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Article ; Online: Clonidine in pediatric anesthesia: the new panacea or a drug still looking for an indication?

Afshari, Arash

2019 Volume 32, Issue 3, Page(s) 327–333

Abstract: Purpose of review: Clonidine, an α2-receptor agonist is a widely used drug in pediatrics with a large scope of indications ranging from prevention of postoperative emergence agitation, analgesia, anxiolysis, sedation, weaning to shivering. In the era of ...

Abstract	Purpose of review: Clonidine, an α2-receptor agonist is a widely used drug in pediatrics with a large scope of indications ranging from prevention of postoperative emergence agitation, analgesia, anxiolysis, sedation, weaning to shivering. In the era of 'opioid-free' medicine with much attention be directed toward increasing problems with opioid use, clonidine due to its global availability, low cost and safety profile has become an even more interesting option. Recent findings: Increasing evidence from randomised clinical trials support the use of clonidine in healthy children in the perioperative setting. Clonidine appears to significantly reduce postoperative emergence agitation, opioid consumption, shivering, nausea and vomiting. In addition, emerging evidence support the use of clonidine for sedation of critically ill children in ICUs. In this review, the current evidence for clonidine in pediatrics is described and analyzed including a meta-analysis for prevention of emergence agitation. Summary: Clonidine appears a safe and beneficial drug with moderate to high-quality evidence supporting its use in pediatric anesthesia. However, for some indications and populations such as children younger than 12 months old and those with hemodynamic instability, there is an urgent need for high-quality trials.
MeSH term(s)	Adrenergic alpha-2 Receptor Agonists/administration & dosage ; Adrenergic alpha-2 Receptor Agonists/adverse effects ; Age Factors ; Anesthesia/adverse effects ; Anesthesia/methods ; Child ; Clonidine/administration & dosage ; Clonidine/adverse effects ; Emergence Delirium/etiology ; Emergence Delirium/prevention & control ; Humans ; Patient Selection ; Postoperative Nausea and Vomiting/etiology ; Postoperative Nausea and Vomiting/prevention & control ; Randomized Controlled Trials as Topic ; Shivering/drug effects
Chemical Substances	Adrenergic alpha-2 Receptor Agonists ; Clonidine (MN3L5RMN02)
Language	English
Publishing date	2019-05-02
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	645203-6
ISSN	1473-6500 ; 0952-7907
ISSN (online)	1473-6500
ISSN	0952-7907
DOI	10.1097/ACO.0000000000000724
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Is clinical heterogeneity the foremost prominent threat to the validity of meta-analyses?

Fabritius, Maria Louise / Afshari, Arash

Acta anaesthesiologica Scandinavica

2021 Volume 65, Issue 7, Page(s) 863–864

Language	English
Publishing date	2021-06-16
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	80002-8
ISSN	1399-6576 ; 0001-5172
ISSN (online)	1399-6576
ISSN	0001-5172
DOI	10.1111/aas.13852
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Article ; Online: A new era for troponins in clinical practice guidelines.

Foex, Pierre / Afshari, Arash / Kranke, Peter / Romero, Carolina S

European journal of anaesthesiology

2023 Volume 40, Issue 12, Page(s) 879–883

MeSH term(s)	Humans ; Biomarkers ; Myocardial Infarction ; Myocardium ; Troponin ; Troponin T ; Practice Guidelines as Topic
Chemical Substances	Biomarkers ; Troponin ; Troponin T
Language	English
Publishing date	2023-11-08
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	605770-6
ISSN	1365-2346 ; 0265-0215
ISSN (online)	1365-2346
ISSN	0265-0215
DOI	10.1097/EJA.0000000000001909
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Article ; Online: The rationale for the recommendations of the European Paediatric Fasting Guideline: Improving paediatric anaesthesia and perioperative medicine.

