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1.
Br J Anaesth ; 2024 Jul 11.
Article in English | MEDLINE | ID: mdl-38997841

ABSTRACT

BACKGROUND: Efficacy and safety of sugammadex for the reversal of neuromuscular blocking agents (NMBAs) in patients with neuromuscular diseases remains unclear. We summarised the available evidence and evaluated the quality of data reporting and the validity of published reports. METHODS: We searched for reports (any design) on the usage of sugammadex (any regimen) for the reversal of an NMBA in patients (any age) with any neuromuscular disease. We used a modified CARE checklist (maximum score 23) to assess the quality of data reporting and an original specific validity checklist (maximum score 41) that was developed through a Delphi process. RESULTS: We retrieved 126 observational reports (386 patients). Most dealt with myasthenia gravis patients receiving rocuronium. The train-of-four ratio returned to ≥0.9 in 258 of 265 (97.4%) patients in whom neuromonitoring was used. Adverse events occurred in 14 of 332 (4.2%) patients in whom adverse events were reported as present or absent. In 90 case reports, the median score of the 23-point CARE checklist was 13.5 (inter-quartile range [IQR] 11-16). In all 126 reports, the median score of the 41-point validity checklist was 23 (IQR 20-27). Scores were positively correlated. CONCLUSIONS: These uncontrolled observations (of mainly low to moderate quality and validity) do not allow confident assessment of the efficacy and safety of sugammadex for the reversal of NMBAs in patients with neuromuscular diseases. Reporting of observational data should follow established guidelines, include specific information to ensure validity, and emphasise what the new data add to current knowledge. SYSTEMATIC REVIEW PROTOCOL: PROSPERO 2019 (CRD42019119924).

2.
Br J Anaesth ; 2024 Jul 02.
Article in English | MEDLINE | ID: mdl-38960832

ABSTRACT

BACKGROUND: Perioperative myocardial injury after noncardiac surgery is associated with postoperative mortality. Heart rate (HR) is an independent risk factor for perioperative myocardial injury. In this pilot trial we tested the feasibility of a randomised, placebo-controlled trial of personalised HR-targeted perioperative ivabradine. METHODS: This was a single-centre, randomised, placebo-controlled, double-blind, parallel group, feasibility pilot trial conducted at Geneva University Hospitals. We included patients ≥75 yr old or ≥45 yr old with cardiovascular risk factors planned for intermediate- or high-risk surgery. Patients were randomised to receive ivabradine (2.5, 5.0, or 7.5 mg) or placebo according to their HR, twice daily, from the morning of surgery until postoperative day 2. Primary outcomes were appropriate dosage and blinding success rates. RESULTS: Between October 2020 and January 2022, we randomised 78 patients (recruitment rate of 1.3 patients week-1). Some 439 of 444 study drug administrations were adequate (99% appropriate dosage rate). The blinding success rate was 100%. There were 137 (31%) administrations of Pill A (placebo in both groups for HR ≤70 beats min-1). Nine (11.5%) patients had a high-sensitive cardiac troponin T elevation ≥14 ng L-1 between any two measurements. The number of bradycardia episodes was eight in the placebo group and nine in the ivabradine group. CONCLUSIONS: This pilot study demonstrates the feasibility of, and provides guidance for, a future trial testing the efficacy of personalised perioperative ivabradine. Future studies should include patients at higher risk of cardiac complications. CLINICAL TRIAL REGISTRATION: NCT04436016.

3.
New Microbiol ; 47(1): 28-32, 2024 May.
Article in English | MEDLINE | ID: mdl-38700880

ABSTRACT

Acute respiratory tract infections (ARI) are common diseases in children and adults and could cause severe infections in high-risk patients, like the immunocompromised and elderly, and are the leading cause of morbidity, hospitalization and mortality. This study aimed to explore the prevalence of respiratory viruses and the clinical impact of single- and multi-infection among hospitalized patients in various age groups. 3578 nasopharyngeal swabs (NPS) were analyzed for pathogen detection of acute respiratory tract infections. 930 out of 3578 NPS were diagnosed positive for at least one respiratory virus. The distribution of viral infections, prevalence and pathogen, differed significantly among age groups. Most RTI are observed in the age group over 65 years (50.6%) with a high SARS-CoV2 prevalence, following by group <5 years (25.6%), where the most frequently detected viruses were RSV, Rhinovirus, FluA-H3, MPV, and AdV. The co-infection rate also varies according to age and, in some cases, especially in older adults, could have severe clinical impact. This study emphasizes that it is important to know and analyze, in all age groups of hospitalized patients, the epidemiology of respiratory viruses, the prevalence of coinfections, and the clinical impact of various pathogens. Furthermore, in a clinical setting, the rapid diagnosis of respiratory infections by means of molecular tests is crucial not only to avoid hospital outbreaks, but also to allow early and optimal treatment to reduce morbidity and mortality.


