remifentanil with a morphine transition (opioid-based anaesthesia), would reduce postoperative morphine requirements and opioid-related adverse events. Methods: In this prospective double-blind study, 172 class III obese patients having laparoscopic gastric bypass surgery were randomly allocated to receive either sevoflurane-dexmedetomidine anaesthesia with a continuous infusion of lidocaine and ketamine (opioid-free group) or sevoflurane-remifentanil anaesthesia with a morphine transition (opioid-based group). Both groups received at anaesthesia induction a bolus of magnesium, lidocaine, ketamine, paracetamol, diclofenac, and dexamethasone. The primary outcome was 24-h postoperative morphine consumption. Secondary outcomes included postoperative quality of recovery (QoR40), incidence of hypoxaemia, bradycardia, and postoperative nausea and vomiting (PONV). Results: Eighty-six patients were recruited in each group (predominantly women, 70% had obstructive sleep apnoea). There was no significant difference in postoperative morphine consumption (median [inter-quartile range]: 16 [13-26] vs 15 [10-24] mg, P=0.183). The QoR40 up to postoperative day 30 did not differ between groups, but PONV was less frequent in the opioid-free group (37% vs 59%, P=0.005). Hypoxaemia and bradycardia were not different between groups. Conclusions: During bariatric surgery, a multimodal opioid-free anaesthesia technique did not decrease postoperative morphine consumption when compared with a multimodal opioid-based strategy. Quality of recovery did not differ between groups although the incidence of PONV was less in the opioid-free group. Clinical trial registration: NCT05004519.

A Monte Carlo simulation study comparing the up and down, biased-coin up and down and continual reassessment methods used to estimate an effective dose (ED95 or ED90) in anaesthesiology research.

Background: Dose-finding studies in anaesthesiology aim to target the effective dose (ED) of an anaesthetic agent in a specific population. The common dose-finding designs used are the up and down method (UDM), the biased-coin up and down (BCD), and the continual reassessment method (CRM). Although the advantages of CRM over the UDM and BCD methods have been described in the statistical literature in terms of precision and direct estimation of ED, CRM may also offer attractive properties from an ethical point of view. Methods: Based on Monte Carlo simulations, this article aims to compare the three methods with regard to 1) their ability to find as close an estimate as possible for the ED95 or ED90 and 2) the total number of patients needed to treat and the number of failures. Results: In contrast to BCD and UDM, CRM does find an estimate for ED95 and ED90. UDM underestimates both ED95 and ED90. BCD is close to the targeted EDs when the starting dose does not exceed the ED of interest, otherwise it overestimates it. CRM with cohorts of two patients is closest to the ED of interest independently of the starting doses. CRM requires between 20 and 50 observations, UDM should include 90 patients, and BCD 100 or 60 observations. Lastly, CRM is associated with fewer failures, compared with BCD and UDM. Conclusions: Based on Monte Carlo simulations, our work suggests that the UDM is not an adequate dose-finding method because it underestimates the ED of interest. Compared with BCD, CRM offers the advantages of being more efficient, requires fewer patients to be included, and is associated with fewer failures.