scholarly journals Serum Biomarkers in Postoperative Delirium after Esophagectomy

2020 ◽  
Vol 3 ◽  
Author(s):  
Azhar Dalal ◽  
Sikandar Khan ◽  
Heidi Lindroth ◽  
Babar Khan
Keyword(s):  
Calcium Binding ◽  
Postoperative Delirium ◽  
Rating Scale ◽  
Controlled Trial ◽  
Assessment Method ◽  
Serum Biomarkers ◽  
University Hospital ◽  
Inflammatory Biomarkers ◽  
Double Blind ◽  
Necrosis Factor Alpha

Background: The pathophysiology of postoperative delirium in patients undergoing esophagectomy is not well understood but has been hypothesized to involve neuroinflammation. Inflammatory biomarkers may therefore be associated with delirium incidence and severity. We conducted this study to measure the association between serum inflammatory biomarkers and postoperative delirium and delirium severity.     Methods: Blood samples were obtained from patients enrolled in a randomized double-blind placebo-controlled trial undergoing elective esophagectomy at Indiana University Health University Hospital. S100 calcium-binding protein B, C-Reactive Protein (CRP), interleukins 8, 10, tumor necrosis factor-alpha, and insulin like growth factor 1 (IGF1) were analyzed at preoperative, and postoperative days 1 and 3 timepoints. Delirium status and severity were assessed using the Confusion Assessment Method for Intensive Care Unit and Delirium Rating Scale (DRS-R-98), respectively.     Results: Samples from 71 patients were included. Higher median CRP values were associated with delirium incidence at post-operative day 1 (no delirium: 22.7 IQR:2.2, 42.7; delirium: 35.4 IQR:25.0, 50.0, p=0.031) but not at post-operative day 3. Median CRP S100B serum values were correlated with mean delirium severity (-0.289, p=0.020). IGF-1 serum values were associated with delirium severity on post-operative day 1 (0.270, p=0.040).     Conclusion: Postoperative delirium incidence was associated with higher median CRP values at POD1. The findings of this study provide evidence for the early measurement of post-operative serum biomarkers to ascertain likely incidence and severity of delirium.  

scholarly journals Melatonin for prevention of postoperative delirium after lower limb fracture surgery in elderly patients (DELIRLESS): study protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053908
Author(s):  
Stéphanie Sigaut ◽  
Camille Couffignal ◽  
Marina Esposito-Farèse ◽  
Vincent Degos ◽  
Serge Molliex ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Lower Limb ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Functional Decline ◽  
Assessment Method ◽  
Phase Iii ◽  
Double Blind ◽  
Prolonged Length ◽  
Surgery In Elderly

IntroductionPostoperative delirium (POD) is one of the most frequent complication after surgery in elderly patients, and is associated with increased morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs. Perioperative inflammatory stress is a key element in POD genesis. Melatonin exhibits antioxidative and immune-modulatory proprieties that are promising concerning delirium prevention, but in perioperative context literature are scarce and conflicting. We hypothesise that perioperative melatonin can reduce the incidence of POD.Methods and analysisThe DELIRLESS trial is a prospective, national multicentric, phase III, superiority, comparative randomised (1:1) double-blind clinical trial. Among patients aged 70 or older, hospitalised and scheduled for surgery of a severe fracture of a lower limb, 718 will be randomly allocated to receive either melatonin 4 mg per os or placebo, every night from anaesthesiologist preoperative consultation and up to 5 days after surgery. The primary outcome is POD incidence measured by either the French validated translation of the Confusion Assessment Method (CAM) score for patients hospitalised in surgery, or CAM-ICU score for patients hospitalised in ICU (Intensive Care Unit). Daily delirium assessment will take place during 10 days after surgery, or until the end of hospital stay if it is shorter. POD cumulative incidence function will be compared at day 10 between the two randomised arms in a competing risks framework, using the Fine and Grey model with death as a competing risk of delirium.Ethics and disseminationThe DELIRLESS trial has been approved by an independent ethics committee the Comité de Protection des Personnes (CPP) Sud-Est (ref CPP2020-18-99 2019-003210-14) for all study centres. Participant recruitment begins in December 2020. Results will be published in international peer-reviewed medical journals.Trial registration numberNCT04335968, first posted 7 April 2020.Protocol version identifierN°3–0, 3 May 2021.