Subject(s)
Coinfection , Respiratory Tract Infections , Humans , Respiratory Tract Infections/epidemiology , Respiratory Tract Infections/virology , Aged , Adult , Middle Aged , Child, Preschool , Adolescent , Child , Male , Young Adult , Female , Infant , Coinfection/epidemiology , Coinfection/virology , Aged, 80 and over , COVID-19/epidemiology , Prevalence , Hospitalization , SARS-CoV-2 , Virus Diseases/epidemiology , Virus Diseases/virology , Infant, Newborn , Pandemics , Viruses/isolation & purification , Viruses/classification , Viruses/genetics
4.
Crit Care Med ; 49(12): 2112-2120, 2021 12 01.
Article in English | MEDLINE | ID: mdl-34582409

ABSTRACT

OBJECTIVES: Sepsis is a common condition in the ICU. Despite much research, its prognosis remains poor. In 2017, a retrospective before/after study reported promising results using a combination of thiamine, ascorbic acid, and hydrocortisone called "metabolic resuscitation cocktail" and several randomized controlled trials assessing its effectiveness were performed. DESIGN: We conducted a systematic review and meta-analysis of randomized controlled trials in septic ICU patients to assess the effects of this combination therapy. SETTING: PubMed, Embase, and the Cochrane library databases were searched from inception to March of 2021. Data were extracted independently by two authors. The main outcome was the change in Sequential Organ Failure Assessment score within 72 hours. Secondary outcomes included renal composite endpoints (acute kidney injury) Kidney Disease - Improving Global Outcome organization stage 3 or need for renal replacement therapy, vasopressor duration, and 28-day mortality. SUBJECTS: We included randomized controlled trials with patients admitted to the ICU with sepsis or septic shock. INTERVENTION: The trials compared a combination of thiamine, ascorbic acid, and hydrocortisone to standard care or placebo in patients admitted to ICU with sepsis or septic shock. MEASUREMENTS AND MAIN RESULTS: We included eight randomized controlled trials (n = 1,335 patients). Within 72 hours, the median of mean improvement was -1.8 and -3.2 in the control and intervention groups, respectively (eight randomized controlled trials, n = 1,253 patients); weighted mean difference -0.82 (95% CI, -1.15 to -0.48). Data were homogeneous and the funnel plot did not suggest any publication bias. Duration of vasopressor requirement was significantly reduced in the intervention group (six randomized controlled trials). There was no evidence of a difference regarding the ICU mortality and the renal composite outcome (acute kidney injury KDIGO 3 or need for renal replacement therapy, seven randomized controlled trials). CONCLUSIONS: Metabolic resuscitation cocktail administrated in ICU septic patients improves change in Sequential Organ Failure Assessment score within 72 hours. However, this improvement is modest and its clinical relevance is questionable. The impact on renal failure and mortality remains unclear.


Subject(s)
Ascorbic Acid/metabolism , Hydrocortisone/metabolism , Metabolism/drug effects , Sepsis/drug therapy , Thiamine/metabolism , Ascorbic Acid/pharmacology , Ascorbic Acid/therapeutic use , Drug Combinations , Humans , Hydrocortisone/pharmacology , Hydrocortisone/therapeutic use , Ontario , Randomized Controlled Trials as Topic/statistics & numerical data , Sepsis/physiopathology , Thiamine/pharmacology , Thiamine/therapeutic use
5.
Palliat Med ; 35(8): 1407-1420, 2021 09.
Article in English | MEDLINE | ID: mdl-34109873

ABSTRACT

BACKGROUND: Providing unawareness and pain relief are core elements of palliative sedation. In addition to clinical scales, nociception and electroencephalogram-based depth of sedation monitoring are used to assess the level of consciousness and analgesia during sedation in intensive care units and during procedures. AIM: To determine whether reported devices impact the outcomes of palliative sedation. DESIGN: Systematic review and narrative synthesis of research published between January 2000 and December 2020. DATA SOURCES: Embase, Google Scholar, PubMed, CENTRAL, and the Cochrane Library. All reports describing the use of any monitoring device to assess the level of consciousness or analgesia during palliative sedation were screened for inclusion. Data concerning safety and efficacy were extracted. Patient comfort was the primary outcome of interest. Articles reporting sedation but that did not meet guidelines of the European Association for Palliative Care were excluded. RESULTS: Six reports of five studies were identified. Four of these were case series and two were case reports. Together, these six reports involved a total of 67 sedated adults. Methodological quality was assessed fair to good. Medication regimens were adjusted to bispectral index monitoring values in two studies, which found poor correlation between monitoring values and observational scores. In another study, high nociception index values, representing absence of pain, were used to detect opioid overdosing. Relatives and caregivers found the procedures feasible and acceptable.


