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2.
Paediatr Drugs ; 23(1): 11-37, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33108649

RESUMEN

Postoperative nausea and vomiting (PONV), postoperative vomiting (POV), post-discharge nausea and vomiting (PDNV), and opioid-induced nausea and vomiting (OINV) continue to be causes of pediatric morbidity, delay in discharge, and unplanned hospital admission. Research on the pathophysiology, risk assessment, and therapy for PDNV, OINV and pain therapy options in children has received increased attention. Multimodal pain management with the use of perioperative regional and opioid-sparing analgesia has helped decrease nausea and vomiting. Two common emetogenic surgical procedures in children are adenotonsillectomy and strabismus repair. Although PONV risk factors differ between adults and children, the approach to decrease baseline risk is similar. As PONV and POV are frequent in children, antiemetic prophylaxis should be considered for those at risk. A multimodal approach for antiemetic and pain therapy involves preoperative risk evaluation and stratification, antiemetic prophylaxis, and pain management with opioid-sparing medications and regional anesthesia. Useful antiemetics include dexamethasone and serotonin 5-hydroxytryptamine-3 (5-HT3) receptor antagonists such as ondansetron. Multimodal combination prophylactic therapy using two or three antiemetics from different drug classes and propofol total intravenous anesthesia should be considered for children at high PONV risk. "Enhanced recovery after surgery" protocols include a multimodal approach with preoperative preparation, adequate intravenous fluid hydration, opioid-sparing analgesia, and prophylactic antiemetics. PONV guidelines and management algorithms help provide effective postoperative care for pediatric patients.


Asunto(s)
Antieméticos/uso terapéutico , Náusea y Vómito Posoperatorios/etiología , Náusea y Vómito Posoperatorios/terapia , Niño , Preescolar , Femenino , Humanos , Incidencia , Masculino , Náusea y Vómito Posoperatorios/fisiopatología
3.
Anesth Analg ; 131(2): 411-448, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32467512

RESUMEN

This consensus statement presents a comprehensive and evidence-based set of guidelines for the care of postoperative nausea and vomiting (PONV) in both adult and pediatric populations. The guidelines are established by an international panel of experts under the auspices of the American Society of Enhanced Recovery and Society for Ambulatory Anesthesia based on a comprehensive search and review of literature up to September 2019. The guidelines provide recommendation on identifying high-risk patients, managing baseline PONV risks, choices for prophylaxis, and rescue treatment of PONV as well as recommendations for the institutional implementation of a PONV protocol. In addition, the current guidelines focus on the evidence for newer drugs (eg, second-generation 5-hydroxytryptamine 3 [5-HT3] receptor antagonists, neurokinin 1 (NK1) receptor antagonists, and dopamine antagonists), discussion regarding the use of general multimodal PONV prophylaxis, and PONV management as part of enhanced recovery pathways. This set of guidelines have been endorsed by 23 professional societies and organizations from different disciplines (Appendix 1).Guidelines currently available include the 3 iterations of the consensus guideline we previously published, which was last updated 6 years ago; a guideline published by American Society of Health System Pharmacists in 1999; a brief discussion on PONV management as part of a comprehensive postoperative care guidelines; focused guidelines published by the Society of Obstetricians and Gynecologists of Canada, the Association of Paediatric Anaesthetists of Great Britain & Ireland and the Association of Perianesthesia Nursing; and several guidelines published in other languages.The current guideline was developed to provide perioperative practitioners with a comprehensive and up-to-date, evidence-based guidance on the risk stratification, prevention, and treatment of PONV in both adults and children. The guideline also provides guidance on the management of PONV within enhanced recovery pathways.The previous consensus guideline was published 6 years ago with a literature search updated to October 2011. Several guidelines, which have been published since, are either limited to a specific populations or do not address all aspects of PONV management. The current guideline was developed based on a systematic review of the literature published up through September 2019. This includes recent studies of newer pharmacological agents such as the second-generation 5-hydroxytryptamine 3 (5-HT3) receptor antagonists, a dopamine antagonist, neurokinin 1 (NK1) receptor antagonists as well as several novel combination therapies. In addition, it also contains an evidence-based discussion on the management of PONV in enhanced recovery pathways. We have also discussed the implementation of a general multimodal PONV prophylaxis in all at-risk surgical patients based on the consensus of the expert panel.


