scholarly journals A Randomised Trial: BIS-Guided Anesthesia Decreases The Incidence of Delayed Neurocognitive Recovery And Postoperative Neurocognitive Disorder But Not Postoperative Delirium

Author(s):  
Xingqu Chen ◽  
Linji Li ◽  
Li Yang ◽  
Aijiao Li ◽  
Miao Wu ◽  
...  

Abstract Background. Postoperative cognitive dysfunction (POCD) renamed of delayed neurocognitive recovery (up to 30 days) and postoperative neurocognitive disorder (up to 12 months), is a frequent complication of the neurological system associated with poor outcome. This randomised controlled trial was aimed to determine whether bispectral (BIS) monitoring has a correlation with delayed neurocognitive recovery, postoperative neurocognitive disorder, or postoperative delirium (POD). Methods.100 patients were assigned to the BIS group and 97 patients were assigned to the control group in the study. The BIS index was kept in 40-60 in the BIS group, and the depth of anesthesia in the control group was maintained according to anesthetists’ clinical experiences. The cognitive function was evaluated from the first day to the seventh day after the operation and the time of discharge, 1 month, 6th month and 1 year after the operation.Results. The incidence of delayed neurocognitive recovery (3% vs 21.6%, P<0.001, at 7th day) (1% vs 21.1%, P<0.001, at 1 month) and postoperative neurocognitive disorder (6.2% vs 21.3%, P=0.002, at 6th month) (4.4% vs 16.3% ,P=0.009, at 1 year) are lower in BIS group. While there is no significant difference between two group in POD (12% vs 19.6%, P=0.144). The average value of intraoperative BIS were lower in BIS group (43.75 vs 50.69,P<0.001). The postoperative hospitalisation time (9.99 vs 12.41, P<0.001) and the mortality (5.4% vs 14.4%, P=0.042) was significantly decreased while the satisfaction is higher in BIS group (39% vs 24.7%, P=0.009). Conclusions. Using BIS can decrease delayed neurocognitive recovery and postoperative neurocognitive disorder, while it is not associated with POD. BIS-monitoring can validly lessen the postoperative hospitalisation and mortality, and increase the satisfaction of patients.Clinical trial registration. Chinese Clinical Trial Registry, ChiCTR2000032463.http://www.chictr.org.cn/showproj.aspx?proj=33065

2021 ◽  
Author(s):  
Xingqu Chen ◽  
Linji Li ◽  
Li Yang ◽  
Aijiao Li ◽  
Miao Wu ◽  
...  

Abstract Background. Postoperative cognitive dysfunction (POCD) renamed of delayed neurocognitive recovery (up to 30 days) and postoperative neurocognitive disorder (up to 12 months), is a frequent complication of the neurological system associated with poor outcome. This randomised controlled trial was aimed to determine whether bispectral (BIS) monitoring has a correlation with delayed neurocognitive recovery, postoperative neurocognitive disorder, or postoperative delirium (POD).Methods.100 patients were assigned to the BIS group and 97 patients were assigned to the control group in the study. The BIS index was kept in 40-60 in the BIS group, and the depth of anesthesia in the control group was maintained according to anesthetists’ clinical experiences. The cognitive function was evaluated from the first day to the seventh day after the operation and the time of discharge, 1 month, 6th month and 1 year after the operation.Results. The incidence of delayed neurocognitive recovery (3% vs 21.6%, P<0.001, at 7th day) (1% vs 21.1%, P<0.001, at 1 month) and postoperative neurocognitive disorder (6.2% vs 21.3%, P=0.002, at 6th month) (4.4% vs 16.3% ,P=0.009, at 1 year) are lower in BIS group. While there is no significant difference between two group in POD (12% vs 19.6%, P=0.144). The average value of intraoperative BIS were lower in BIS group (43.75 vs 50.69,P<0.001). The postoperative hospitalisation time (9.99 vs 12.41, P<0.001) and the mortality (5.4% vs 14.4%, P=0.042) was significantly decreased while the satisfaction is higher in BIS group (39% vs 24.7%, P=0.009). Conclusions. Using BIS can decrease delayed neurocognitive recovery and postoperative neurocognitive disorder, while it is not associated with POD. BIS-monitoring can validly lessen the postoperative hospitalisation and mortality, and increase the satisfaction of patients.Clinical trial registration. Chinese Clinical Trial Registry, ChiCTR2000032463. http://www.chictr.org.cn/showproj.aspx?proj=33065