Subject(s)
Analgesia , Anesthesia , Adult , Conscious Sedation , Humans , Hypnotics and Sedatives , Nociception , Palliative Care
6.
Paediatr Anaesth ; 31(11): 1194-1207, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34328688

ABSTRACT

BACKGROUND: Many pain scales are used post-operatively in pediatric trials, making the comparison of trials, and the pooling of data for meta-analyses difficult. The Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (PedIMMPACT) statement, published in 2008, attempted to address this issue. We aimed to investigate the reasons for authors' choice of pain scales and the potential impact of PedIMMPACT. METHODS: We performed a cross-sectional analysis of systematically searched randomized controlled trials testing tramadol in children (up to 16 years) undergoing surgery, published between 2000 and 2020 (9 years prior to and 12 years following the publication of PedIMMPACT). RESULTS: Among 76 trials (6211 children), 49 unique pain scales were used. The choice of the scales was explained in 18 trials (24%); in 13 of them, authors at least partly justified their choice by the fact that the pain scale was validated. In 52 trials (68%), the pain scales were referenced, with a total of 59 unique references, most often to prior studies using the same scale (36%) or to studies validating the chosen scale (31%). Twenty-three trials (30%) provided no explanation nor reference. One single trial referenced PedIMMPACT. There was no evidence of a change in the choice of pain scales after the publication of PedIMMPACT. CONCLUSIONS: A large variety of pain scales are still used in pediatric post-operative pain trials 12 years after the publication of PedIMMPACT. Only a minority of trials provided an explanation for their choice of pain scale. The reasons given most often included that the scale was validated or it was justified by a reference to a prior study using that scale. The impact of the publication of the PedIMMPACT seems limited. The ethics of the ongoing usage of large numbers of pain scales in pediatric pain trials must be challenged.


Subject(s)
Pain, Postoperative , Tramadol , Child , Cross-Sectional Studies , Humans , Pain Measurement , Pain, Postoperative/diagnosis , Pain, Postoperative/drug therapy , Randomized Controlled Trials as Topic
7.
Br J Anaesth ; 124(6): 726-738, 2020 06.
Article in English | MEDLINE | ID: mdl-32147100

ABSTRACT

BACKGROUND: Ivabradine lowers heart rate (HR) without affecting contractility or vascular tone. It is licensed for HR control in chronic heart diseases. We performed a systematic review and meta-analyses to examine whether ivabradine could decrease major adverse cardiovascular events (MACE) and mortality in critically ill patients. METHODS: We searched Medline, Embase, Cochrane Library, and Web of Science for RCTs. Trial quality was assessed using the Cochrane risk of bias tool. Random-effects meta-analyses were performed if at least three trials or 100 patients were available. Results are reported as weighted mean difference (WMD), odds ratio (OR), and 95% confidence intervals (CIs). Trial sequential analyses were performed to estimate the sample size needed to reach definitive conclusions of efficacy or futility. RESULTS: We included 13 RCTs (n=1497 patients). We found no evidence of an impact of ivabradine on MACE (three RCTs, 819 patients; OR=0.77; 95% CI, 0.53-1.11) or mortality (10 RCTs, 1356 patients; OR=1.07; 95% CI, 0.63-1.82), but sample sizes were not reached to allow definitive conclusions. Compared with placebo or standard care, ivabradine reduced HR (eight RCTs, 464 patients; WMD, -9.5 beats min-1; 95% CI, -13.3 to -5.8). Risk of bradycardia was not different between ivabradine and control (five RCTs, 434 patients; OR=1.2; 95% CI, 0.60-2.38). Risk of bias was overall high or unclear. CONCLUSIONS: Ivabradine reduces HR compared with placebo or standard care. The effect on MACE or mortality in acute care remains unclear. Further RCTs powered to detect changes in clinically relevant outcomes are warranted. CLINICAL TRIAL REGISTRATION: Prospero CRD42018086109.


Subject(s)
Cardiovascular Agents/therapeutic use , Heart Diseases/drug therapy , Heart Diseases/mortality , Ivabradine/therapeutic use , Critical Illness , Heart Diseases/physiopathology , Humans , Treatment Outcome
8.
Crit Care Med ; 46(10): 1665-1672, 2018 10.
Article in English | MEDLINE | ID: mdl-30080684

ABSTRACT

OBJECTIVES: To evaluate the performance of transcranial Doppler and transcranial color-coded duplex Doppler in patients with cerebral vasospasm due to aneurysm rupture. Angiography was considered as the gold standard comparator. DATA SOURCES: Search in MEDLINE, Embase, and Central from January 2001 to October 2017, without language restriction. Bibliographies of retrieved articles were screened for additional studies. STUDY SELECTION: Randomized studies comparing transcranial Doppler or transcranial color-coded duplex Doppler with angiography in adults. DATA EXTRACTION: Data were extracted independently by several investigators. Sensitivity and specificity were combined across studies using a bivariate model. Preferred Reporting Items for Systematic Reviews and Meta-Analyses was used for reporting and Quality Assessment of Diagnostic Accuracy Studies-2 for quality assessment. DATA SYNTHESIS: We included 18 studies. Fifteen tested transcranial Doppler. For the middle cerebral artery (10 studies, 1,408 tests), the pooled sensitivity was 66.7% (95% CI, 55.9-75.9) and specificity was 89.5% (80.3-94.7). Three studies (278 tests) tested transcranial color-coded duplex Doppler for the middle cerebral artery. The pooled sensitivity was 81.5% (66.0-90.0), and specificity was 96.6% (93.0-98.0). For an arbitrarily chosen prevalence of vasospasm of 70%, positive and negative predictive values were 93.7% (88.9-96.6) and 53.4% (46.7-60.9) for transcranial Doppler and 98.2% (96.4-99.1) and 69.1% (56.1-80.9) for transcranial color-coded duplex Doppler. CONCLUSIONS: Assuming a high prevalence of vasospasm of the middle cerebral artery, both transcranial Doppler and transcranial color-coded duplex Doppler are likely to detect it, but neither is useful to exclude it. There is no convincing evidence that the accuracy of transcranial color-coded duplex Doppler is any better than that of transcranial Doppler. For arteries other than middle cerebral artery, there is a lack of evidence of the usefulness of transcranial Doppler.