Frykholm, Peter / Disma, Nicola / Kranke, Peter / Afshari, Arash

European journal of anaesthesiology

2021 Volume 39, Issue 1, Page(s) 1–3

MeSH term(s)	Anesthesia/adverse effects ; Child ; Fasting ; Humans ; Perioperative Care ; Perioperative Medicine
Language	English
Publishing date	2021-12-02
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	605770-6
ISSN	1365-2346 ; 0265-0215
ISSN (online)	1365-2346
ISSN	0265-0215
DOI	10.1097/EJA.0000000000001587
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Article ; Online: Clinical guideline on reversal of direct oral anticoagulants in patients with life threatening bleeding.

Grottke, Oliver / Afshari, Arash / Ahmed, Aamer / Arnaoutoglou, Eleni / Bolliger, Daniel / Fenger-Eriksen, Christian / von Heymann, Christian

European journal of anaesthesiology

2024 Volume 41, Issue 5, Page(s) 327–350

Abstract: Background: Anticoagulation is essential for the treatment and prevention of thromboembolic events. Current guidelines recommend direct oral anticoagulants (DOACs) over vitamin K antagonists in DOAC-eligible patients. The major complication of ... ...

Abstract	Background: Anticoagulation is essential for the treatment and prevention of thromboembolic events. Current guidelines recommend direct oral anticoagulants (DOACs) over vitamin K antagonists in DOAC-eligible patients. The major complication of anticoagulation is serious or life-threatening haemorrhage, which may necessitate prompt haemostatic intervention. Reversal of DOACs may also be required for patients in need of urgent invasive procedures. This guideline from the European Society of Anaesthesiology and Intensive Care (ESAIC) aims to provide evidence-based recommendations and suggestions on how to manage patients on DOACs undergoing urgent or emergency procedures including the treatment of DOAC-induced bleeding. Design: A systematic literature search was performed, examining four drug comparators (dabigatran, rivaroxaban, apixaban, edoxaban) and clinical scenarios ranging from planned to emergency surgery with the outcomes of mortality, haematoma growth and thromboembolic complications. The GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology was used to assess the methodological quality of the included studies. Consensus on the wording of the recommendations was achieved by a Delphi process. Results: So far, no results from prospective randomised trials comparing two active comparators (e.g. a direct reversal agent and an unspecific haemostatic agent such as prothrombin complex concentrate: PCC) have been published yet and the majority of publications were uncontrolled and observational studies. Thus, the certainty of evidence was assessed to be either low or very low (GRADE C). Thirty-five recommendations and clinical practice statements were developed. During the Delphi process, strong consensus (>90% agreement) was achieved in 97.1% of recommendations and consensus (75 to 90% agreement) in 2.9%. Discussion: DOAC-specific coagulation monitoring may help in patients at risk for elevated DOAC levels, whereas global coagulation tests are not recommended to exclude clinically relevant DOAC levels. In urgent clinical situations, haemostatic treatment using either the direct reversal or nonspecific haemostatic agents should be started without waiting for DOAC level monitoring. DOAC levels above 50 ng ml-1 may be considered clinically relevant necessitating haemostatic treatment before urgent or emergency procedures. Before cardiac surgery under activated factor Xa (FXa) inhibitors, the use of andexanet alfa is not recommended because of inhibition of unfractionated heparin, which is needed for extracorporeal circulation. In the situation of DOAC overdose without bleeding, no haemostatic intervention is suggested, instead measures to eliminate the DOACs should be taken. Due to the lack of published results from comparative prospective, randomised studies, the superiority of reversal treatment strategy vs. a nonspecific haemostatic treatment is unclear for most urgent and emergency procedures and bleeding. Due to the paucity of clinical data, no recommendations for the use of recombinant activated factor VII as a nonspecific haemostatic agent can be given. Conclusion: In the clinical scenarios of DOAC intake before urgent procedures and DOAC-induced bleeding, practitioners should evaluate the risk of bleeding of the procedure and the severity of the DOAC-induced bleeding before initiating treatment. Optimal reversal strategy remains to be determined in future trials for most clinical settings.
MeSH term(s)	Humans ; Heparin/therapeutic use ; Prospective Studies ; Hemorrhage/prevention & control ; Anticoagulants ; Hemostatics/therapeutic use ; Administration, Oral
Chemical Substances	Heparin (9005-49-6) ; Anticoagulants ; Hemostatics
Language	English
Publishing date	2024-04-04
Publishing country	England
Document type	Journal Article
ZDB-ID	605770-6
ISSN	1365-2346 ; 0265-0215
ISSN (online)	1365-2346
ISSN	0265-0215
DOI	10.1097/EJA.0000000000001968
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Article ; Online: Adapt or perish: Introducing focused guidelines.

