RESUMEN
Importance: The effect of oral midazolam premedication on patient satisfaction in older patients undergoing surgery is unclear, despite its widespread use. Objective: To determine the differences in global perioperative satisfaction in patients with preoperative administration of oral midazolam compared with placebo. Design, Setting, and Participants: This double-blind, parallel-group, placebo-controlled randomized clinical trial was conducted in 9 German hospitals between October 2017 and May 2019 (last follow-up, June 24, 2019). Eligible patients aged 65 to 80 years who were scheduled for elective inpatient surgery for at least 30 minutes under general anesthesia and with planned extubation were enrolled. Data were analyzed from November 2019 to December 2020. Interventions: Patients were randomized to receive oral midazolam, 3.75 mg (n = 309), or placebo (n = 307) 30 to 45 minutes prior to anesthesia induction. Main Outcomes and Measures: The primary outcome was global patient satisfaction evaluated using the self-reported Evaluation du Vécu de l'Anesthésie Generale (EVAN-G) questionnaire on the first postoperative day. Key secondary outcomes included sensitivity and subgroup analyses of the primary outcome, perioperative patient vital data, adverse events, serious complications, and cognitive and functional recovery up to 30 days postoperatively. Results: Among 616 randomized patients, 607 were included in the primary analysis. Of these, 377 (62.1%) were male, and the mean (SD) age was 71.9 (4.4) years. The mean (SD) global index of patient satisfaction did not differ between the midazolam and placebo groups (69.5 [10.7] vs 69.6 [10.8], respectively; mean difference, -0.2; 95% CI, -1.9 to 1.6; P = .85). Sensitivity (per-protocol population, multiple imputation) and subgroup analyses (anxiety, frailty, sex, and previous surgical experience) did not alter the primary results. Secondary outcomes did not differ, except for a higher proportion of patients with hypertension (systolic blood pressure ≥160 mm Hg) at anesthesia induction in the placebo group. Conclusion and Relevance: A single low dose of oral midazolam premedication did not alter the global perioperative patient satisfaction of older patients undergoing surgery or that of patients with anxiety. These results may be affected by the low dose of oral midazolam. Further trials-including a wider population with commonplace low-dose intravenous midazolam and plasma level measurements-are needed. Trial Registration: ClinicalTrials.gov Identifier: NCT03052660.
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Midazolam , Satisfacción del Paciente , Anciano , Humanos , Masculino , Femenino , Midazolam/administración & dosificación , Midazolam/efectos adversos , Método Doble Ciego , Anestesia General , Satisfacción Personal , Atención Dirigida al PacienteRESUMEN
BACKGROUND: Avoidance of airway complications and rapid emergence from anaesthesia are indispensable for the use of a laryngeal mask airway (LMA). Evidence from adequately powered randomised studies with a low risk of bias for the optimal anaesthetic in this context is limited. OBJECTIVE: We tested the hypothesis that when using remifentanil-based intra-operative analgesia, desflurane would be the most suitable anaesthetic: with noninferiority in the occurrence of upper airway complications and superiority in emergence times compared with sevoflurane or propofol. DESIGN: A randomised, multicentre, partially double-blinded, three-arm, parallel-group study. SETTING: Two university and two regional German hospitals, from February to October 2015. PATIENTS: A total of 352 patients (age 18 to 75 years, ASA physical status I to III, BMI less than 35âkgâm and fluent in German) were enrolled in this study. All surgery was elective with a duration of 0.5 to 2âh, and general anaesthesia with a LMA was feasible. INTERVENTION: The patients were randomised to receive desflurane, sevoflurane or propofol anaesthesia. MAIN OUTCOME MEASURES: This study was powered for the primary outcome 'time to state date of birth' and the secondary outcome 'intra-operative cough'. Time to emergence from anaesthesia and the incidence of upper airway complications were assessed on the day of surgery. RESULTS: The primary outcome was analysed for 343 patients: desflurane (n=114), sevoflurane (n=111) and propofol (n=118). The desflurane group had the fastest emergence. The mean (± SD) times to state the date of birth following desflurane, sevoflurane and propofol were 8.1â±â3.6, 10.1â±â4.0 and 9.8â±â5.1âmin, respectively (Pâ<â0.01). There was no difference in upper airway complications (cough and laryngospasm) across the groups, but these complications were less frequent than in previous studies. CONCLUSION: When using a remifentanil infusion for intra-operative analgesia in association with a LMA, desflurane was associated with a significantly faster emergence and noninferiority in the incidence of intra-operative cough than either sevoflurane or Propofol. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02322502; EudraCT identifier: 2014-003810-96.