Subject(s)
Infarction, Middle Cerebral Artery/diagnostic imaging , Ultrasonography, Doppler, Color/methods , Ultrasonography, Doppler, Transcranial/methods , Vasoconstriction , Vasospasm, Intracranial/diagnostic imaging , Blood Flow Velocity , Female , Humans , Male , Middle Cerebral Artery/diagnostic imaging
9.
Anesth Analg ; 127(1): 228-239, 2018 07.
Article in English | MEDLINE | ID: mdl-29782398

ABSTRACT

BACKGROUND: This systematic review examines the benefit and harm of adding epinephrine to local anesthetics for epidural, intrathecal, or locoregional anesthesia. METHODS: We searched electronic databases to October 2017 for randomized trials comparing any local anesthetic regimen combined with epinephrine, with the same local anesthetic regimen without epinephrine, reporting on duration of analgesia, time to 2 segments regression, or any adverse effects. Trial quality was assessed using the Cochrane risk of bias tool and a random-effects model was used. Trial sequential analyses (TSA) were applied to identify the information size (IS; number of patients needed to reach a definite conclusion) and were set to detect an increase or decrease of effect of 30%-50%, depending on the end point considered. Alpha levels were adjusted (1%) for multiple outcome testing. RESULTS: We identified 70 trials (3644 patients, 17 countries, from 1970 to 2017). Median number of patients per trial was 44 (range, 9-174). Thirty-seven trials (1781 patients) tested epinephrine for epidural, 27 (1660) for intrathecal, and 6 (203) for locoregional anesthesia (sciatic, femoral, popliteal, axillary blocks). TSA enabled us to conclude that adding epinephrine to epidural local anesthetics could not decrease postoperative pain intensity by 30%, and did not impact the risk of intraoperative arterial hypotension. IS was insufficient to conclude on the impact of epinephrine on the risk of motor block (IS, 4%), arterial hypotension (20%), urinary retention (23%), or pain intensity at rest (27%) during labor. TSA confirmed that adding epinephrine to intrathecal local anesthetics increased the duration of motor block (weighted mean difference [WMD] 64 minutes; 99% CI, 37-91), analgesia (WMD 34 minutes; 99% CI, 6-62), and the time to 2 segments regression (WMD 20 minutes; 99% CI, 11-28). IS was insufficient to conclude on its impact on arterial hypotension (IS, 15%), or when administrated in a combined spinal-epidural, on motor block (IS, 11%) or arterial hypotension (IS, 11%). Adding epinephrine to local anesthetics for a locoregional block increased the duration of analgesia (WMD 66 minutes; 98% CI, 32-100]). CONCLUSIONS: Adding epinephrine to intrathecal or locoregional local anesthetics prolongs analgesia and motor block by no more than 60 minutes. The impact of adding epinephrine to epidural local anesthetics or to a combined spinal-epidural remains uncertain.


Subject(s)
Analgesia, Obstetrical/methods , Anesthesia, Obstetrical/methods , Anesthesia, Spinal/methods , Anesthetics, Local/administration & dosage , Epinephrine/administration & dosage , Nerve Block/methods , Analgesia, Obstetrical/adverse effects , Anesthesia, Obstetrical/adverse effects , Anesthesia, Spinal/adverse effects , Anesthetics, Local/adverse effects , Epinephrine/adverse effects , Female , Humans , Male , Motor Activity/drug effects , Nerve Block/adverse effects , Pain Threshold/drug effects , Pregnancy , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
10.
Anesth Analg ; 127(4): 873-880, 2018 10.
Article in English | MEDLINE | ID: mdl-29750696