2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Xiqian Yang ◽  
Hesong Xiao ◽  
Yi Zeng ◽  
Liangliang Huang ◽  
Ke Ji ◽  
...  

Study Objectives. To study the relationship between perimenopausal insomnia (PI) and intestinal flora and the potential mechanism of Tianwang Buxin granules (TWBXG) in exerting its clinical efficacy. Methods. The subjects included 13 PI patients from the Hubei Provincial Hospital of TCM, Hubei University of TCM, and Wuhan Traditional Chinese Medicine Hospital, and the corresponding noninsomniac spouses of the patients were selected as controls. TWBXG was continuously administered for 4 weeks. The feces of PI patients and their noninsomniac spouses before and after treatment with TWBXG were collected. The intestinal flora composition of each group was detected by metagenomic sequencing, and the efficacy of TWBXG was evaluated by the PSQI scale. Results. Compared with the control group, the model group showed an increase in the abundance of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, and Blautia obeum, while those of Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii were decreased. Compared with pretreatment, the PSQI score was significantly reduced ( P < 0.05 ), the abundance of Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii increased, and that of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, and Blautia obeum decreased after treatment. However, there was still a certain gap in the abundance of related flora in the treatment group compared with the control. Conclusion. PI is associated with disturbances in the intestinal flora and is mainly related to the disorders of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, Blautia obeum, Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii. TWBXG can effectively treat PI, and its effect may be achieved by regulating the disordered intestinal flora. Clinical Trials. The study was registered in the Chinese clinical trial registry and approved by the World Health Organization clinical trial registration platform (Effects of the modified Tianwang Buxin granule and modified Tianwang Buxin decoction pieces on insomnia: a randomized, controlled trial, ChiCTR-IPR-17011549).


2020 ◽  
Author(s):  
Na He ◽  
Haixia Shi ◽  
Yajuan Hu ◽  
Alberto Uribe ◽  
Xinhua Mu ◽  
...  

Abstract Background: Postoperative cognitive dysfunction (POCD) is the decline in cognitive ability that occurs between one week and one year following surgery. POCD has been reported to occur in 5% to 26% of elderly surgical patients and its incidence varies with demographic, clinical, and surgical variables. Previous studies have shown that dexmedetomindine (DEX), a highly selective α2 adrenergic receptor agonist, has many effects that include opioid-sparing properties, decreased required anesthetic medication, and neuroprotection in animal models. Ultimately, DEX may benefit cognitive ability in the postoperative period. Therefore, we hypothesized that intraoperative infusion of DEX would reduce early POCD and interleukin-6 (IL-6) levels in elderly surgical patients compared to placebo. Methods: This randomized, double-blind, controlled trial enrolled 96 elderly patients that underwent video-assisted thoracoscopic lobectomy (VATL) between May 2017 and April 2018. The enrolled subjects were randomly assigned in a 1:1 ratio to receive intravenous dexmedetomidine (DEX Group) or placebo (0.9% normal saline, Saline Group) as a continuous infusion at a rate of 0.5μg/kg/hr starting at anesthesia induction until incision closure. All subjects received total intravenous anesthesia (TIVA) during surgery and patient controlled epidural analgesia (PCEA) following surgery. The primary outcomes were to determine the incidence of POCD and IL-6 expression at postoperative day (POD) 1, 2, and 7. The secondary outcomes were to evaluate the degree of pain on POD 1 and 2, as well as adverse events throughout the study. Results: 96 eligible subjects (48 per group) were randomized, dosed with study medication, and evaluated per protocol. There was a significant difference on POCD between the DEX and saline groups on POD 1 (6.3% vs. 20.8%, p-value <0.05) and POD 2 (4.2% vs. 16.7%, p-value <0.05). The IL-6 levels were significantly lower in the DEX group when compared with saline group during POD 1 and 2 (p-value <0.05). IL-6 returned to baseline levels on POD 7. There was no significant difference in POCD on POD7, and overall there were no significant differences in the incidence of adverse events between both groups.Conclusions: The administration of intraoperative DEX in elderly patients undergoing VATL decreased the incidence of early POCD. Clinical Trial Registry: This study was registered on Chinese Clinical Trial Registry with the ID ChiCTR-IPR-17010958.