Romero, Carolina S / Afshari, Arash / Kranke, Peter

European journal of anaesthesiology

2021 Volume 38, Issue 8, Page(s) 803–805

Language	English
Publishing date	2021-07-02
Publishing country	England
Document type	Editorial
ZDB-ID	605770-6
ISSN	1365-2346 ; 0265-0215
ISSN (online)	1365-2346
ISSN	0265-0215
DOI	10.1097/EJA.0000000000001535
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Article ; Online: Decoding the meaning of medical guidelines and their medicolegal implications.

Kranke, Peter / Afshari, Arash / Meybohm, Patrick / Buhre, Wolfgang / Wiege, Stephanie / Romero, Carolina S

European journal of anaesthesiology

2023 Volume 41, Issue 2, Page(s) 109–114

Abstract: Medical practice guidelines (MPGs) are important in medicine to ensure well tolerated and effective healthcare. They provide evidence-based recommendations for healthcare professionals in daily clinical settings. MPGs help patients and practitioners make ...

Abstract	Medical practice guidelines (MPGs) are important in medicine to ensure well tolerated and effective healthcare. They provide evidence-based recommendations for healthcare professionals in daily clinical settings. MPGs help patients and practitioners make informed decisions, ensure quality of care, allocate healthcare resources effectively and reduce legal liability. MPGs have medicolegal implications, as they influence clinical decision-making and patient outcomes, which can impact liability and malpractice cases. They define the standard of care within the healthcare industry and provide best practice recommendations. MPGs are a cornerstone of the informed consent process, as they facilitate a shared decision support system and they provide valuable evidence-based recommendations on various treatments or medical options. Finally, MPGs are also relevant in medical claims; thus, adherence to MPGs is highly encouraged in order to assure the best medical care. Nonetheless, MPGs have limitations and we advocate for wise usage of MPGs combined with the expertise of trained physicians that allows for individualisation and evidence-based recommendations. In this review, we describe the potential legal implications that MPGs may represent for healthcare providers and the role that MPGs have in daily practice at different stages in the doctor--patient relationship.
MeSH term(s)	Humans ; Malpractice ; Delivery of Health Care
Language	English
Publishing date	2023-10-19
Publishing country	England
Document type	Review ; Journal Article
ZDB-ID	605770-6
ISSN	1365-2346 ; 0265-0215
ISSN (online)	1365-2346
ISSN	0265-0215
DOI	10.1097/EJA.0000000000001917
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Article ; Online: Clonidine for preventing emergence agitation in infants (PREVENT AGITATION II): Protocol and statistical analysis plan.

Garioud, Anne Louise de Barros / Nielsen, Bettina Nygaard / Falcon, Lars / Mondrup, Frederik / Afshari, Arash

Acta anaesthesiologica Scandinavica

2023 Volume 67, Issue 5, Page(s) 663–669

Abstract: Background: Emergence agitation is a common clinical condition in children. Symptoms pertaining to the spectrum of early postoperative negative behavior typically occur upon emergence from anesthesia. Clonidine is an effective adjunctive agent for the ... ...

