Vibration anesthesia during carboxytherapy for cellulite: a study protocol

Background: To date, there has been no investigation addressing the effects of vibration anesthesia during carboxytherapy. Aim: Investigate the analgesic effect of different vibratory devices during carboxytherapy for the treatment of cellulite. Materials & methods: A total of 78 women between 18 and 49 years of age with cellulite in the gluteal region will be randomly allocated to three groups: Group A (carboxytherapy and vibratory device A), Group B (carboxytherapy and vibratory device B) and control group. Pain intensity will be assessed using a numerical rating scale after each puncture. Expected outcome: Vibration anesthesia is expected to be effective at diminishing the pain intensity caused by carboxytherapy comparison with the control group, with no differences between the vibratory devices. Trial registry: Brazilian Registry of Clinical Trials- ReBEC (RBR-8jcqy7c)

The effect of obstructive jaundice on the sensitivity of intravenous anesthetic of remimazolam: study protocol for a controlled multicenter trial

Background It is well known that obstructive jaundice could affect the pharmacodynamics of some anesthetics, and the sensitivity of some anesthetics would increase among icteric patients. Remimazolam is a new ultra-short-acting intravenous benzodiazepine sedative/anesthetic, which is a high-selective and affinity ligand for the benzodiazepine site on the GABAA receptor. However, no study has reported the pharmacodynamics of remimazolam in patients with obstructive jaundice. We hypothesize that obstructive jaundice affects the pharmacodynamics of remimazolam, and the sensitivity of remimazolam increases among icteric patients. Methods/design The study will be performed as a prospective, controlled, multicenter trial. The study design is a comparison of remimazolam requirements to reach a bispectral index of 50 in patients with obstructive jaundice versus non-jaundiced patients with chronic cholecystitisor intrahepatic bile duct stones. Remimazolam was infused at 6 mg/kg/h until this endpoint was reached. Discussion Remimazolam could be suitable for anesthesia of patients with obstructive jaundice, because remimazolam is not biotransformed in the liver. Hyperbilirubinemia has been well-described to have toxic effects on the brain, which causes the increasing of sensitivity to some anesthetics, such as desflurane, isoflurane, and etomidate. Furthermore, remimazolam and etomidate have the same mechanism of action when exerting an anesthetic effect. We aim to demonstrate that obstructive jaundice affects the pharmacodynamics of remimazolam, and the dose of remimazolam when administered to patients with obstructive jaundice should be modified. Trial registration Chinese Clinical Trial Registry ChiCTR2100043585. Registered on 23 February 2021

Effect of Nudge-Based Intervention on Adherence to Physician Visit Recommendations and Early Health Outcomes among Individuals Identified with Chronic Kidney Disease in Screens

BackgroundAlthough CKD screening programs have been provided in many settings, little is known as to how we can effectively translate those screening programs into improved health.MethodsWe conducted a randomized clinical trial on national health screening for CKD in Japan between April 2018 and March 2019. A total of 4011 participants in CKD screening programs aged 40–63 years were randomly assigned to two interventions or the control, with a ratio of 2:2:1, respectively: (1) the nudge-based letter that contained a message on the basis of behavioral economics, (2) the clinical letter including general information about CKD risks, and (3) the control (informed only of the screening results). The main outcome was adherence to a recommended physician visit within 6 months of the intervention. The secondary outcomes were eGFR, proteinuria, and BP 1 year after the intervention.ResultsCompared with the control group, the probability of undergoing a recommended physician visit was higher among participants who received the nudge-based letter (19.7% for the intervention group versus 15.8% for the control; difference, +3.9 percentage points [pp]; 95% CI, +0.8 to +7.0; P=0.02) and the clinical letter (19.7% versus 15.8%; difference, +3.9 pp; 95% CI, +0.8 to +7.0; P=0.02). We found no evidence that interventions were associated with improved early health outcomes.ConclusionsThe behavioral economics intervention tested in this large RCT had limited effect on changing behavior or improving health outcomes. Although the approach has promise, this study demonstrates the challenge of developing behavioral interventions that improve the effectiveness of CKD screening programs.Clinical Trial registry name and registration number: University Hospital Medical Information Network Clinical Trial Registry, UMIN000035230

Placental Iron Content is Lower than Previously Estimated and is Associated with Maternal Iron Status in Women at Greater Risk for Gestational Iron Deficiency and Anemia