Asunto(s)
Consenso , Manejo de la Enfermedad , Náusea y Vómito Posoperatorios/terapia , Guías de Práctica Clínica como Asunto/normas , Acetaminofén/administración & dosificación , Administración Intravenosa , Analgésicos no Narcóticos/administración & dosificación , Antieméticos/administración & dosificación , Humanos , Náusea y Vómito Posoperatorios/diagnóstico
4.
J Burn Care Res ; 41(2): 322-327, 2020 02 19.
Artículo en Inglés | MEDLINE | ID: mdl-31541245

RESUMEN

The management of pain and sedation during burn dressing change is challenging. Previous reviews and studies have identified wide variability in such practices in hospitalized burn patients. This survey-based study aimed to determine the most commonly utilized sedation and analgesia practices in adult burn patients treated in the outpatient setting. The goal was to identify opportunities for improvement and to assist burn centers in optimizing sedation procedures. A 23-question survey was sent to members of the American Burn Association. Nonpharmacological interventions including music, television, games, and virtual reality were used by 68% of survey respondents. Eighty-one percent reported premedicating with oral opioids, 32% with intravenous opioids, and 45% with anxiolytics. Fifty-nine percentage of respondents indicated that the initial medication regimen for outpatient dressing changes consisted of the patient's existing oral pain medications. Forty-three percent indicated that there were no additional options if this regimen provided inadequate analgesia. Fifty-six percentage of respondents felt that pain during dressing change was adequately controlled 75% to 100% of the time, and 32% felt it was adequately controlled 50% to 75% of the time. Nitrous oxide was used by 8%. Anesthesia providers and an acute pain service are available in a minority of cases (13.7% and 28%, respectively) and are rarely consulted. Procedural burn pain remains significantly undertreated in the outpatient setting and the approach to treatment is variable among burn centers in the United States. Such variation likely represents an opportunity for identifying and implementing optimal practices and developing guidelines for burn pain management in the outpatient setting.


Asunto(s)
Atención Ambulatoria , Analgesia/métodos , Vendajes , Quemaduras/terapia , Sedación Consciente , Manejo del Dolor/métodos , Analgésicos Opioides/uso terapéutico , Ansiolíticos/uso terapéutico , Antibacterianos/uso terapéutico , Femenino , Humanos , Masculino , Óxido Nitroso/uso terapéutico , Terapia por Relajación , Encuestas y Cuestionarios
5.
J Anesth Hist ; 5(4): 115-125, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31735276

RESUMEN

Horst Otto Stoeckel was born September 26, 1930, in Lodz, Poland, which was part of the newly founded Second Republic of Poland until it was occupied by Nazi Germany in 1939. After World War II, his family immigrated to Meiningen, Germany, where he obtained his primary and secondary education. He attended Humboldt University and the University Hospital Charité of Berlin for his medical degree. Profs Theodor Brugsch, Karl Lohmann, and Friedrich Dost were important individuals who helped develop his interest in quantitative clinical pharmacology and pharmacokinetics. Prior to anesthesiology, Stoeckel trained in surgery, internal medicine, and obstetrics and gynecology in addition to clinical anesthesiology at a community hospital in East Germany. He completed 2 years of obligatory training to become an anesthesia specialist at the Teaching Hospital Hufeland and the Research Institute for Lung Diseases at Berlin-Buch. He also received training in anesthesia at the Humboldt University of Berlin. After escaping East Berlin through the Brandenburg Gate in August 1961, he obtained a position at the University of Heidelberg and obtained his West German board certification in anesthesiology in 1962. In the following 12-year period, Stoeckel was married, was promoted, passed his "habilitation" or lectureship period, started a family, and was granted the title of "Professor." His administrative career began in February 1974 when he was selected as the first Chair of Anesthesiology at the University of Bonn, a position he held for 22 years. He also served as Dean of the medical school from 1980 to 1981. As Chair, he developed three areas: patient care, teaching, and research. He developed a long-term research program in the field of "Quantitative Clinical Pharmacology in Anesthesia and the Quantitative Modeling and Control in Anesthesia," which required an interdisciplinary team of specialists in biochemistry, physics, and modern analytical methods. Over 20 years, the group's research program led to the discovery of basic algorithms providing the foundation of the automatic regulation of dosing control by the closed-loop feedback system, which is a concept important to the target-controlled infusion of intravenous and inhalation anesthetics. Following his career as a clinician, administrator, and researcher, he pursued a second career as a collector and museum founder.