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Analgésicos Opioides/administración & dosificación , Periodo de Recuperación de la Anestesia , Anestesia General/tendencias , Anestésicos por Inhalación/administración & dosificación , Máscaras Laríngeas/tendencias , Remifentanilo/administración & dosificación , Adulto , Retraso en el Despertar Posanestésico/diagnóstico , Retraso en el Despertar Posanestésico/prevención & control , Desflurano/administración & dosificación , Método Doble Ciego , Procedimientos Quirúrgicos Electivos/tendencias , Femenino , Humanos , Isoflurano/administración & dosificación , Masculino , Persona de Mediana Edad , Propofol/administración & dosificaciónRESUMEN
BACKGROUND: Quantitative neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologists, however, use insensitive, qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this multicentre, prospective, double-blinded, assessor controlled study was to develop an algorithm of muscle function tests to identify PORC. METHODS: After extubation a blinded anesthetist performed eight clinical tests in 165 patients. Test results were correlated to calibrated electromyography train-of-four (TOF) ratio and to a postoperatively applied uncalibrated acceleromyography. A classification and regression tree (CART) was calculated developing the algorithm to identify PORC. This was validated against uncalibrated acceleromyography and tactile judgement of TOF fading in separate 100 patients. RESULTS: After eliminating three tests with poor correlation, a model with four tests (r = 0.844) and uncalibrated acceleromyography (r = 0.873) were correlated to electromyographical TOF-values without losing quality of prediction. CART analysis showed that three consecutively performed tests (arm lift, head lift and swallowing or eye opening) can predict electromyographical TOF. Prediction coefficients reveal an advantage of the uncalibrated acceleromyography in terms of specificity to identify the EMG measured train-of-four ratio < 0.7 (100% vs. 42.9%) and <0.9 (89.7% vs. 34.5%) compared to the algorithm. However, due to the high sensitivity of the algorithm (100% vs. 94.4%), the risk to overlook an awake patient with a train-of-four ratio < 0.7 was minimal. Tactile judgement of TOF fading showed poorest sensitivity and specifity at train of four ratio < 0.9 (33.7%, 0%) and <0.7 (18.8%, 16.7%). CONCLUSIONS: Residual neuromuscular blockade can be detected by uncalibrated acceleromyography and if not available by a pathway of four clinical muscle function tests in awake patients. The algorithm has a discriminative power comparable to uncalibrated AMG within TOF-values >0.7 and <0.3. TRIAL REGISTRATION: Clinical Trials.gov (principal investigator's name: CU, and identifier: NCT03219138) on July 8, 2017.
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Algoritmos , Retraso en el Despertar Posanestésico/prevención & control , Valor Predictivo de las Pruebas , Adolescente , Adulto , Anciano , Método Doble Ciego , Electromiografía , Femenino , Humanos , Cinetocardiografía , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
BACKGROUND AND AIMS: The ProSeal™ laryngeal mask airway (PLMA) has a soft cuff which tends to fold on itself during insertion, resulting in reduced first-attempt success rate. We compared the standard introducer technique of PLMA insertion with a novel method to prevent folding of the cuff using a Rüsch™ Stylet. METHODS: This randomised superiority trial included 120 American Society of Anesthesiologists I-II patients between 18 and 80 years, undergoing elective surgeries under general anaesthesia using a PLMA for airway management. The PLMA was inserted using the standard introducer tool in sixty patients (Group IT), while in sixty other patients, a Rüsch™ Stylet was inserted through the drain tube up to its tip. (Group ST). The primary outcome was first-attempt success rate. Secondary outcomes included overall insertion success, number of attempts, total time to successful insertion, presence of air leaks, haemodynamic response to insertion and quality of fit assessed using Brimacombe's fibre-optic scoring. Continuous variables were compared using independent t-test or Mann-Whitney U-test and categorical variables were analysed using Chi-square test or Fisher's exact test. RESULTS: First-attempt success rate of insertion was higher in Group ST compared to Group IT (95% vs. 82%, P = 0.04). Favourable grade of placement was better in Group ST (86.7% vs. 52.5%, P < 0.001). Overall insertion success rates and haemodynamic responses were comparable between the groups. CONCLUSIONS: PLMA insertion using the stylet tool has a higher first-attempt insertion success and superior placement compared to insertion using the conventional introducer tool.