Background Based on limited data, it is estimated that the placenta retains 90 mg of iron (Fe). Little is known about determinants of placental Fe content. Animal data indicate that the placenta prioritizes Fe for its own needs, but this hypothesis has not been evaluated in humans. Objectives To characterize placental Fe content and placental Fe concentration (p[Fe]) in pregnant women at risk of Fe insufficiency and identify determinants of p[Fe]. Methods Placentae were collected from 132 neonates born to teens carrying singletons (≤18 y) and 101 neonates born to 48 women carrying multiples (20–46 y). Maternal and neonatal Fe status indicators (hemoglobin, SF, sTfR, serum Fe, TBI) and hormones (erythropoietin, hepcidin) were measured. P[Fe] was measured using ICP-MS. Correlation analyses and mixed-effects models were constructed to identify determinants of p[Fe]. Results Mean placental Fe content was 23 mg per placenta [95%CI 15–33] in the multiples and 40 mg [95%CI 31–51] in the teens (P = 0.03). Mean p[Fe] did not differ between the cohorts. P[Fe] was higher in anemic (175 [95%CI 120–254] μg/g) compared to non-anemic (46 [95%CI 26–82] μg/g) women carrying multiples (P = 0.009), but did not differ between anemic (62 [95%CI 40–102] μg/g) and non-anemic (73 [95%CI 56–97] μg/g) teens. In women carrying multiples, low maternal Fe status [lower SF (P = 0.002) and lower TBI (P = 0.01)] was associated with higher p[Fe], while in teens, improved Fe status [lower sTfR (P = 0.03) and higher TBI (P = 0.03)] was associated with higher p[Fe]. Conclusions Placental Fe content was ∼50% lower than previously estimated. P[Fe] is significantly associated with maternal Fe status. In women carrying multiples, poor maternal Fe status was associated with higher p[Fe], while in teens, improved Fe status was associated with higher p[Fe]. More data are needed to understand determinants of p[Fe] and the variable Fe partitioning in teens compared to mature women. Clinical Trial Registry: These clinical trials were registered at clinicaltrials.gov as NCT01019902 (https://clinicaltrials.gov/ct2/show/NCT01019902) and NCT01582802 (https://clinicaltrials.gov/ct2/show/NCT01582802).

Gonioscopy-assisted transluminal trabeculotomy versus goniotomy with Kahook dual blade in patients with uncontrolled juvenile open-angle glaucoma: a retrospective study

Background To compare the efficacy and safety of gonioscopy-assisted transluminal trabeculotomy (GATT) and Kahook Dual Blade (KDB) excisional goniotomy in patients with uncontrolled juvenile open-angle glaucoma (JOAG). Methods Thirty-three patients (46 eyes) were included in this single-center, retrospective, comparative study and treated with GATT (36 eyes) or KDB goniotomy (13 eyes). Intraocular pressure (IOP), number of glaucoma medications, adverse events, and additional anti-glaucoma procedures were collected during pre- and postoperative visits. Surgical success was defined as 6 mmHg ≤ IOP ≤ 18 mmHg and ≥ 20% IOP reduction from baseline with (partial success) or without (complete success) IOP-lowering medications. Results The mean ± SD preoperative IOP was 30.48 ± 12.9 mmHg and 26.08 ± 13.1 mmHg (P = 0.164) on 3.71 ± 0.46 and 3.08 ± 0.86 (P = 0.023) glaucoma medications in GATT and KDB group, respectively. At 3 months, the mean ± SD IOP was 15.48 ± 5.93 mmHg and 20.0 ± 10.8 mmHg after GATT and KDB, respectively (P = 0.072). The percentage of IOP lowering from baseline was 44.4 in the GATT group and 14.1 in the KDB group (P = 0.011). The mean reduction in medications was 2.6 ± 1.7 and 0.8 ± 1.2 three months after GATT and KDB, respectively (P < 0.001). Cumulative proportion of partial and complete success were 65.6 and 44.7% in the GATT group, 30.8 and 15.4% in the KDB group at 6 months. Additional procedures were required in 13.9% of cases after GATT and in 61.5% after KDB (P = 0.001). Patients in the GATT group with prior anti-glaucoma procedures and postoperative IOP spikes were more likely to fail, while those with complete trabeculotomy had a better prognosis. Conclusions Reduction of IOP and medications were greater after GATT in uncontrolled JOAG eyes. Whereas, more additional IOP-lowering procedures were required after KDB goniotomy. Trial registration This study was registered under the Chinese Clinical Trial Registry (ChiCTR2000034172, 27/06/2020).

Transcutaneous electrical acupoint stimulation (TEAS) for cancer-related fatigue: study protocol for a systematic review and meta-analysis

IntroductionCancer-related fatigue (CRF) is a prevalent symptom in cancer survivors. Transcutaneous electrical acupoint stimulation (TEAS) has been reported as a promising therapy for CRF. This protocol is proposed for a systematic review that aims to assess the efficacy and safety of TEAS for CRF.Methods and analysisCochrane Central Register of Controlled Trials, PubMed, Medline, Embase, Chinese National Knowledge Infrastructure, VIP, Wanfang database, Chinese Biomedical Literature Database, Chinese Clinical Trial Registry System, ClinicalTrials.gov and WHO International Clinical Trial Registry Platform will be searched from inception to 31 January 2021 without language limitations. The eligible randomised controlled trials will be included. The primary outcomes include changes in the revised Piper fatigue scale, the Brief fatigue inventory, the Multidimensional fatigue inventory and the Functional assessment of chronic illness therapy fatigue. The secondary outcomes are the quality-of-life measurement index, the Hamilton anxiety scale, the Hamilton depression scale and adverse events. The selection of studies, data extraction and assessment of risk of bias will be conducted independently by two reviewers. Data synthesis will be performed using RevMan V.5.4.1. The quality of evidence will be evaluated with the Grading of Recommendations, Assessment, Development and Evaluation system. This study will strictly adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines.Ethics and disseminationEthical approval is not required as this is a systematic review and meta-analysis based on previously published studies involving no private information of patients. The results of this study will be disseminated in a peer-reviewed journal.PROSPERO registration numberCRD42020220282.