ABSTRACT

BACKGROUND: Sedation with propofol is frequently used to facilitate diagnostic and therapeutic procedures. Propofol can be administrated by the patient (patient-controlled sedation [PCS]) or by a clinician (clinician-controlled sedation [CCS]). We aimed to compare these 2 techniques. METHODS: PubMed, Embase, CENTRAL, and trial registries were searched up to October 2017 for randomized controlled trials comparing PCS with CCS with propofol. The primary end points were the risks of presenting at least 1 episode of oxygen desaturation, arterial hypotension, and bradycardia, and the risk of requiring a rescue intervention (pharmacologic therapies or physical maneuvers) for sedation-related adverse events. Secondary end points were the dose of propofol administrated, operator and patient satisfaction, and the risk of oversedation. A random-effects model and an α level of .02 to adjust for multiple analyses were used throughout. Trial sequential analyses were performed for primary outcomes. Quality of evidence was assessed according to the Grades of Recommendation, Assessment, Development, and Evaluation system. RESULTS: Thirteen trials (1103 patients; median age, 47 years; American Society of Anesthesiologists physical status I-III) describing various diagnostic and therapeutic procedures with propofol sedation were included. PCS had no impact on the risk of oxygen desaturation (11 trials, 31/448 patients [6.9%] with PCS versus 46/481 [9.6%] with CCS; risk ratio, 0.74 [98% confidence interval, 0.35-1.56]) but decreased the risk of requiring a rescue intervention for adverse events (11 trials, 29/449 patients [6.5%] with PCS versus 74/482 [15.4%] with CCS; risk ratio, 0.45 [98% confidence interval, 0.25-0.81]). For both outcomes, Trial sequential analyses suggested that further trials were unlikely to change the results, although the quality of evidence was graded very low for all primary outcomes. For the risk of arterial hypotension and bradycardia, the required sample size for a definitive conclusion had not been reached. Analysis of secondary outcomes suggested that PCS decreased the risk of oversedation and had no impact on propofol dose administrated, or on operator or patient satisfaction. CONCLUSIONS: PCS with propofol, compared with CCS with propofol, had no impact on the risk of oxygen desaturation, but significantly decreased the risk of rescue interventions for sedation-related adverse events. Further high-quality trials are required to assess the risks and benefits of PCS.


Subject(s)
Anesthetics, Intravenous/administration & dosage , Conscious Sedation/methods , Consciousness/drug effects , Hypnotics and Sedatives/administration & dosage , Propofol/administration & dosage , Adult , Aged , Anesthetics, Intravenous/adverse effects , Clinical Trials as Topic , Conscious Sedation/adverse effects , Drug Administration Schedule , Female , Humans , Hypnotics and Sedatives/adverse effects , Male , Middle Aged , Patient Satisfaction , Propofol/adverse effects , Risk Assessment , Risk Factors , Self Administration
11.
BMC Public Health ; 18(1): 583, 2018 05 02.
Article in English | MEDLINE | ID: mdl-29720146

ABSTRACT

BACKGROUND: In Cameroon, the National Tuberculosis Control Program that applies selective directly observed treatments faces difficulties in its implementation for a lack of resources, leading to only 65% of patients with sputum smear-positive pulmonary tuberculosis being cured after 6 months of treatment. This study aimed to evaluate the effectiveness of daily Short Message Service reminders to increase adherence and the proportion of adult tuberculosis patients cured after 6 months of treatment. METHODS: A simple blinded, randomised controlled, multicentre study carried out in 12 Treatment and Diagnostic Centres of Yaoundé. The patients included were randomly assigned to two groups: patients in the intervention group received daily SMS reminders in addition to the usual treatment; those in the control group received the usual treatment only. The primary outcomes were the number and proportion of treatment success at 5 months, and the number and proportion of patients cured at 6 months. Data analysis was by intention to treat. RESULTS: Two hundred and seventy-nine participants were randomized into intervention group (n = 137) and control group (n = 142). At five months, there were 111 treatment success (81%) in the intervention group and 106 (74.6%) in the control group (OR = 1.45 [0.81, 2.56]; p = 0.203). At 6 months, there were 87 patients cured (63.5%) in the intervention group and 88 (62%) in the control group (OR = 1.06 [0.65, 1.73]; p = 0.791). The number of drop-outs at 6 months was 47 (34.3%) in intervention group, and 46 (32.4%) in the control group. 48.9% (23/47) and 39.1% (18/46) of these drop-outs were sputum-negative at 5 months. At three different appointments, there were no significant differences between the two groups in any secondary outcomes. Very high and similar satisfaction was found for general management of patients in both groups: 99.5 and 99.2% (p = 0.41). CONCLUSIONS: Our study suggests that SMS reminders do not increase treatment success and cure proportions. However, the low proportion of patients cured at 6 month may be an underestimation due to a high dropout rate between the fifth and the sixth months of treatment. Future trials should focus on reducing the dropout rate. TRIAL REGISTRATION: The trial was registered on the Pan-African Clinical Trials Registry ( PACTR201307000583416 of 22 July 2013) and the protocol was published.


