scholarly journals Comparison of bolus administration effects of lidocaine on preventing tourniquet-induced hypertension in patients undergoing general anesthesia: a randomized controlled trial

2021 ◽  
Author(s):  
Ji WooK Kim ◽  
A Ran Lee ◽  
Eun Sun Park ◽  
Min Su Yun ◽  
Sung Won Ryu ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Controlled Trial ◽  
Control Group ◽  
Double Blind Study ◽  
Bolus Administration ◽  
Double Blind ◽  
Single Bolus ◽  
Randomized Controlled ◽  
Induced Hypertension ◽  
Tourniquet Inflation

Background: This study assessed the effect of a single bolus administration of lidocaine on the prevention of tourniquet-induced hypertension (TIH) and compared the effect of lidocaine to that of ketamine in patients undergoing general anesthesia.Methods: This randomized, controlled, double-blind study included 75 patients who underwent lower limb surgery using a tourniquet. The patients were administered lidocaine (1.5 mg/kg, n = 25), ketamine (0.2 mg/kg, n = 25) or placebo (n = 25). The study drugs were administered intravenously 10 min before tourniquet inflation. Systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) were measured before tourniquet inflation, after tourniquet inflation for 60 min at 10 min intervals, and immediately after tourniquet deflation. The incidence of TIH, defined as an increase of 30% or more in SBP or DBP during tourniquet inflation, was also recorded.Results: SBP, DBP, and HR increased significantly over time in the control group compared to those in the lidocaine and ketamine groups for 60 min after tourniquet inflation (P < 0.001, P < 0.001, and P = 0.007, respectively). The incidence of TIH was significantly lower in the lidocaine (n = 4, 16%) and ketamine (n = 3, 12%) group than in the control group (n = 14, 56%) (P = 0.001). Conclusion: Single-bolus lidocaine effectively attenuated blood pressure increase due to tourniquet inflation, with an effect comparable to that of bolus ketamine.

scholarly journals Neurofeedback for tinnitus: Study protocol for a double-blind randomized controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both the sound perception and the psychological distress, in a cohort of chronic tinnitus sufferers

2019 ◽  
Author(s):  
Martin Jensen ◽  
Eva Hüttenrauch ◽  
Jennifer Schmidt ◽  
Gerhard Andersson ◽  
Mira-Lynn Chavanon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Neurofeedback Training ◽  
Double Blind ◽  
Sound Perception ◽  
Active Comparator ◽  
Randomized Controlled ◽  
Tinnitus Distress ◽  
Training Protocol

Abstract Background Tinnitus is a very common condition, which for some can have debilitating psychological consequences. Although some interventions are helpful in learning how to cope better with the tinnitus, at present there is no cure. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilizing an alpha/delta training protocol have shown promise. However, they were characterized by small sample sizes and lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate, if an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing, not only the tinnitus sound perception, but also the psychological symptoms associated with the condition. Methods The study is designed as a three-armed, single-blinded randomized controlled trial. Participants are randomly assigned to either an established neurofeedback protocol for tinnitus (alpha/delta training), another neurofeedback protocol as active comparator (beta/theta training) or diary control group. In the four-week intervention period, participants in both neurofeedback groups undergo ten sessions, whereas participants in the diary control group complete a diary bi-weekly. The primary outcomes are between group differences in tinnitus sound percept change, as measured with the Tinnitus Magnitude Index (TMI) and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), four weeks post baseline. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands. Discussion This is the first double-blind, randomized controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing the tinnitus sound percept and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator, beta/theta neurofeedback training, and in addition to control for placebo effects by inclusion of a diary control group. We hope this study contributes not only to our understanding of the neurological underpinnings of tinnitus, but also to the potentiality of neurofeedback as a therapeutic agent.