2020 ◽  
Author(s):  
Beibei Du ◽  
Daoyuan Si ◽  
Bo Yang ◽  
Guohui Liu ◽  
Qian Zhang ◽  
...  

Abstract Introduction: Cardiac injury occurs in 7-22% of patient hospitalized with COVID-19 and an elevation in troponin is associated with a 4.2-fold increase in the risk of mortality. Preliminary data showed ACEi/ARB usage might not increase mortaily in COVID-19 patients. However, it is unknown if cardiac injury in patients with severe COVID-19 can be modulated by ACEi/ARB usage during evolution of the cardiac injury.Methods: In 154 COVID-19 patients with cardiac injury, the effect of ACEi/ARB treatment (17 patients) was compared with 137 patients without ACEi/ARB treatment. Cardiac injury was indicated by cTnI level.Results: In ACEi/ARB treatment group and no ACEi/ARB treatment group, peak cTnI level did not show significant difference (150.5 pg/ml [31.75-1179], vs 207 pg/ml [54.65-989.4], respectively, P = 0.21). Evolution of Cardiac injury (temporal change of cTnI at day 6, 9, 12, 15, 18, 21, 24, 27, 30, and 33) showed no statistical difference. Mortality (ACEi/ARB group vs no ACEi/ARB group; 52.9% vs 69.9%, P = 0.17), atrial arrhythmias (11.7% vs 24.4%, P = 0.36), requirement for invasive ventilatory support (29.4% vs 48.2%, P = 0.14) also showed no significant difference in two groups.Conclusions: ACEi/ARB usage during the COVID-19 was not associated with exacerbation of cardiac injury. These data should be interpreted as essentially hypothesis-generating due to small sample size.Clinical Trial Registration: This retrospective study was registered in Chinese clinical trial registry (ChiCTR 2000031301).


2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Yong Yang ◽  
Wenkang Yan ◽  
Minyi Ruan ◽  
Lan Zhang ◽  
Jinzhen Su ◽  
...  

Abstract Background Lung recruitment is a maneuver used to decrease the length of intubation in preterm neonates. This study aimed to compare the therapeutic efficacy of lung recruitment plus intubation-surfactant-extubation (INSURE) procedure and INSURE alone for the preterm neonates with respiratory distress syndrome. Methods From 2017 to 2019, 184 preterm neonates (gestational age 24–32 weeks) with respiratory distress syndrome were enrolled and randomized into the lung recruitment group receiving lung recruitment (25 cm H2O, 15 s) plus INSURE and the control group receiving INSURE only. The primary outcome was the need for mechanical ventilation (MV) within 72 h after extubation. The secondary outcomes included duration of MV, noninvasive ventilation, total oxygen therapy, hospitalization time, and complications. Results Compared to the control group, the lung recruitment group had a significantly lower proportion of preterm neonates requiring MV within 72 h after extubation (23% vs. 38%, P = 0.025) and pulmonary surfactant administration, as well as a shorter MV duration. There was no significant difference in the incidences of complications (all P > 0.05) and in-hospital mortality (2% vs. 4%, P = 0.4) between the lung recruitment group and control group. Multivariate logistic regression analysis demonstrated that the control group had a 2.17-time higher risk of requiring MV than the lung recruitment group (AOR: 2.17, 95% CI: 1.13–4.18; P = 0.021). Compared with infants with a normotensive mother, infants with a hypertensive mother have a 2.41-time higher risk of requiring MV (AOR: 2.41, 95% CI: 1.15–5.05; P = 0.020). Conclusion Lung recruitment plus INSURE can reduce the need for MV within 72 h after extubation and did not increase the incidence of complications and mortality. Trial registration Chinese Clinical Trial Registry ChiCTR1800020125, retrospectively registered on December 15, 2018.