scholarly journals Comparison of postoperative delirium in patients anesthetized with isoflurane versus desflurane during spinal surgery: A prospective randomized controlled trial

2019 ◽  
Vol 10 ◽  
pp. 226
Author(s):  
Steve Joys ◽  
Tanvir Samra ◽  
Vishal Kumar ◽  
Manju Mohanty ◽  
Harsimrat B. S. Sodhi ◽  
...  
Keyword(s):  
Spine Surgery ◽  
Spinal Surgery ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Confusion Assessment Method ◽  
Assessment Method ◽  
Double Blind ◽  
Anesthetic Agents ◽  
Number Of Patients ◽  
Severity Scores

Background: Following spine surgery, different types of inhalational anesthetic agents can result in postoperative delirium (POD) that can increase perioperative/postoperative morbidity. Here, we compared the incidence of POD in adults undergoing spine surgery anesthetized with isoflurane versus desflurane. Methods: A prospective randomized double-blind clinical trial for patients undergoing spinal surgery was performed in 60 adults (aged 18–65 years); they were randomized to receive isoflurane or desflurane. On postoperative days 1 and 3, the diagnosis and severity of POD utilized 3D-Confusion Assessment Method (CAM) and CAM-severity delirium severity scores to assess patients’ status. Multiple other variables which may have influenced the frequency/severity of POD were also studied. Results: For the two groups, the incidence of POD utilizing isoflurane and desflurane was similar on postoperative days 1 (10% vs. 13.3%, P > 0.05) and 3 (6.6% vs. 0%, P > 0.05). The severity scores of POD for both anesthetic agents were also similar on postoperative days 1 (1.5 vs. 1) and 3 (0.5 vs. 0.5). In addition, there was no significant association of POD with other perioperative factors. Conclusion: A significant number of patients undergoing spine surgery experience POD. However, the incidence and severity of POD remained similar when utilizing either isoflurane or desflurane.

The effect of pre-operative methylprednisolone on postoperative delirium in elderly patients undergoing gastrointestinal surgery: a randomized, double-blind, placebo-controlled trial

2021 ◽  
Author(s):  
Xiao-bing Xiang ◽  
Hao Chen ◽  
Ying-li Wu ◽  
Ke Wang ◽  
Xiang Yue ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Heparan Sulfate ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Gastrointestinal Surgery ◽  
Assessment Method ◽  
Endothelial Glycocalyx ◽  
Double Blind ◽  
Tnf Α ◽  
Circulating Markers

Abstract Background Pre-operative administration of methylprednisolone reduced circulating markers of endothelial activation. This randomized, double-blind was to evaluate whether a single pre-operative dose of methylprednisolone reduced the rate of postoperative delirium (POD) in older patients undergoing gastrointestinal surgery, and its association with the shedding of endothelial glycocalyx markers. Methods 168 patients, aged 65–80 years and scheduled for laparoscopic gastrointestinal surgery, were randomized to 2 mg·kg -1 methylprednisolone (Group M, n = 84); or equivalent dose of placebo (Group C, n = 84). The primary outcome was the incidence of delirium during the first 5 days after surgery, assessed by the confusion assessment method (CAM). POD severity was rated daily using CAM-Severity (CAM-S). Level of syndecan-1, heparan sulfate, tumor necrosis factor-α(TNF-α), and brain-derived neurotrophic factor (BDNF) were measured at baseline, 1-day, and 3-day after surgery. Results Compared with placebo, methylprednisolone greatly reduced the incidence of delirium at 72 h following surgery [9(10.7%) versus 20(23.8%), P =0.03, OR=2.22(95%CI 1.05-4.59)]. No between-group difference was found in the cumulative CAM-S score (P=0.14). The levels of heparan sulfate, syndecan-1, and TNF-α in Group M were lower than that in Group C (P <0.05 and P <0.01), while the level of BDNF in Group M was higher than that in Group C (P <0.01). Conclusions Pre-operative administration of methylprednisolone does not reduce the severity of POD, but may reduce the incidence of delirium after gastrointestinal surgery in elderly patients, which may be related to a reduction in circulating markers of endothelial degradation, followed by the increase of BNDF level.