Abstract P034: The Effectiveness of 12-week Tai Chi Training on the Migraine Attack Days, Body Composition, and Blood Pressure in Chinese Women With Episodic Migraine: A Randomized Controlled Trial

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Yao Jie Xie ◽  
Stanley Sai-chuen Hui ◽  
Suzanne C. Ho ◽  
Lorna Kwai Ping Suen
Keyword(s):  
Blood Pressure ◽  
Migraine Attack ◽  
Body Fat ◽  
Tai Chi ◽  
Chinese Women ◽  
Controlled Trial ◽  
Episodic Migraine ◽  
Control Group ◽  
Randomized Controlled ◽  
The Difference

Background: Tai Chi is a body-mind exercise. It’s prophylactic efficacy on migraine attack remains largely unknown. The purpose of this study was to examine the effect of a 12-week Tai Chi training on the migraine attack days per month, body composition, and blood pressure (BP) in a sample of Chinese women with episodic migraine. Method: A two-arm randomized controlled trial was designed. Eighty-two local women aged 18 to 65 years and diagnosed with episodic migraine were randomized to the Tai Chi group or the waiting list control group. A modified 32-short form Yang-style Tai Chi training with 1 hour per day, 5 days per week for 12 weeks was adopted as intervention. An additional 12 weeks follow was conducted. The control group received a “delayed” Tai Chi training at the end of the trial. The difference in migraine days between 1 month before baseline, 3rd month (12nd week) and 6th month (24th week) after the randomization were examined. The changes in weight, body fat, and BP before and after the intervention were also analyzed. Results: Of 189 women screened, 82 eligible women completed the baseline assessment. After randomization, 9 women withdrew immediately, finally 40 in Tai Chi group and 33 in control group were involved in the analysis. On average, women in Tai Chi group had 3.6 (95% CI: -4.7 to -2.5, P<0.01) days reduction of migraine attack. Compared with control group, the difference was statistically significant (P<0.001). Tai Chi group also lost 0.6 kg of body weight and 0.6% of body fat at the 3rd month, and 10.8 mmHg systolic BP at the 6th month, respectively (all p<0.001). The between-group difference of systolic BP was -6.9 mmHg (95% CI: -11.6 mmHg to -2.1mmHg, p<0.05), whereas no significant differences were observed regarding weight and body fat at the 3rd month (all p>0.05). Among Tai Chi group, change in systolic BP was significantly correlated to the change in migraine days (P<0.05). Conclusion: The 12-week Tai Chi training significantly decreased the frequency of migraine attack and improved the systolic BP. The association between migraine attack reduction and BP improvement needs further investigations.

scholarly journals Effect of Steamed Potato Bread Intake on Glucose, Lipids, and Urinary Na+ and K+: A Randomized Controlled Trial with Adolescents

2020 ◽  
Vol 17 (6) ◽  
pp. 2096
Author(s):  
Haiquan Xu ◽  
Yanzhi Guo ◽  
Shijun Lu ◽  
Yunqian Ma ◽  
Xiuli Wang ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Systolic Blood Pressure ◽  
Total Cholesterol ◽  
Controlled Trial ◽  
Intervention Group ◽  
High Density Lipoproteins ◽  
Control Group ◽  
Randomized Controlled ◽  
Potato Bread

Although potatoes are highly nutritious, many epidemiological studies have connected their consumption with abnormal lipids, diabetes, and hypertension. Steamed potato bread has recently become one of China’s staple foods. A randomized controlled trial was designed to evaluate the effect of steamed potato bread consumption on Chinese adolescents. Four classes from a high school were randomly selected and assigned to the intervention group (two classes) or control group (two classes). The steamed wheat bread (100% raw wheat flour) and potato bread (raw wheat flour to cooked potato flour ratio of 3:7) were provided to the control group and intervention group as staple food once a school day for 8 weeks, respectively. Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg, p = 0.010), insulin (−4.35 mIU/L, p < 0.001), total cholesterol (−0.13 mmol/L, p = 0.032), and high-density lipoproteins cholesterol (−0.07 mmol/L, p = 0.010). The urinary level of Na+/K+ did not differ between the groups. In conclusion, the intake of steamed potato bread for 8 weeks resulted in positive effects on the total cholesterol and insulin profiles but a negative effect on the systolic blood pressure and high-density lipoproteins cholesterol of adolescents.

