scholarly journals Effects of perioperative rosuvastatin on postoperative delirium in elderly patients: A randomized, double-blind, and placebo-controlled trial

2021 ◽  
Vol 9 (21) ◽  
pp. 5909-5920
Author(s):  
Xiao-Qin Xu ◽  
Jing-Zhi Luo ◽  
Xiao-Yu Li ◽  
Hai-Qin Tang ◽  
Wei-Hong Lu
Keyword(s):  
Elderly Patients ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Double Blind

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 Effects of dexmedetomidine on postoperative delirium and expression of IL-1, IL-6, and TNF-α in elderly patients after hip fracture operation

2020 ◽  
Author(s):  
Wenchao Zhang ◽  
Tianlong Wang ◽  
Geng Wang ◽  
Minghui Yang ◽  
Yan Zhou ◽  
...  
Keyword(s):  
Hip Fracture ◽  
Elderly Patients ◽  
Postoperative Delirium ◽  
Early Stage ◽  
Surgical Complication ◽  
Controlled Trial ◽  
Venous Blood ◽  
Inflammatory Factors ◽  
Double Blind ◽  
Tnf Α

Abstract Background: Postoperative delirium (POD) is a common surgical complication in elderly patients. This study investigated the effects of dexmedetomidine on POD and inflammatory factors in elderly patients with hip fracture.Methods: The randomized, double-blind, controlled trial enrolled patients aged ≥65 years who underwent operation for hip fracture in the Department of Anesthesiology in Beijing JiShuiTan Hospital from October 2016 to January 2017. The patients were divided into the DEX group and the NS group and were intravenously infused with dexmedetomidine or an equal volume of normal saline, respectively. After surgery, the incidence of delirium at postoperative day 1 (T1), day 2 (T2) and day 3 (T3) were assessed using the Ramsay score and Confusion Assessment Method (CAM) delirium scale. Interleukin (IL)-1, IL-6 and tumor necrosis factor (TNF)-α concentrations in the venous blood of the two groups of patients were detected at T0 (before surgery), T1 and T3.Results: Data from 218 patients were analyzed with 110 patients in the DEX group and 108 in the NS group. Dexmedetomidine decreased POD incidence (18.2% vs. 30.6%, P=0.033). Compared to T0, all three inflammatory factors increased at T1 and then decreased at T3 and changes with time were significant (all P<0.001). IL-6 (P<0.001) and TNF-α (P=0.003) levels were lower in the DEX group, but IL-1 levels were similar. The rate of adverse events was similar in the two groups.Conclusions: Dexmedetomidine reduced the incidence of POD in elderly patients with hip fracture at an early stage, and reduced short-term IL-6 and TNF-α concentrations.

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 &lt;0.05 and P &lt;0.01), while the level of BDNF in Group M was higher than that in Group C (P &lt;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.

Using Activities of Daily Living Assessments to Measure the Effectiveness of Vitamin D Supplements in Elderly Long-Stay Patients

1987 ◽  
Vol 50 (2) ◽  
pp. 60-62 ◽  
Author(s):  
D Corless ◽  
M Ellis ◽  
E Dawson ◽  
F Fraser ◽  
S Evans ◽  
...  
Keyword(s):  
Vitamin D ◽  
Elderly Patients ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Controlled Trial ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
Low Concentrations ◽  
25 Hydroxyvitamin D ◽  
Vitamin D Supplements

Selected activities of daily living were used to measure improvement in independence of long-stay elderly patients known to have low concentrations of plasma 25-hydroxyvitamin D. This was a double-blind random controlled trial lasting between 8 and 40 weeks. No significant changes were found in either group.

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