scholarly journals Effects of Melatonin on Postoperative Delirium After PCI in Elderly Patients: A Randomized, Single-Center, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 24 (5) ◽  
pp. E893-E897
Author(s):  
Yicheng Shi
Keyword(s):  
Placebo Group ◽  
Elderly Patients ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Assessment Method ◽  
Double Blind ◽  
Significant Difference ◽  
Hospitalization Costs ◽  
To Receive

Background: Experimental evidence has indicated the benefits of melatonin (Mel) for the treatment of delirium. Clinical trials had no definite conclusions concerning Mel on delirium after percutaneous transluminal coronary intervention (PCI) in elderly patients. The present study explored whether acute Mel treatment could reduce the incidence of delirium. Methods: This trial enrolled patients over the age of 60, who were admitted to intensive care units (ICUs) after PCI. A computer-generated randomization sequence (in a 1:1 ratio) was used to randomly assign patients to receive Mel (3 mg/day) or placebo once daily for up to 7 days. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method (CAM) during the first 7 postoperative days. Analyses were performed using intention-to-treat and safety populations. Results: A total of 297 patients randomly were assigned to receive either placebo (N = 149) or Mel (N = 148). The incidence of postoperative delirium was significantly lower in the Mel group than in the placebo group (27.0% vs. 39.6%, respectively, P = 0.02). There was no significant difference between 30-day all-cause mortality (12.2% vs. 14.1%, P = 0.62) and drug reactions (0 vs. 2.0%, P = 0.25). The length of stay and hospitalization costs in the Mel group were significantly decreased compared with those in the placebo group (P > 0.05). Conclusion: The current study suggests that Mel is safe and effective in the treatment of delirium after PCI. Further investigation is necessary to fully understand the potential usefulness of Mel in older patients via larger randomized, multicenter, double-blind, and placebo-controlled trials.

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

scholarly journals Acute Effects of Triiodothyronine on Endothelial Function in Human Subjects

2007 ◽  
Vol 92 (1) ◽  
pp. 250-254 ◽  
Author(s):  
Raffaele Napoli ◽  
Vincenzo Guardasole ◽  
Valentina Angelini ◽  
Emanuela Zarra ◽  
Daniela Terracciano ◽  
...  
Keyword(s):  
Endothelial Function ◽  
Dose Response ◽  
Vascular Reactivity ◽  
Controlled Trial ◽  
University Hospital ◽  
Acute Effects ◽  
Response Curves ◽  
Double Blind ◽  
Low T3 ◽  
Dose Response Curves

Abstract Context: Thyroid hormone regulates several cardiovascular functions, and low T3 levels are frequently associated with cardiovascular diseases. Whether T3 exerts any acute and direct effect on endothelial function in humans is unknown. Objective: Our objective was to clarify whether acute changes in serum T3 concentration affect endothelial function. Design, Setting, and Subjects: Ten healthy subjects (age, 24 ± 1 yr) participated in a double-blind, placebo-controlled trial at a university hospital. Interventions: T3 (or placebo) was infused for 7 h into the brachial artery to raise local T3 to levels observed in moderate hyperthyroidism. Vascular reactivity was tested by intraarterial infusion of vasoactive agents. Main Outcome Measures: We assessed changes in forearm blood flow (FBF) measured by plethysmography. Results: FBF response to the endothelium-dependent vasodilator acetylcholine was enhanced by T3 (P = 0.002 for the interaction between T3 and acetylcholine). The slopes of the dose-response curves were 0.41 ± 0.06 and 0.23 ± 0.04 ml/dl·min/μg in the T3 and placebo study, respectively (P = 0.03). T3 infusion had no effect on the FBF response to sodium nitroprusside. T3 potentiated the vasoconstrictor response to norepinephrine (P = 0.006 for the interaction). Also, the slopes of the dose-response curves were affected by T3 (1.95 ± 0.77 and 3.83 ± 0.35 ml/dl·min/mg in the placebo and T3 study, respectively; P &lt; 0.05). The increase in basal FBF induced by T3 was inhibited by NG-monomethyl-l-arginine. Conclusions: T3 exerts direct and acute effects on the resistance vessels by enhancing endothelial function and norepinephrine-induced vasoconstriction. The data may help clarify the vascular impact of the low T3 syndrome and point to potential therapeutic strategies.

Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: A double-blind placebo-controlled trial followed by an open-label extension

2013 ◽  
Vol 28 (6) ◽  
pp. 386-391 ◽  
Author(s):  
I. Manor ◽  
A. Magen ◽  
D. Keidar ◽  
S. Rosen ◽  
H. Tasker ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Rating Scale ◽  
Controlled Trial ◽  
Study Groups ◽  
Open Label ◽  
Double Blind ◽  
Blood Biochemical ◽  
Study Results ◽  
Open Label Extension ◽  
Safety Parameters

AbstractObjective:To evaluate the safety of phosphatidylserine (PS) enriched with omega3 fatty acids, mainly eicosapentaenoic (PS-Omega3) in children with attention-deficit hyperactivity disorder (ADHD).Methods:Two hundred children diagnosed with ADHD were randomised to receive either PS-Omega3 (300 mg PS-Omega3/day) or placebo for 15 weeks. One hundred and fifty children continued into an open-label extension for an additional 15 weeks in which they all consumed PS-Omega3 (150 mg PS-Omega3/day). Standard blood biochemical and haematological safety parameters, blood pressure, heart rate, weight and height were evaluated. Adverse events and the Side Effect Rating Scale were also assessed.Results:One hundred and sixty-two participants completed the double-blind phase. No significant differences were noted between the two study groups in any of the safety parameters evaluated. One hundred and forty participants completed the open-label phase. At the end of this phase, no significant changes from baseline were observed in any of the studied parameters among participants who consumed PS-Omega3 for 30 weeks.Conclusions:Study results demonstrate that consumption of PS-Omega3 by children with ADHD, as indicated in a 30-week evaluation period, is safe and well tolerated, without any negative effect on body weight or growth.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Nalbuphine ER Tablets for Uremic Pruritus

2017 ◽  
Vol 46 (6) ◽  
pp. 450-458 ◽  
Author(s):  
Vandana S. Mathur ◽  
Jayant Kumar ◽  
Paul W. Crawford ◽  
Howard Hait ◽  
Thomas Sciascia ◽  
...  
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Hemodialysis Patients ◽  
Opioid Antagonist ◽  
Opioid Agonist ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Uremic Pruritus ◽  
The Mean

Background: Pruritus is a distressing hallmark of the uremic condition, affecting approximately 60% of hemodialysis patients. Abnormal endogenous opioid ligand activity at μ and κ-opioid receptors has been postulated as a mechanism in uremic pruritus. Nalbuphine is a μ-opioid antagonist and κ-opioid agonist. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 373 hemodialysis patients with moderate or severe uremic pruritus were randomized in a 1: 1:1 ratio to nalbuphine extended-release tablets 120 mg (NAL 120), 60 mg (NAL 60), or placebo and treated for 8 weeks. Three hundred seventy-one were analyzed for efficacy. The primary endpoint was the change from baseline to treatment weeks 7 and 8 in itching intensity on a Numerical Rating Scale (NRS, 0 [no itching]; 10 [worst possible itching]) using an intent-to-treat approach. The aim was to evaluate the safety and antipruritic efficacy of NAL. Results: The mean duration of itching was 3.2 years. From a baseline NRS of 6.9 (1.5), the mean NRS declined by 3.5 (2.4) and by 2.8 (2.2) in NAL 120 mg and the placebo groups, respectively (p = 0.017). There was no evidence of tolerance. A trend for less sleep disruption due to itching (p = 0.062, NAL 120 vs. placebo) was also observed. There were no significant differences between NAL 60 vs. placebo. Serious adverse events occurred in 6.7, 12.7, and 15.4% in the NAL 120, NAL 60, and placebo groups respectively. Conclusions: In this largest-to-date randomized controlled trial in uremic pruritus, NAL 120 durably and significantly reduced the itching intensity among hemodialysis patients.

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