Asunto(s)
Anestesiología/historia , Investigación Biomédica/historia , Personal Administrativo/historia , Distinciones y Premios , Alemania Occidental , Historia del Siglo XX , Polonia , Facultades de Medicina/historia , Facultades de Medicina/organización & administración
6.
J Anesth Hist ; 5(4): 126-137, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31735277

RESUMEN

As a medical student and during his preacademic time prior to 1958, Horst Stoeckel was interested in the history of medicine and especially history related to anesthesia. After his retirement from Chair of Anesthesiology at the University of Bonn in 1994, Stoeckel received a gift from Professor Richard Kitz of Harvard University (Boston, MA) that encouraged him to develop his collection of 150 artifacts and 350 books and periodicals into a scientific museum and library. The late librarian, Patrick P. Sim, MLS, of the Wood Library-Museum of Anesthesiology in the United States also encouraged and supported Stoeckel with literature concerning anesthesia history. The Horst Stoeckel Museum of Anaesthesiology (Horst-Stoeckel-Museum fur die Geschichte der Anasthesiologie) was dedicated by the University of Bonn and opened to the public on October 9, 2000, and currently has more than 1000 items displayed in 45 themed display cases. A newly themed concept of Incremental Development of Eminent Anesthesia Landmarks to Operational Routine was developed for the display and explanation of the history of anesthesia related to pioneers, equipment, books, and manuscripts. A display concept combining Person, Publication, and Apparatus is used throughout the museum. A well-stocked library currently holds more than 13,000 books and periodicals. The museum's 10-year anniversary was celebrated with a symposium entitled "German Pioneers in Anaesthesia of the first 100 years," held at the University of Bonn on October 8, 2010. The museum's Web site in German, English, and French is www.anaesthesia-museum.uni-bonn.de.


Asunto(s)
Anestesiología/historia , Bibliotecas Médicas/historia , Museos/historia , Anestesiología/instrumentación , Equipos y Suministros/historia , Alemania Occidental , Historia del Siglo XX , Historia del Siglo XXI , Universidades
7.
J Burn Care Res ; 40(3): 287-293, 2019 04 26.
Artículo en Inglés | MEDLINE | ID: mdl-30844056