Subject(s)
Medication Adherence/statistics & numerical data , Reminder Systems , Text Messaging , Tuberculosis/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , Cameroon , Female , Humans , Male , Middle Aged , Young Adult
12.
BMC Med Ethics ; 19(1): 57, 2018 06 08.
Article in English | MEDLINE | ID: mdl-29884170

ABSTRACT

BACKGROUND: Since 2010, the European Journal of Anaesthesiology has required the reporting of five items concerning ethical approval in articles describing human research: ethics committee's name and address, chairperson's name, study's protocol number and approval date. We aimed to assess whether this requirement has helped to identify and to contact the referenced ethics committees. METHODS: In this cross-sectional study, we analysed articles requiring ethical approval, according to the Swiss federal law for human research and published in the European Journal of Anaesthesiology in 2011. Ethics committees were searched through our institutional Internet access based on information provided in the articles. The last search was performed in November 2015. Numbers (%) of items reported, of ethics committees identified, and of those that confirmed having provided ethical approval are reported. RESULTS: Of 76 articles requiring ethical approval, 74 (97%) declared it. Ethics committees' names and addresses were mentioned in 63/74 (85%), protocol numbers in 51/74 (69%), approval dates in 48/74 (65%), and chairpersons' names in 45/74 (61%). We could identify 44/74 (59%) committees; 36/74 (49%) answered our inquiry and 24/74 (32%) confirmed their role. Thirty-four of 74 articles (46%) reported all five items; in 25/34 (74%), we were able to identify an ethics committee, 18/34 (53%) answered our inquiry, and 15/34 (44%) confirmed their role. Forty of 74 articles (54%) reported ≤4 items; in 19/40 (48%), we were able to identify an ethics committee, 18/40 (45%) answered our inquiry, and 9/40 (23%) confirmed their role. Reporting five items significantly increased identification of ethics committees (p = 0.023) and their confirmation of ethical approval (p = 0.048). Twelve of 74 ethics committees (16%) were unable to confirm their role in approving the study. CONCLUSIONS: Even when details concerning ethical approval were reported in these studies of human research, we were unable to identify almost half of the ethics committees concerned. The reporting of five items, compared with reporting ≤4, was associated with facilitated identification of ethics committees, and increased the likelihood that they would be able to confirm the study's approval. Future research should identify which information facilitates identification of, and contact with, ethics committees.


Subject(s)
Disclosure , Ethical Review , Ethics Committees, Research , Ethics, Research , Publishing/ethics , Research , Social Control, Formal/methods , Anesthesiology , Authorship , Committee Membership , Cross-Sectional Studies , Editorial Policies , Europe , Humans , Periodicals as Topic/ethics , Records , Surveys and Questionnaires , Switzerland
13.
Health Qual Life Outcomes ; 13: 12, 2015 Feb 04.
Article in English | MEDLINE | ID: mdl-25649467

ABSTRACT

BACKGROUND: Changes in health-related quality of life (HRQoL) several days after surgery have rarely been investigated. We aimed to estimate the perioperative change of HRQoL, to identify patients with clinically relevant decrease in postoperative HRQoL and to establish factors associated with this decrease in HRQoL at day 30 after major surgery. METHODS: Patients scheduled for major surgery at a university hospital were enrolled. Based on the HRQoL SF-12 questionnaire, the preoperative physical component summary (PCS) score, preoperative mental component summary (MCS) score, and postoperative PCS and MCS scores at day 30 were recorded. Minimal clinically important difference (MCID) was defined as those with a decrease of at least one half of the standard deviation (SD) of preoperative PCS or MCS scores. Differences between the groups with or without decreased HRQoL were investigated using univariate comparisons. A multiple logistic regression model was performed to evaluate the predictive value of potential perioperative variables. RESULTS: The mean ± SD preoperative PCS score was 38.5 ± 10.6, postoperative score was 35.1 ± 7.8 (p = .004) in 85 patients. Thirty-five patients (41.2%) had a clinically relevant decrease of the postoperative PCS score. A normal to high preoperative exercise metabolic capacity measured with metabolic equivalent of task (MET) (p = .01) was a predictor of the decrease in postoperative PCS. The mean preoperative MCS scores (p = .395) were 42.2 (SD 12.8) preoperative, and 43.45 (SD 12.4) postoperative, respectively. CONCLUSIONS: Major surgery decreases postoperative PCS scores of HRQoL at 30 days. A normal to high exercise capacity was a predictor of a clinically relevant decrease of postoperative PCS scores. TRIAL REGISTRATION: 07-107 (Ethical Committee NAC of Geneva University Hospitals).