RESUMEN
BACKGROUND: The use of a laryngeal mask airway (LMA) in appropriate patients supports fast-track anesthesia with a lower incidence of postoperative airway-connected adverse events. Data on the most favorable anesthetic in this context, with the lowest rate of upper airway complications and fast emergence times, are controversial and limited. Desflurane seems to match these criteria best, but large randomized controlled trials (RCTs) with a standardized study protocol are lacking. Therefore, we aim to compare desflurane with other commonly used anesthetics, sevoflurane and propofol, in a sufficiently powered RCT. We hypothesize that desflurane is noninferior regarding the frequency of upper airway events and superior regarding the emergence times to sevoflurane and propofol. METHODS/DESIGN: A total of 351 patients undergoing surgery with an LMA will be included in this prospective, randomized, double-blind controlled, multicenter clinical trial. The patients will be randomly assigned to the three treatment arms: desflurane (n = 117), sevoflurane (n = 117), and propofol (n = 117). The emergence time (time to state the date of birth) will be the primary endpoint of this study. The secondary endpoints include further emergence times, such as time to open eyes, to remove LMA, to respond to command and to state name. Additionally, we will determine the frequency of cough and laryngospasm, measured intraoperatively and at emergence. We will assess the postoperative recovery on the first postoperative day via the Postoperative Quality Recovery Scale. DISCUSSION: Despite increasing importance of cost-effective and safe anesthesia application, we lack proof for the most advantageous anesthetic agent, when an LMA is used. There are only a few RCTs comparing desflurane to other commonly used anesthetics (sevoflurane, propofol and isoflurane) in patients with LMA. These RCTs were conducted with small sample sizes, huge interstudy variability, and some also showed strong biases. The present multicenter RCT will provide results from a large sample size with a standardized study protocol and minimized bias, which is feasible in the clinical routine. Furthermore, we will expand our knowledge regarding the most favorable recovery on the first postoperative day, which impacts patients' comfort after surgery. TRIAL REGISTRATION: EudraCT Identifier: 2014-003810-96, 5 September 2014 ClinicalTrials.gov: NCT02322502, December 2014.
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Periodo de Recuperación de la Anestesia , Anestesia General/instrumentación , Anestesia por Inhalación/instrumentación , Anestésicos por Inhalación/administración & dosificación , Anestésicos Intravenosos/administración & dosificación , Isoflurano/análogos & derivados , Máscaras Laríngeas , Éteres Metílicos/administración & dosificación , Propofol/administración & dosificación , Anestesia General/efectos adversos , Anestesia General/métodos , Anestesia por Inhalación/efectos adversos , Anestesia por Inhalación/métodos , Anestésicos por Inhalación/efectos adversos , Anestésicos Intravenosos/efectos adversos , Protocolos Clínicos , Estado de Conciencia/efectos de los fármacos , Desflurano , Método Doble Ciego , Alemania , Humanos , Isoflurano/administración & dosificación , Isoflurano/efectos adversos , Éteres Metílicos/efectos adversos , Complicaciones Posoperatorias/etiología , Propofol/efectos adversos , Estudios Prospectivos , Recuperación de la Función , Proyectos de Investigación , Factores de Riesgo , Sevoflurano , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE OF REVIEW: Sugammadex is a new reversal agent with a unique mechanism of action in anaesthesia. Because of its rapid onset of action and its efficacy in determining neuromuscular blockade at any time, it opens up new perspectives in anaesthesia. RECENT FINDINGS: During the last few years, a lot of phase II and III studies have been published, investigating various groups of patients and clinical situations. Sugammadex has been shown to be a well tolerated drug, which appears to meet every challenge it is presented with in daily clinical practice. SUMMARY: Sugammadex binds amino-steroidal muscle relaxants by encapsulation. It enables rapid reversal of neuromuscular blockade at any time point and at any depth of block. Its effects are predictable and very reliable, in contrast to cholinesterase inhibitors. This opens up new perspectives in anaesthesia. Even an emergency reversal of high-dose rocuronium-induced neuromuscular blockade is possible with sugammadex and times to full recovery (TOF 0.9) are faster than after spontaneous recovery from suxamethonium.
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Anestesia , Relajantes Musculares Centrales/antagonistas & inhibidores , gamma-Ciclodextrinas/farmacología , Androstanoles/antagonistas & inhibidores , Animales , Interacciones Farmacológicas , Servicios Médicos de Urgencia , Humanos , Fármacos Neuromusculares no Despolarizantes/antagonistas & inhibidores , Rocuronio , Sugammadex , Bromuro de Vecuronio/antagonistas & inhibidores , gamma-Ciclodextrinas/administración & dosificación , gamma-Ciclodextrinas/efectos adversos , gamma-Ciclodextrinas/farmacocinéticaRESUMEN
Cyclodextrins consist of rings of sugar molecules with a lipophilic core and a hydrophilic periphery. Thus they are well soluble in water and possess the ability to bind (encapsulate) steroid molecules. Cyclodextrins have now been modified (sugammadex) in such a way a perfect complex formation with rocuronium results. In this way an alternative to the classical indirect antagonists has been discovered. It is now possible to terminate a neuromuscular blockade via an intravasal encapsulation of rocuronium far distant from the neuromuscular endplates and avoiding the side effects associated with acetylcholinestase inhibitors instead of by an intervention in the acetylcholine system. Furthermore, it has been found that even deep neuromuscular blockades can be reversed within 2 minutes by means of this novel mechanism.