RESUMEN

Sedation practices for pediatric burn patients during dressing changes vary between institutions and providers. To better understand the current trends in pediatric sedation practice, a survey was conducted among the members of the American Burn Association (ABA). Questions asked about nonoperating room sedation and analgesia practices for burn patients (ages 0-17) having dressing changes in the intensive care unit, inpatient unit, and outpatient clinics. ABA members providing sedation for pediatric patients undergoing burn dressing changes are diverse. Physician respondents included surgeons, critical care intensivists, and anesthesiologists. Others included physician assistants, nurse anesthetists, nurse practitioners, and sedation credentialed nurses. Opioids for pain control were prescribed by 100% of respondents, but use of adjuvant nonopioid analgesics was utilized <50% of the time. Benzodiazepines and ketamine were prescribed more than twice as often as other sedatives. Many noted that up to 50% of children did not have adequately controlled anxiety and pain with initial sedation plans, and escalation of care was needed to complete dressing changes. Self-reported adverse events were infrequent. In outpatient settings, benzodiazepines, ketamine, oral opioids, and topical lidocaine were used frequently, as were nonpharmacologic methods of distraction and comfort. Sedation in pediatric burn patients is challenging. Responses highlighted areas for improvement regarding pain control during dressing changes and increasing use of multimodal analgesia. Commonly used medications including opioids, benzodiazepine, and ketamine are well established in the treatment of burn patients, as are nonpharmacologic methods. A collaborative effort among institutions is needed to formulate practice guidelines for sedation during burn dressing changes.


Asunto(s)
Analgésicos/uso terapéutico , Quemaduras/terapia , Sedación Consciente/métodos , Hipnóticos y Sedantes/uso terapéutico , Manejo del Dolor/métodos , Encuestas y Cuestionarios , Adolescente , Unidades de Quemados , Quemaduras/diagnóstico , Niño , Preescolar , Cuidados Críticos/métodos , Femenino , Humanos , Lactante , Masculino , Dimensión del Dolor , Pediatría , Medición de Riesgo , Sociedades Médicas , Estados Unidos
9.
Reg Anesth Pain Med ; 43(4): 446-447, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29668657

Asunto(s)
Procaína
10.
Anesthesiology ; 128(6): 1099-1106, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29543631

RESUMEN

BACKGROUND: Postoperative nausea and vomiting causes distress for patients and can prolong care requirements. Consensus guidelines recommend use of multiple antiemetics from different mechanistic classes as prophylaxis in patients at high risk of postoperative nausea and vomiting. The prophylactic efficacy of the dopamine D2/D3 antagonist amisulpride in combination with other antiemetics was investigated. METHODS: This double-blind, randomized, placebo-controlled, international, multicenter trial was conducted in 1,147 adult surgical patients having three or four postoperative nausea and vomiting risk factors. Patients were randomized to receive either intravenous amisulpride (5 mg) or matching placebo at induction of general anesthesia, in addition to one standard, nondopaminergic antiemetic, most commonly ondansetron or dexamethasone. Vomiting/retching, nausea, and use of rescue medication were recorded for 24 h after wound closure. The primary endpoint was complete response, defined as no emesis or rescue medication use in the 24-h postoperative period. RESULTS: Complete response occurred in 330 of 572 (57.7%) of the amisulpride group and 268 of 575 (46.6%) of the control group (difference 11.1 percentage points; 95% CI, 5.3 to 16.8; P < 0.001). The incidences of emesis (13.8% vs. 20.0%, P = 0.003), any nausea (50.0% vs. 58.3%, P = 0.002), significant nausea (37.1% vs. 47.7%, P < 0.001), and rescue medication use (40.9% vs. 49.4%, P = 0.002) were significantly lower in the amisulpride group. Adverse events and laboratory and electrocardiogram abnormalities occurred no more frequently with amisulpride than with placebo. CONCLUSIONS: Intravenous amisulpride was safe and effective as prophylaxis of postoperative nausea and vomiting when given in combination with an antiemetic from another class to adult patients at high risk for suffering postoperative nausea and vomiting undergoing elective surgery under inhalational general anesthesia. VISUAL ABSTRACT: An online visual overview is available for this article at http://links.lww.com/ALN/B727.