Subject(s)
General Surgery/statistics & numerical data , Pain, Postoperative/psychology , Postoperative Complications/psychology , Quality of Life/psychology , Aged , Cohort Studies , Female , Humans , Logistic Models , Male , Middle Aged , Models, Psychological , Models, Statistical , Outcome Assessment, Health Care , Postoperative Period , Preoperative Period , Prospective Studies , Surveys and Questionnaires , Switzerland
14.
Ann Surg ; 259(6): 1056-67, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24096762

ABSTRACT

OBJECTIVE: To quantify benefit and harm of epidural analgesia, compared with systemic opioid analgesia, in adults having surgery under general anesthesia. BACKGROUND: It remains controversial whether adding epidural analgesia to general anesthesia decreases postoperative morbidity and mortality. METHODS: We searched CENTRAL, EMBASE, PubMed, CINAHL, and BIOSIS till July 2012. We included randomized controlled trials comparing epidural analgesia (with local anesthetics, lasting for ≥ 24 hours postoperatively) with systemic analgesia in adults having surgery under general anesthesia, and reporting on mortality or any morbidity endpoint. RESULTS: A total of 125 trials (9044 patients, 4525 received epidural analgesia) were eligible. In 10 trials (2201 patients; 87 deaths), reporting on mortality as a primary or secondary endpoint, the risk of death was decreased with epidural analgesia (3.1% vs 4.9%; odds ratio, 0.60; 95% confidence interval, 0.39-0.93). Epidural analgesia significantly decreased the risk of atrial fibrillation, supraventricular tachycardia, deep vein thrombosis, respiratory depression, atelectasis, pneumonia, ileus, and postoperative nausea and vomiting, and also improved recovery of bowel function, but significantly increased the risk of arterial hypotension, pruritus, urinary retention, and motor blockade. Technical failures occurred in 6.1% of patients. CONCLUSIONS: In adults having surgery under general anesthesia, concomitant epidural analgesia reduces postoperative mortality and improves a multitude of cardiovascular, respiratory, and gastrointestinal morbidity endpoints compared with patients receiving systemic analgesia. Because adverse effects and technical failures cannot be ruled out, individual risk-benefit analyses and professional care are recommended.


Subject(s)
Analgesia, Epidural/methods , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Randomized Controlled Trials as Topic , Adult , Global Health , Humans , Morbidity/trends , Prognosis , Surgical Procedures, Operative , Survival Rate/trends
16.
Anesthesiology ; 121(1): 59-67, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24608361

ABSTRACT

BACKGROUND: Magnesium enhances the effect of rocuronium. Sugammadex reverses rocuronium-induced neuromuscular block. The authors investigated whether magnesium decreased the efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular block. METHODS: Thirty-two male patients were randomized in a double-blinded manner to receive magnesium sulfate (MgSO4) 60 mg/kg or placebo intravenously before induction of anesthesia with propofol, sufentanil, and rocuronium 0.6 mg/kg. Neuromuscular transmission was monitored using TOF-Watch SX acceleromyography (Organon Ltd., Dublin, Ireland). In 16 patients, sugammadex 2 mg/kg was administered intravenously at reappearance of the second twitch of the train-of-four (moderate block). In 16 further patients, sugammadex 4 mg/kg was administered intravenously at posttetanic count 1 to 2 (deep block). Primary endpoint was recovery time from injection of sugammadex to normalized train-of-four ratio 0.9. Secondary endpoint was recovery time to final T1. RESULTS: Average time for reversal of moderate block was 1.69 min (SD, 0.81) in patients pretreated with MgSO4 and 1.76 min (1.13) in those pretreated with placebo (P = 0.897). Average time for reversal of deep block was 1.77 min (0.83) in patients pretreated with MgSO4 and 1.98 min (0.58) in those pretreated with placebo (P = 0.572). Times to final T1 were longer compared with times to normalized train-of-four ratio 0.9, without any difference between patients pretreated with MgSO4 or placebo. CONCLUSION: Pretreatment with a single intravenous dose of MgSO4 60 mg/kg does not decrease the efficacy of recommended doses of sugammadex for the reversal of a moderate and deep neuromuscular block induced by an intubation dose of rocuronium.


Subject(s)
Androstanols/antagonists & inhibitors , Magnesium Sulfate/pharmacology , Neuromuscular Blockade , Neuromuscular Nondepolarizing Agents/antagonists & inhibitors , gamma-Cyclodextrins/pharmacology , Adolescent , Adult , Androstanols/adverse effects , Anesthesia Recovery Period , Double-Blind Method , Endpoint Determination , Female , Humans , Injections, Intravenous , Magnesium Sulfate/administration & dosage , Magnesium Sulfate/adverse effects , Male , Middle Aged , Monitoring, Intraoperative , Neuromuscular Blockade/adverse effects , Neuromuscular Nondepolarizing Agents/adverse effects , Preanesthetic Medication , Rocuronium , Sugammadex , Young Adult , gamma-Cyclodextrins/adverse effects
17.
Eur J Anaesthesiol ; 36(11): 805-806, 2019 11.
Article in English | MEDLINE | ID: mdl-31580285

Subject(s)
Publishing
18.
Anesthesiology ; 119(2): 303-16, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23719611