Abstract	Background: Emergence agitation is a common clinical condition in children. Symptoms pertaining to the spectrum of early postoperative negative behavior typically occur upon emergence from anesthesia. Clonidine is an effective adjunctive agent for the prevention of emergence agitation in children, but evidence in the smallest age groups is sparse We aim to investigate the efficacy and safety of an intraoperative bolus of intravenous clonidine for preventing emergence agitation in children 3-12 months of age. Methods: This is a randomized, placebo-controlled, double-blind trial. We will enroll 320 patients aged 3-12 months who have been scheduled for general anesthesia maintained with sevoflurane and opioid. The randomization is parallel and stratified by age group, sex, and site. The investigational medicinal product will be administered intravenously ~20 min before the anticipated end of the surgical procedure. The intervention is clonidine 3 μg/kg and placebo is isotonic saline in a corresponding volume. Results: The primary outcome is the incidence of emergence agitation as assessed on the Watcha scale, that is, any Watcha score >2 during participants' stay in the postanesthetic care unit. Secondary outcomes are the proportion of participants with postoperative pain, with postoperative nausea and vomiting, and a composite safety outcome. Statistical analysis will be conducted according to the Statistical Analysis Plan with the intention-to-treat population for our primary analyses. Conclusion: The PREVENT AGITATION II trial will contribute valuable knowledge on efficacy for the prevention of emergence agitation and safety in infants.
MeSH term(s)	Child ; Humans ; Infant ; Clonidine/therapeutic use ; Emergence Delirium/prevention & control ; Anesthetics, Inhalation ; Sevoflurane ; Anesthesia, General/adverse effects ; Psychomotor Agitation/prevention & control ; Psychomotor Agitation/epidemiology ; Double-Blind Method ; Anesthesia Recovery Period ; Methyl Ethers ; Randomized Controlled Trials as Topic
Chemical Substances	Clonidine (MN3L5RMN02) ; Anesthetics, Inhalation ; Sevoflurane (38LVP0K73A) ; Methyl Ethers
Language	English
Publishing date	2023-02-27
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	80002-8
ISSN	1399-6576 ; 0001-5172
ISSN (online)	1399-6576
ISSN	0001-5172
DOI	10.1111/aas.14212
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Article ; Online: Pitfalls of clinical practice guidelines in the era of broken science: Let's raise the standards.

Afshari, Arash / De Hert, Stefan

European journal of anaesthesiology

2018 Volume 35, Issue 12, Page(s) 903–906

MeSH term(s)	Anesthesiology/standards ; Humans ; Practice Guidelines as Topic/standards ; Societies, Medical/standards
Language	English
Publishing date	2018-10-29
Publishing country	England
Document type	Editorial
ZDB-ID	605770-6
ISSN	1365-2346 ; 0265-0215
ISSN (online)	1365-2346
ISSN	0265-0215
DOI	10.1097/EJA.0000000000000892
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Article ; Online: Evidence based evaluation of immuno-coagulatory interventions in critical care.

Afshari, Arash

Danish medical bulletin

2011 Volume 58, Issue 9, Page(s) B4316

Abstract: Unlabelled: Cochrane systematic reviews with meta-analyses of randomised trials provide guidance for clinical practice and health-care decision-making. In case of disagreements between research evidence and clinical practice, high quality systematic ... ...