Urokinase-Containing Locking Solution in the Prevention of Dialysis Catheter Dysfunction: A Double Blind Randomized Controlled Trial

2017 ◽  
Vol 18 (5) ◽  
pp. 436-442 ◽  
Author(s):  
Florence Bonkain ◽  
Freya Van Hulle ◽  
Peter Janssens ◽  
Concetta Catalano ◽  
Mandelina Allamani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Incidence Rate ◽  
Controlled Trial ◽  
Recombinant Tissue Plasminogen Activator ◽  
Hemodialysis Patients ◽  
Control Group ◽  
Double Blind ◽  
Systemic Thrombolysis ◽  
Randomized Controlled ◽  
History Of

Introduction The prophylactic use of recombinant tissue plasminogen activator once weekly reduces the incidence rate of tunneled cuffed catheter (TCC) malfunction and bacteremia as compared to the exclusive use of heparin as locking solution. Restricting the use of prophylactic thrombolytic agents to patients with a history of thrombotic TCC malfunction could be more cost effective. We conduct a multicenter, double-blind, randomized controlled trial and test the hypothesis that weekly use of urokinase lock will reduce the incidence of thrombotic malfunction by 50% in prevalent hemodialysis patients with a history of thrombotic malfunction. Methods Patients with a history of at least two separate TCC thrombotic dysfunctions treated with urokinase lock during the 6 months preceding inclusion are recruited in eight Belgian dialysis units. Patients are randomized in two groups: the control group receiving Taurolock™-HEP500 (heparin 500 IU/mL, taurolidine, citrate 4%) after each hemodialysis session and the treatment group receiving Taurolock-U 25,000 (urokinase 25,000, taurolidine, citrate 4%) once a week and the standard Taurolock-HEP500 at the end of the two others sessions. The primary outcome is the incidence rate of TCC thrombotic dysfunction defined by the use of urokinase. The secondary outcomes are the incidence rate of TCC removal and systemic thrombolysis. For the study, both patients and healthcare staff are blinded to treatment allocation. Conclusions The present trial is the first to investigate the effect of Taurolock-U 25,000 catheter lock once a week as secondary prevention in hemodialysis patients with the highest risk of TCC-related thrombotic dysfunction. Trial Registration ClinicalTrials.gov Identifier: NCT02036255

scholarly journals Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

2016 ◽  
Vol 9 (5) ◽  
pp. 67
Author(s):  
Mansoureh Mirzadeh ◽  
Najmeh Shahini ◽  
Masoud Kashani Lotf Abadi ◽  
Maryam Tavakoli ◽  
Arash Javanbakht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Schizophrenic Patients

<p>Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients.<strong> </strong>This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14<sup>th</sup> and 28<sup>th</sup> days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2<sup>nd</sup>, 7<sup>th</sup>, 14<sup>th</sup>, 28<sup>th</sup>. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28<sup>th</sup> compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor<strong> </strong><strong>p </strong>value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05.<strong> </strong>Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.</p>

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium risk hypertension: study protocol for a randomized double-blind controlled trial

2021 ◽  
Author(s):  
xiaochen Yang ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
Hongzheng Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome ◽  
And Control

Abstract IntroductionHypertension is one of the most important risk factors for cardiovascular disease, and its treatment and control rates are still low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) may suppress ventricular hypertrophy and inflammatory responses, lower blood pressure and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension.Methods and analysisThis trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experiment group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is blood pressure, which is reduced to a threshold set out in Guiding Principles for Clinical Research of New Chinese Medicines. The secondary outcomes include the change in 24-h average systolic and diastolic blood pressure, heart rate variability, pharmacogenomic Evaluation, improvement in TCM Syndrome, serum pro-inflammatory/anti-inflammatory cytokines, etc. between the two groups. Safety in medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DiscussionWe hypothesize that patients with low-to-medium risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians.

