scholarly journals Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Gabby T. J. A. Reijnders-Boerboom ◽  
Esmee V. van Helden ◽  
Robert C. Minnee ◽  
Kim I. Albers ◽  
Moira H. D. Bruintjes ◽  
...  
Keyword(s):  
Neuromuscular Blockade ◽  
Donor Nephrectomy ◽  
Abdominal Pressure ◽  
Controlled Trials ◽  
Multiple Logistic Regression ◽  
Regression Analyses ◽  
Laparoscopic Donor Nephrectomy ◽  
Randomized Controlled ◽  
Link Type ◽  
Operative Complications

Abstract Study objective To assess whether different intensities of intra-abdominal pressure and deep neuromuscular blockade influence the risk of intra-operative surgical complications during laparoscopic donor nephrectomy. Design A pooled analysis of ten previously performed prospective randomized controlled trials. Setting Laparoscopic donor nephrectomy performed in four academic hospitals in the Netherlands: Radboudumc, Leiden UMC, Erasmus MC Rotterdam, and Amsterdam UMC. Patients Five hundred fifty-six patients undergoing a transperitoneal, fully laparoscopic donor nephrectomy enrolled in ten prospective, randomized controlled trials conducted in the Netherlands from 2001 to 2017. Interventions Moderate (tetanic count of four > 1) versus deep (post-tetanic count 1–5) neuromuscular blockade and standard (≥10 mmHg) versus low (<10 mmHg) intra-abdominal pressure. Measurements The primary endpoint is the number of intra-operative surgical complications defined as any deviation from the ideal intra-operative course occurring between skin incision and closure with five severity grades, according to ClassIntra. Multiple logistic regression analyses were used to identify predictors of intra- and postoperative complications. Main results In 53/556 (9.5%) patients, an intra-operative complication with ClassIntra grade ≥ 2 occurred. Multiple logistic regression analyses showed standard intra-abdominal pressure (OR 0.318, 95% CI 0.118–0.862; p = 0.024) as a predictor of less intra-operative complications and moderate neuromuscular blockade (OR 3.518, 95% CI 1.244–9.948; p = 0.018) as a predictor of more intra-operative complications. Postoperative complications occurred in 31/556 (6.8%), without significant predictors in multiple logistic regression analyses. Conclusions Our data indicate that the use of deep neuromuscular blockade could increase safety during laparoscopic donor nephrectomy. Future randomized clinical trials should be performed to confirm this and to pursue whether it also applies to other types of laparoscopic surgery. Trial registration Clinicaltrials.gov LEOPARD-2 (NCT02146417), LEOPARD-3 trial (NCT02602964), and RELAX-1 study (NCT02838134), Klop et al. (NTR 3096), Dols et al. 2014 (NTR1433).

scholarly journals Quality of Recovery After Low-Pressure Laparoscopic Donor Nephrectomy Facilitated by Deep Neuromuscular Blockade: A Randomized Controlled Study

2017 ◽  
Vol 41 (11) ◽  
pp. 2950-2958 ◽  
Author(s):  
Denise M. D. Özdemir-van Brunschot ◽  
Gert J. Scheffer ◽  
Michel van der Jagt ◽  
Hans Langenhuijsen ◽  
Albert Dahan ◽  
...  
Keyword(s):  
Neuromuscular Blockade ◽  
Low Pressure ◽  
Donor Nephrectomy ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Laparoscopic Donor Nephrectomy ◽  
Quality Of Recovery ◽  
Randomized Controlled

scholarly journals Erratum to: Quality of Recovery After Low-Pressure Laparoscopic Donor Nephrectomy Facilitated by Deep Neuromuscular Blockade: A Randomized Controlled Study

2017 ◽  
Vol 41 (11) ◽  
pp. 2949-2949
Author(s):  
Denise M. D. Özdemir-van Brunschot ◽  
Gert J. Scheffer ◽  
Michel van der Jagt ◽  
Johan F. Langenhuijsen ◽  
Albert Dahan ◽  
...  
Keyword(s):  
Neuromuscular Blockade ◽  
Low Pressure ◽  
Donor Nephrectomy ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Laparoscopic Donor Nephrectomy ◽  
Quality Of Recovery ◽  
Randomized Controlled

scholarly journals Randomized, double-blinded, controlled non-inferiority trials evaluating the immunogenicity and safety of fractional doses of Yellow Fever vaccines in Kenya and Uganda

2019 ◽  
Vol 4 ◽  
pp. 182 ◽  
Author(s):  
Derick Kimathi ◽  
Aitana Juan ◽  
Philip Bejon ◽  
Rebecca F. Grais ◽  
George M. Warimwe ◽  
...  
Keyword(s):  
Immune Response ◽  
Randomized Controlled Trials ◽  
Yellow Fever ◽  
Vaccine Dose ◽  
World Health ◽  
Yellow Fever Vaccine ◽  
Controlled Trials ◽  
Post Vaccination ◽  
Randomized Controlled ◽  
Link Type

Introduction: Yellow fever is endemic in specific regions of sub-Saharan Africa and the Americas, with recent epidemics occurring on both continents. The yellow fever vaccine is effective, affordable and safe, providing life-long immunity following a single dose vaccination. However, the vaccine production process is slow and cannot be readily scaled up during epidemics. This has led the World Health Organization (WHO) to recommend the use of fractional doses as a dose-sparing strategy during epidemics, but there are no randomized controlled trials of fractional yellow fever vaccine doses in Africa. Methods and analysis: We will recruit healthy adult volunteers, adults living with HIV, and children to a series of randomized controlled trials aiming to determine the immunogenicity and safety of fractional vaccine doses in comparison to the standard vaccine dose. The trials will be conducted across two sites; Kilifi, Kenya and Mbarara, Uganda. Recruited participants will be randomized to receive fractional or standard doses of yellow fever vaccine. Scheduled visits will include blood collection for serum and peripheral blood mononuclear cells (PBMCs) before vaccination and on various days – up to 2 years – post-vaccination. The primary outcome is the rate of seroconversion as measured by the plaque reduction neutralization test (PRNT50) at 28 days post-vaccination. Secondary outcomes include antibody titre changes, longevity of the immune response, safety assessment using clinical data, the nature and magnitude of the cellular immune response and post-vaccination control of viremia by vaccine dose. Ethics and dissemination: The clinical trial protocols have received approval from the relevant institutional ethics and regulatory review committees in Kenya and Uganda, and the WHO Ethics Review Committee. The research findings will be disseminated through open-access publications and presented at relevant conferences and workshops. Registration: ClinicalTrials.gov NCT02991495 (registered on 13 December 2016) and NCT04059471 (registered on 15 August 2019).

scholarly journals Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

2019 ◽  
Vol 2019 ◽  
pp. 1-21
Author(s):  
Meng-Qi Yang ◽  
Yong-Mei Song ◽  
Huan-Yu Gao ◽  
Yi-Tao Xue
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
High Quality ◽  
Randomized Controlled ◽  
Link Type

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.

Randomized Controlled Trial Comparing Hand-Assisted Retroperitoneoscopic Versus Standard Laparoscopic Donor Nephrectomy

2014 ◽  
Vol 97 (2) ◽  
pp. 161-167 ◽  
Author(s):  
Leonienke F.C. Dols ◽  
Niels F.M. Kok ◽  
Frank C.H. d’Ancona ◽  
Karel W.J. Klop ◽  
T.C. Khe Tran ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Donor Nephrectomy ◽  
Laparoscopic Donor Nephrectomy ◽  
Randomized Controlled
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