Characterisation of current pharmacotherapeutic COVID-19 clinical trials in India: A registry-based descriptive analysis

COVID-19 has emerged as a global pandemic. There is currently a spurt of clinical research to generate evidence to treat this novel disease. The aim of the current study is to characterise the pharmacotherapeutic intervention-related clinical trials registered in India. COVID-19 clinical trials registered in India were analysed from data retrieved from Clinical Trial Registry-India, ClinicalTrials.gov and International Clinical Trial Registry Platform. Parameters such as study design, sample size, pharmacotherapeutic interventions and primary outcomes were evaluated. A total of 267 studies were screened among which 103 clinical trials were assessed for descriptive analysis. Majority of registered trials (55.3%) were in Indian System of Medicine followed by antimalarials such as hydroxychloroquine/chloroquine (10.5%) and plasma therapy (7.1%). Most commonly used study design was randomised parallel group in 63%. Open-label study was seen in 47.5%. Primary outcome was improvement of clinical symptoms in 46.6% followed by rate and time of viral load reduction in 18.2%. Maharashtra (n = 35) followed by Delhi (n = 29) had the maximum number of registered trial sites. The study gives broad perspective on the current trend of clinical trials on COVID-19 being conducted in India. The outcomes of these trials will lead to generation of valuable data for evidence-based treatment of COVID-19.

Comparison of pretreatment with low-dose midazolam in combination with fentanyl and midazolam alone on the occurrence of etomidate-induced myoclonus—a randomized, double-blind study

Background Myoclonus is reported to occur in 50–80% of patients receiving etomidate in the absence of pretreatment. The study aimed to evaluate the efficacy of pretreatment with low-dose midazolam and fentanyl, and midazolam alone to reduce the occurrence of etomidate-induced myoclonus. Sixty patients were randomly divided into 2 groups. In group MF, patients received pretreatment with intravenous (IV) midazolam 0.015mg/kg in a volume of 5 ml normal saline, followed by IV fentanyl 1μg/kg in a volume of 5 ml normal saline. In group M, patients received pretreatment with IV midazolam 0.03mg/kg in a volume of 5 ml normal saline, followed by 5ml of IV normal saline. The test drug was injected over 30 s, and after 120 s, IV etomidate 0.3 mg/kg was injected over 30 s. The patients were observed for 120 s for myoclonus and graded as mild, moderate, or severe. Heart rate, blood pressure, and oxygen saturation were recorded immediately after test drug injection and at every minute for 5 min. Results The demographic parameters and hemodynamic parameters were comparable between the two groups. In group M, the incidence of myoclonus was 36.67% (26.67% mild and 10% moderate) whereas, in the group MF, the incidence of myoclonus was 26.67% (3.33% mild, 16.67% moderate, and 6.67% severe). This incidence of myoclonus was significantly lower in group MF (p=0.030). Conclusions The incidence of etomidate-induced myoclonus is significantly lower in patients pretreated with midazolam and fentanyl combination as compared to midazolam alone. Trial registration Clinical Trial Registry Details: CTRI/2019/05/018920

Patient perceptions of the challenges of recruitment to a renal randomised trial registry: a pilot questionnaire-based study

Background Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. However, issues of external validity often affect result application to real-world settings. Using registries to conduct RCTs is a reasonably new practice, but is appealing because it combines the benefits of both observational studies and RCTs. There is limited literature on patient motivators, barriers, and consent to registries for conducting RCTs. The purpose of our study was to establish the factors that motivate and/or inhibit patients from joining a registry for RCTs and to determine what information matters to patients when making an enrolment decision to participate in such a registry. Methods We conducted a cross-sectional questionnaire-based study at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis. Results Eighty-seven patients completed the questionnaire. Reasons for participation in a registry included personal and altruistic benefits. Barriers to participation were time and travel requirements associated with registry participation, data safety concerns, risks, side effects, and concerns that registry participation would impact current treatment. Although 29.8% of patients expressed concern regarding their data being stored in a registry, 79.3% were still willing to consent to have their data uploaded and stored in a registry for conducting RCTs. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management. Conclusion Challenges to recruitment to registries for RCTs exist, but addressing the identified concerns of potential participants may aid patients in making a more informed enrolment decision and may improve recruitment to registries, and by extension, to RCTs conducted using the registry.