1107Reduction of cardiovascular disease risk factors in rural, medically under-served, socioeconomically distressed, high-risk individuals: a randomized controlled trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Moser ◽  
M L Chung ◽  
F Feltner ◽  
T A Lennie ◽  
M J Biddle
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Risk Reduction ◽  
Controlled Trial ◽  
Self Care ◽  
Density Lipoprotein ◽  
Control Group ◽  
Cvd Risk Factors ◽  
Cvd Risk ◽  
Randomized Controlled

Abstract Background People in rural, socioeconomically distressed areas of the world suffer from marked cardiovascular disease (CVD) disparities. Despite the CVD disparities seen in rural, distressed areas, efforts directed toward CVD risk reduction and prevention are limited. We conducted a randomized, controlled trial to determine the effect of an individualized, culturally appropriate, self-care CVD risk reduction intervention (HeartHealth) compared to referral of patients to a primary care provider for usual care on the following CVD risk factors: tobacco use, blood pressure, lipid profile, body mass index, depressive symptoms, and physical activity levels. Methods The study protocol and intervention were developed with a community advisory board of lay community members, business owners, local government officials, church leaders, and healthcare providers. We enrolled 355 individuals living in Appalachia with two or more CVD risk factors. The intervention was delivered in person to groups of 10 or fewer individuals over 12 weeks. In the first session, participants chose their CVD risk reduction goals. HeartHealth was designed to provide participants with self-care skills targeting CVD risk reduction while reducing barriers to risk reduction found in austere rural environments. The targeted CVD risk factors were measured at baseline and 4 and 12 months post-intervention. Repeated measures data were analyzed with mixed models. Results More individuals in the intervention group compared to the control group met their lifestyle change goal (50% vs 16%, p<0.001). The intervention produced a positive impact on systolic blood pressure (p=0.002, time X group effect), diastolic blood pressure (p=0.001, time x group), total cholesterol (p=0.026, time x group), high density lipoprotein (p=0.002, time x group), body mass index (p=0.017, time x group), smoking status (p=0.01), depressive symptoms (p=0.01, time x group), and steps per day (p=0.001, time x group). Compared to the control group, improvement was seen at 4 months in these risk factors and the positive changes were maintained through 12 months. There were no differences seen across time by group in low density lipoprotein or triglyceride levels. Conclusion Interventions like HeartHealth that focus on self-care and that are derived in collaboration with the community of interest are effective in medically underserved, socioeconomically distressed rural areas. Acknowledgement/Funding Patient Centered Outcomes Research Institute

scholarly journals A double-blind randomized controlled trial of the local application of vancomycin versus ampicillin powder into the operative field for thoracic and/or lumbar fusions

2018 ◽  
Vol 29 (5) ◽  
pp. 553-559 ◽  
Author(s):  
Mikinobu Takeuchi ◽  
Norimitsu Wakao ◽  
Mitsuhiro Kamiya ◽  
Atsuhiko Hirasawa ◽  
Kenta Murotani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Lumbar Fusion ◽  
Controlled Trial ◽  
Deep Infection ◽  
Local Application ◽  
Control Group ◽  
Operative Field ◽  
Double Blind ◽  
Randomized Controlled ◽  
Group 1

OBJECTIVERetrospective studies have reported that the local application of vancomycin (VCM) powder into the operative field decreases the incidence of surgical site infection (SSI) in thoracic and/or lumbar fusion. Authors of the present study prospectively evaluated the effects of VCM in patients undergoing thoracic and/or lumbar fusion.METHODSIn this randomized double-blind trial, 230 patients undergoing thoracic and/or lumbar fusion were randomly assigned to the local administration of VCM (interventional group, 1 g) or ampicillin (AMP; control group, 1 g) into the surgical field. The primary outcome was SSI results within 1 year of surgery.RESULTSThe trial was prematurely stopped according to predetermined rules. The results showed one superficial infection (0.9%, Staphylococcus aureus) and one deep infection (0.9%, S. aureus) in the VCM group and two superficial infections (1.8%, Staphylococcus epidermidis and culture negative) and one deep infection (0.9%, methicillin-resistant S. aureus) in the AMP group. No significant differences in infection rates were observed between the groups (p = 0.8).CONCLUSIONSThis double-blind randomized controlled trial demonstrated that the local application of VCM or AMP powder into the operative field in short thoracic and/or lumbar fusion procedures resulted in a similar incidence of SSI.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class III.Clinical trial registration no.: UMIN000009377 (umin.ac.jp/ctr)

Sign in / Sign up

Export Citation Format

Share Document