2020 ◽  
Author(s):  
Huan Liu ◽  
Jun Jin ◽  
Qiao Chen ◽  
Zhongmin Li

Abstract BackgroundThe incidence of thyroid nodules increased significantly, but the mortality rate of thyroid cancer remained stable or even decreased. However, surgical treatment of thyroid nodules is more aggressive, including the number and scope of surgery. the purpose of our study was to evaluate whether unilateral thyroid nodules affect the malignancy risk of contralateral thyroid nodules. Methods We conducted a retrospective study on all patients with thyroid nodules in a tertiary hospital within one year. Unilateral and bilateral thyroid nodules were the control group and the experimental group, respectively. Based on the TI-RADS grades, the experimental group and the control group were divided into two subgroups. We used chi-square test or Fisher's exact test to evaluate whether there were statistical differences in the incidence and pathological types of thyroid cancer between the experimental group and the control group. Results Our study showed that there was no significant difference in malignant risk between the experimental group 1 and the control group 1, and the experimental group 2 and the control group 2 (20%vs35%, p=0.724, 63.16%vs76.32%, p=0.297, respectively). Both the a-side thyroid of the experimental group and the control group were papillary thyroid carcinoma, including micropapillary thyroid carcinoma, and there was no difference in the proportion of micropapillary thyroid carcinoma (p = 0.200, 0.620, respectively). Conclusions There is no evidence that bilateral thyroid nodules affect each other in terms of malignant risk, that is, in bilateral thyroid nodules, unilateral thyroid cancer does not change the malignant risk of contralateral thyroid nodules.This study has been registered with the Chinese Clinical Trial Registry, clinical trial registration number: ChiCTR2000038611, registration time: 2020-09-26.


2021 ◽  
Vol 11 ◽  
Author(s):  
Xu Chen ◽  
Xiaolong Zhang ◽  
Xuequan Zhu ◽  
Gang Wang

Background: Subclinical depression is a prevalent mental health problem and increases the incidence of the onset of major mood disorders, such as major depressive disorder (MDD). Psychological interventions have been proved to be effective for reducing depressive symptoms for people with subclinical depression and can prevent the onset of MDD. However, people have limited access to face-to-face psychotherapy. Internet-based psychological intervention is an alternative treatment option. The aim of the study is to evaluate the efficacy of MoodBox, an online psychological intervention program, for subclinical depression.Methods: This study is a multicenter, randomized, controlled, non-blinded superiority study with three parallel groups. A total of 435 first-year university students with subclinical depression will be recruited. Eligible participants will be randomly assigned to the MoodBox group, the online psychoeducation group, and the naturalistic observation group at a ratio of 1:1:1. The intervention period is 8 weeks, and participants will be continuously followed up for 1 year. The primary outcome of the study is the efficacy of the intervention, defined as measured by the Patient Health Questionnaire (PHQ-9).Discussion: This is the first study to innovatively develop and test an intervention to improve psychological well-being and decrease the incidence of MDD in a subclinical depression population in China. Once proven effective and acceptable, MoodBox could be potentially integrated into the routine clinical service to facilitate the management for people with subclinical depression.Clinical Trial Registration: The trial is registered with the Chinese Clinical Trial Registry on 21 July 2020 (No. ChiCTR2000034826).