Asunto(s)
Amisulprida/administración & dosificación , Anestesia General/efectos adversos , Antagonistas de Dopamina/administración & dosificación , Internacionalidad , Náusea y Vómito Posoperatorios/inducido químicamente , Náusea y Vómito Posoperatorios/prevención & control , Administración Intravenosa , Adulto , Anestesia General/tendencias , Antipsicóticos/administración & dosificación , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Náusea y Vómito Posoperatorios/diagnóstico , Factores de Riesgo
11.
Reg Anesth Pain Med ; 42(6): 760-763, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28953509

RESUMEN

In 1924, the Therapeutic Research Committee of the American Medical Association appointed a special committee to investigate deaths following the administration of local anesthetics. The Committee for the Study of Toxic Effects of Local Anesthetics found procaine, although a safer clinical alternative to cocaine, was capable of causing death when large doses were injected into tissues and advised that it should be used with caution. This article describes a collaboration beginning in 1928 between Dr John Lundy of the Mayo Clinic and Dr Robert Isenberger of the University of Kansas, which arose from a controversy surrounding systemic adverse reactions to procaine. Isenberger then traveled to the Mayo Clinic to conduct research on various procaine local and spinal anesthesia doses and sodium amytal's protective effect against procaine-induced toxicity. Lundy and Isenberger's work would add to the ongoing discovery of systemic reactions to local anesthetics.


Asunto(s)
Anestesia Local/historia , Anestésicos Locales/historia , Investigación Biomédica/historia , Colaboración Intersectorial , Procaína/historia , Anestesia Local/efectos adversos , Anestésicos Locales/efectos adversos , Historia del Siglo XX , Humanos , Procaína/efectos adversos
12.
Anesthesiology ; 126(2): 268-275, 2017 02.
Artículo en Inglés | MEDLINE | ID: mdl-27902493

RESUMEN

BACKGROUND: Two essentially identical, randomized, double-blind, placebo-controlled, parallel-group phase III studies evaluated the efficacy of intravenous amisulpride, a dopamine D2/D3 antagonist, in the prevention of postoperative nausea and vomiting in adult surgical patients. METHODS: Adult inpatients undergoing elective surgery during general anesthesia and having at least two of the four Apfel risk factors for postoperative nausea and vomiting were enrolled at 9 U.S. and 10 European sites. A single 5-mg dose of amisulpride or matching placebo was given at induction of anesthesia. The primary endpoint was complete response, defined as no vomiting/retching and no use of antiemetic rescue medication in the 24-h postoperative period. Nausea incidence was a secondary endpoint. RESULTS: Across the two studies, 689 patients were randomized and dosed with study medication, of whom 626 were evaluable per protocol. In the U.S. study, 46.9% (95% CI, 39.0 to 54.9) of patients achieved complete response in the amisulpride group compared to 33.8% (95% CI, 26.2 to 42.0) in the placebo group (P = 0.026). In the European study, complete response rates were 57.4% (95% CI, 49.2 to 65.3) for amisulpride and 46.6% (95% CI, 38.8 to 54.6) for placebo (P = 0.070). Nausea occurred less often in patients who received amisulpride than those who received placebo. There was no clinically significant difference in the safety profile of amisulpride and placebo; in particular, there were no differences in terms of QT prolongation, extrapyramidal side effects, or sedation. CONCLUSIONS: One of the two trials demonstrated superiority, while pooling both in a post hoc change to the plan of analysis supported the hypothesis that amisulpride was safe and superior to placebo in reducing the incidence of postoperative nausea and vomiting in a population of adult inpatients at moderate to high risk of postoperative nausea and vomiting.


Asunto(s)
Antagonistas de Dopamina/uso terapéutico , Náusea y Vómito Posoperatorios/prevención & control , Sulpirida/análogos & derivados , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Amisulprida , Antagonistas de Dopamina/administración & dosificación , Método Doble Ciego , Femenino , Humanos , Inyecciones Intravenosas , Masculino , Persona de Mediana Edad , Sulpirida/administración & dosificación , Sulpirida/uso terapéutico , Resultado del Tratamiento , Adulto Joven
13.
Drugs ; 76(18): 1719-1735, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-27988869