ABSTRACT

BACKGROUND: Intraoperative high inspired oxygen fraction (FIO2) is thought to reduce the incidence of surgical site infection (SSI) and postoperative nausea and vomiting, and to promote postoperative atelectasis. METHODS: The authors searched for randomized trials (till September 2012) comparing intraoperative high with normal FIO2 in adults undergoing surgery with general anesthesia and reporting on SSI, nausea or vomiting, or pulmonary outcomes. RESULTS: The authors included 22 trials (7,001 patients) published in 26 reports. High FIO2 ranged from 80 to 100% (median, 80%); normal FIO2 ranged from 30 to 40% (median, 30%). In nine trials (5,103 patients, most received prophylactic antibiotics), the incidence of SSI decreased from 14.1% with normal FIO2 to 11.4% with high FIO2; risk ratio, 0.77 (95% CI, 0.59-1.00). After colorectal surgery, the incidence of SSI decreased from 19.3 to 15.2%; risk ratio, 0.78 (95% CI, 0.60-1.02). In 11 trials (2,293 patients), the incidence of nausea decreased from 24.8% with normal FIO2 to 19.5% with high FIO2; risk ratio, 0.79 (95% CI, 0.66-0.93). In patients receiving inhalational anesthetics without prophylactic antiemetics, high FIO2 provided a significant protective effect against both nausea and vomiting. Nine trials (3,698 patients) reported on pulmonary outcomes. The risk of atelectasis was not increased with high FIO2. CONCLUSIONS: Intraoperative high FIO2 further decreases the risk of SSI in surgical patients receiving prophylactic antibiotics, has a weak beneficial effect on nausea, and does not increase the risk of postoperative atelectasis.


Subject(s)
Lung/physiology , Oxygen Inhalation Therapy/methods , Oxygen/therapeutic use , Postoperative Nausea and Vomiting/prevention & control , Surgical Wound Infection/prevention & control , Humans , Intraoperative Period
19.
Exp Clin Endocrinol Diabetes ; 131(6): 338-344, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37015329

ABSTRACT

BACKGROUND: Hyperglycaemia is associated with worse outcomes in many settings. However, the association between dysglycaemia and adverse outcomes remains debated in COVID-19 patients. This study determined the association of prehospital blood glucose levels with acute medical unit (intensive care unit or high dependency unit) admission and mortality among COVID-19-infected patients. METHODS: This was a single-centre, retrospective cohort study based on patients cared for by the prehospital medical mobile unit from a Swiss university hospital between March 2020 and April 2021. All adult patients with confirmed or suspected COVID-19 infection during the study period were included. Data were obtained from the prehospital medical files. The main exposure was prehospital blood glucose level. A 7.8 mmol/L cut-off was used to define high blood glucose level. Restricted cubic splines were also used to analyse the exposure as a continuous variable. The primary endpoint was acute medical unit admission; secondary endpoints were 7-day and 30-day mortality. Multivariable logistic regressions were performed to compute odds ratios. RESULTS: A total of 276 patients were included. The mean prehospital blood glucose level was 8.8 mmol/l, and 123 patients presented high blood glucose levels. The overall acute medical unit admission rate was 31.2%, with no statistically significant difference according to prehospital blood glucose levels. The mortality rate was 13.8% at 7 days and 25% at 30 days. The 30-day mortality rate was higher in patients with high prehospital blood glucose levels, with an adjusted odds ratio of 2.5 (1.3-4.8). CONCLUSIONS: In patients with acute COVID-19 infection, prehospital blood glucose levels do not seem to be associated with acute medical unit admission. However, there was an increased risk of 30-day mortality in COVID-19 patients who presented high prehospital blood glucose levels.


Subject(s)
COVID-19 , Emergency Medical Services , Hyperglycemia , Adult , Humans , COVID-19/complications , Blood Glucose/analysis , Retrospective Studies , Hyperglycemia/epidemiology
20.
J Patient Rep Outcomes ; 7(1): 5, 2023 01 25.
Article in English | MEDLINE | ID: mdl-36695927

ABSTRACT

BACKGROUND: Decision-making concerning relatives undergoing surgery is challenging. It remains unclear to what extent implicated next of kin eventually regret their decisions and how this regret is assessed. Our aim was to systematically review the literature on decisional regret of next of kin and to describe the assessment tools used and the surgical populations studied. METHODS: We included interventional or observational, quantitative or qualitative studies reporting the measurement of decisional regret of next of kin concerning relatives undergoing surgery. We searched a variety of databases without restriction on publication year. We assessed the quality of reporting of quantitative studies using the NIH Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies and of qualitative studies using the Critical Appraisal Skills Program Checklist. RESULTS: Thirteen cross-sectional, five prospective cohorts and five qualitative studies matched our inclusion criteria. In 18 studies (78%), patients were children, in five (22%), young or middle-aged adults. No study included elderly or frail patients. Thirteen studies (57%) used the original Decision Regret Scale which was validated for patients, but not for next of kin. Only 3 of the 18 (17%) quantitative studies and only one of the 4 (25%) qualitative studies were rated as "good" in the quality assessment. CONCLUSION: None of the retrieved studies used validated tools to assess the decisional regret of next of kin and none of them examined this issue in elderly or frail surgical patients.


Subject(s)
Decision Making , Emotions , Adult , Aged , Middle Aged , Child , Humans , Cross-Sectional Studies , Prospective Studies
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