2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Qianqian Lei ◽  
Hailong Zhao ◽  
...  

Abstract Background There are evidences for the efficacy of acupuncture treatment for chronic shoulder pain, however it remains unclear the best acupuncture modes for effective treatment. We compared the effect of myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The ultimate aim of the study is to select an effective therapy for patients with idiopathic frozen shoulder. Methods Randomized controlled trial will be conducted in the 3 clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patient will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of treatment period, and a 12-weeks of follow-up period. During the 3-weeks of treatment period, patients will receive 9 sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and Measurement of range of joint motion (ROM) from baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment. Discussion The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals. Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019


2019 ◽  
Vol 28 ◽  
Author(s):  
Andressa Carneiro França ◽  
Andrea Bezerra Rodrigues ◽  
Maria Isis Freire de Aguiar ◽  
Renan Alves Silva ◽  
Fernanda Macedo Cartaxo Freitas ◽  
...  

ABSTRACT Objective: to verify the effectiveness of telenursing in the control of nausea and vomiting induced by antineoplastic chemotherapy. Method: a randomized controlled trial of 61 cancer patients undergoing outpatient chemotherapy treatment, randomized into experimental group and control group. Nausea and vomiting were evaluated by the instrument Multinational Association on Supportive Care in Cancer. The telephone intervention was performed four times after chemotherapy. To verify the effects of this on the variables, the Mann-Whitney test and Student's t-test were used. Wilcoxon signed-rank test was applied to confirm the hypothesis of differences in the pre- and post-test intragroup scores. Results: the groups were homogeneous regarding sociodemographic and clinical characteristics. The experimental group showed a statistically significant reduction in the occurrence of nausea (p=0.0089), in the degree of nausea, in two moments, between 24 hours and three days, and three days and five days (p=0.007 and p=0.009, respectively), in the occurrence of vomiting (p=0.008) and in the number of vomiting episodes (p=0.020). Conclusion: telephone intervention is a potential nursing intervention to reduce nausea and vomiting associated with antineoplastic chemotherapy. Brazilian Clinical Trial Registry: RBR-6s8qm5.


2021 ◽  
Vol 12 ◽  
Author(s):  
Changling Li ◽  
Mengmeng Ma ◽  
Shuju Dong ◽  
Ye Hong ◽  
Jiajia Bao ◽  
...  

Background: We aimed to investigate the impact of statin treatment in the acute phase on the risk and severity of post-stroke pneumonia because of the uncertain effects of statins on post-stroke pneumonia.Methods: Consecutive cases of acute ischemic stroke (AIS) between January 2014 and February 2019 were retrospectively analyzed. Additionally, the association of statin treatment in the acute phase with the risk and severity of post-stroke pneumonia was estimated with logistic regression. We registered the present study in the Chinese Clinical Trial Registry (ChiCTR 2000032838).Results: Of the 1,258 enrolled patients, no significant difference was observed in post-stroke pneumonia risk between the two groups (with/without statin treatment in the acute phase) after propensity score matching (35.1 vs. 27.9%, p = 0.155). We did not find statin treatment in the acute phase to significantly increase the risk of post-stroke pneumonia both before and after matched analysis [odds ratio (OR) = 1.51, 95% confidence interval (CI) = 0.85–2.67, p = 0.157; OR = 1.57, 95% CI = 0.77–3.18, p = 0.213, respectively]. In the 271 patients with post-stroke pneumonia, no significant difference was found in its severity between two groups (19.6 vs. 19.4%, p = 0.964). No significant association was found between statin treatment and post-stroke pneumonia severity (OR = 0.95, 95% CI = 0.39–2.31, p = 0.918).Conclusions: There appeared to be no additional benefits of statin treatment in the acute phase for post-stroke pneumonia reduction among AIS patients.Clinical Trial Registration:http://www.chictr.org.cn, identifier: ChiCTR2000032838.


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