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Bloqueantes Neuromusculares/antagonistas & inhibidores , gamma-Ciclodextrinas/uso terapéutico , Androstanoles/química , Androstanoles/uso terapéutico , Humanos , Riñón/efectos de los fármacos , Riñón/fisiología , Modelos Moleculares , Relajación Muscular/efectos de los fármacos , Relajación Muscular/fisiología , Fármacos Neuromusculares no Despolarizantes/química , Rocuronio , Sugammadex , gamma-Ciclodextrinas/químicaRESUMEN
BACKGROUND: Sugammadex (Org 25969), a novel, selective relaxant binding agent, was specifically designed to rapidly reverse rocuronium-induced neuromuscular blockade. The efficacy and safety of sugammadex for the reversal of profound, high-dose rocuronium-induced neuromuscular blockade was evaluated. METHODS: A total of 176 adult patients were randomly assigned to receive sugammadex (2, 4, 8, 12, or 16 mg/kg) or placebo at 3 or 15 min after high-dose rocuronium (1.0 or 1.2 mg/kg) during propofol anesthesia. The primary endpoint was time to recovery of the train-of-four ratio to 0.9. Neuromuscular monitoring was performed using acceleromyography. RESULTS: Sugammadex administered 3 or 15 min after injection of 1 mg/kg rocuronium decreased the median recovery time of the train-of-four ratio to 0.9 in a dose-dependent manner from 111.1 min and 91.0 min (placebo) to 1.6 min and 0.9 min (16 mg/kg sugammadex), respectively. After 1.2 mg/kg rocuronium, sugammadex decreased time to recovery of train-of-four from 124.3 min (3-min group) and 94.2 min (15-min group) to 1.3 min and 1.9 min with 16 mg/kg sugammadex, respectively. There was no clinical evidence of reoccurrence of neuromuscular blockade or residual neuromuscular blockade. Exploratory analysis revealed that prolongation of the corrected QT interval considered as possibly related to sugammadex occurred in one patient. Another two patients developed markedly abnormal arterial blood pressure after sugammadex that lasted approximately 15 min. CONCLUSION: Sugammadex provides a rapid and dose-dependent reversal of profound neuromuscular blockade induced by high-dose rocuronium (1.0 or 1.2 mg/kg) in adult surgical patients.
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Androstanoles/antagonistas & inhibidores , Androstanoles/farmacología , Fármacos Neuromusculares Despolarizantes/farmacología , gamma-Ciclodextrinas/farmacología , Androstanoles/administración & dosificación , Anestesia Intravenosa , Anestésicos Intravenosos , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Bloqueo Neuromuscular , Fármacos Neuromusculares Despolarizantes/administración & dosificación , Fármacos Neuromusculares Despolarizantes/antagonistas & inhibidores , Propofol , Rocuronio , Sugammadex , gamma-Ciclodextrinas/administración & dosificación , gamma-Ciclodextrinas/efectos adversosRESUMEN
UNLABELLED: Breathing 100% oxygen at the end of general anesthesia has been shown to worsen postoperative pulmonary gas exchange when an endotracheal tube is used. Counter measures, such as high positive end-expiratory pressure or the vital-capacity maneuver, may limit this effect. Such strategies, however, may be impracticable, or even contraindicated, when the laryngeal mask airway (LMA) is used. Because of the vast differences in design between the LMA and endotracheal tube, we examined postanesthetic blood gas tensions in patients after emergence from anesthesia breathing oxygen via LMA. Sixty-four ASA physical status I-II patients undergoing general anesthesia for 60 min with LMA were randomly assigned to receive either 100% or 30% oxygen during emergence from anesthesia and removal of LMA. Postoperative blood gas measurements were taken at 30 and 60 min after removal of the LMA. At either measurement, patients treated with 100% oxygen essentially had the same arterial partial pressure of oxygen (60-min measurement: 83 +/- 8 versus 85 +/- 7 mm Hg [mean +/- SD], P = 0.14) as those treated with 30% oxygen. We conclude that breathing 100% oxygen at the end of general anesthesia does not worsen postoperative pulmonary gas exchange when an LMA is used. IMPLICATIONS: The endotracheal tube and laryngeal mask airway are substantially different artificial airways used to ventilate the lungs of anesthetized patients. Breathing 100% oxygen before removing the endotracheal tube results in lung function defects. This study shows that oxygen breathing before removing the laryngeal mask airway has no effect on pulmonary function.