Abstract	Unlabelled: Cochrane systematic reviews with meta-analyses of randomised trials provide guidance for clinical practice and health-care decision-making. In case of disagreements between research evidence and clinical practice, high quality systematic reviews can facilitate implementation or deimplementation of medical interventions into clinical practice. This applies especially to treatment of critically ill patients where interventions are most often costly and the clinical conditions are associated with high mortality. Objectives: To assess the potential benefits or harms of 1) antithrombin III (AT III) for critically ill patients; 2) inhaled nitric oxide (INO) for acute respiratory distress syndrome (ARDS) and acute lung injury (ALI); 3) aerosolized prostacyclin for ARDS and ALI; 4) thrombelastography (TEG) or thromboelastometry (ROTEM) to monitor haemotherapy versus usual care in patients with massive transfusion. Methods: We performed four systematic reviews of relevant randomised clinical trials. To quantify the estimated effect of various interventions, we conducted meta-analyses, where appropriate, to determine intervention effects using the Cochrane Collaboration methodology, trial sequential analyses (TSA), the GRADE, and the PRISMA-guidelines when conducting our systematic reviews. All reviews were performed according to published protocols following the recommendations of the Cochrane Handbook for systematic reviews of interventions. We performed multiple subgroup and sensitivity analyses with regard to methodological quality and various clinical outcomes. Trials were identified through Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE Science Citation Index-Expanded, The Chinese Biomedical Database and LILACS. We included all randomized clinical trials. We hand-searched reference lists, reviews, and contacted authors and experts for additional trials. We searched ClinicalTrials.gov, Centre Watch Clinical Trials Listing Service and ControlledTrials.com for missed, unreported, or ongoing trials. We screened bibliographies of relevant articles and conference proceedings and wrote to trialists and pharmaceutical companies producing the drugs in question. Results: Four systematic reviews included a total of 44 trials with 5,551 patients. Only 15 of the trials were classified as trials with low risk of bias (high methodological quality) regarding generation of the allocation sequence, allocation concealment, blinding, follow-up and other types of bias. 1) Compared with placebo or no intervention, AT III did not significantly affect overall mortality (relative risk (RR) 0.96, 95% confidence interval (CI) 0.89 to 1.03). No subgroup analyses on risk of bias, populations of patients, or with and without adjuvant heparin yielded significant results. AT III significantly increased the risk of bleeding events (RR 1.52, 95% CI 1.30 to 1.78). 2) INO showed no statistically significant effect on overall mortality (RR 1.06, 95% CI 0.93 to 1.22) and in several subgroup and sensitivity analyses, indicating robust results. Limited data demonstrated no effect of INO on duration of ventilation, ventilator-free days, and length of stay in the intensive care unit and hospital. We found a statistically significant, but transient improvement in oxygenation in the first 24 hours, expressed as the ratio of PO2 to fraction of inspired oxygen (mean difference (MD) 15.91, 95% CI 8.25 to 23.56). However, INO appears to significantly increase the risk of renal impairment among adults (RR 1.59, 95% CI 1.17 to 2.16) but did not significantly affect the risk of bleeding or methaemoglobin or nitrogen dioxide formation. 3) We found only one small low risk of bias paediatric trial examining the role of aerosolized prostacyclin in ALI or ARDS. Based on this limited amount of data, we were unable to support or refute the routine use of this intervention in ALI or ARDS. 4) Compared with standard treatment, TEG or ROTEM showed no statistically significant effect on overall mortality (RR 0.77, 95% CI 0.35 to 1.72) but only five trials provided data on mortality. Our analyses demonstrated a statistically significant effect of TEG or ROTEM on the amount of bleeding (MD -85.05 ml, 95% CI -140.68 to -29.42) but failed to show any statistically significant effect on other predefined outcomes. However, whether this reduction has implication for the patient's clinical condition is still uncertain. Conclusion: We did not find reliable evidence to support the clinical use of the assessed immuno-coagulatory interventions for general use in critical care based on the available evidence. A large proportion of the trials had serious methodological shortcomings, small number of patients, and short trial duration. The sparse data provided in the included trials may be or may not be promising but is not necessarily evidence of absence of a beneficial or harmful effect, because many of the outcome measures have not been adequately addressed so far. There is an urgent need for several randomised clinical trials with low risk of bias and low risk of random error to evaluate the use of the assessed interventions.
MeSH term(s)	Adult ; Antithrombin III/therapeutic use ; Blood Coagulation/physiology ; Blood Coagulation Disorders/drug therapy ; Blood Coagulation Disorders/physiopathology ; Critical Care ; Epoprostenol/therapeutic use ; Evidence-Based Medicine/methods ; Hemostasis/physiology ; Humans ; Inflammation/blood ; Inflammation/drug therapy ; Nitric Oxide/therapeutic use
Chemical Substances	Nitric Oxide (31C4KY9ESH) ; Antithrombin III (9000-94-6) ; Epoprostenol (DCR9Z582X0)
Language	English
Publishing date	2011-09
Publishing country	Denmark
Document type	Journal Article ; Meta-Analysis ; Review
ZDB-ID	124108-4
ISSN	1603-9629 ; 0011-6092 ; 0901-6929 ; 0907-8916
ISSN (online)	1603-9629
ISSN	0011-6092 ; 0901-6929 ; 0907-8916
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