RESUMEN

Since the introduction of the serotonin 5-hydroxy tryptamine 3 (5-HT3) receptor antagonists in the early 1990s, the incidence of postoperative nausea and vomiting (PONV) and post-discharge nausea and vomiting (PDNV) has decreased, yet continues to be a problem for the surgical patient. The clinical application of the 5-HT3 receptor antagonists has helped define the approach and role of these antiemetics in the prevention and treatment of PONV and PDNV. Pharmacological and clinical differences exist among these medications resulting in corresponding differences in effectiveness, safety, optimal dosage, time of administration, and use as combination and rescue antiemetic therapy. The clinical application of the 5-HT3 receptor antagonist antiemetics has improved the prevention and treatment of PONV and PDNV. The most recent consensus guidelines for PONV published in 2014 outline the use of these antiemetics. The 5-HT3 receptor antagonists play an important role to help prevent PONV and PDNV in perioperative care pathways such as Enhanced Recovery After Surgery (ERAS). Comparisons and guidelines for use of the 5-HT3 receptor antagonists in relation to the risk for PONV and PDNV are reviewed.


Asunto(s)
Antieméticos/uso terapéutico , Náusea y Vómito Posoperatorios/tratamiento farmacológico , Receptores de Serotonina 5-HT3/metabolismo , Antagonistas del Receptor de Serotonina 5-HT3/uso terapéutico , Serotonina/metabolismo , Humanos
14.
J Anesth Hist ; 1(1): 25-9, 2015 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-25748370

RESUMEN

Walter S. Sutton (1877-1916) was a physician, scientist, and inventor. Most of the work on Sutton has focused on his recognition that chromosomes carry genetic material and are the basis for Mendelian inheritance. Perhaps less well known is his work on rectal administration of ether. After Sutton's work on genetics, he completed his medical degree in 1907 and began a 2-year surgical fellowship at Roosevelt Hospital, New York City, NY, where he was introduced to the technique of rectal administration of ether. Sutton modified the work of others and documented 100 cases that were reported in his 1910 landmark paper "Anaesthesia by Colonic Absorption of Ether". Sutton had several deaths in his study, but he did not blame the rectal method. He felt that his use of rectal anesthesia was safe when administered appropriately and believed that it offered a distinct advantage over traditional pulmonary ether administration. His indications for its use included (1) head and neck surgery; (2) operations when ether absorption must be minimized due to heart, lung, or kidney problems; and (3) preoperative pulmonary complications. His contraindications included (1) cases involving alimentary tract or weakened colon; (2) laparotomies, except when the peritoneal cavity was not opened; (3) incompetent sphincter or anal fistula; (4) orthopnea; and (5) emergency cases. Sutton wrote the chapter on "Rectal Anesthesia" in one of the first comprehensive textbooks in anesthesia, James Tayloe Gwathmey's Anesthesia. Walter Sutton died of a ruptured appendix in 1916 at age 39.

15.
J Anesth Hist ; 1(3): 85-6, 2015 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-26930082
16.
Drugs ; 73(14): 1525-47, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-24057415

RESUMEN

New antiemetic drug developments, formulations, guidelines, risk evaluation, and controversies have occurred in the area of postoperative nausea and vomiting (PONV). These developments have helped improve our understanding of the prevention and treatment of PONV in the postanesthesia care unit and after discharge home or to the hospital ward. Antiemetic drug research has resulted in the introduction of the second-generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist palonosetron and the neurokinin-1 (NK-1) receptor antagonist aprepitant, as well as new data on existing antiemetics. The next frontier and need for further nausea and vomiting research and therapy is the area of postdischarge nausea and vomiting after the patient is discharged home from phase II of the ambulatory stepdown unit or to the hospital ward. Antiemetic drug selection depends on efficacy, cost, safety, and ease of dosing. Safety concerns have arisen regarding the side effects of antiemetics, specifically their effect on the ECG with prolongation of the QTc interval by the butyrophenones and the first-generation 5-HT3 receptor antagonist class of antiemetics. The impact of pharmocogenetics on antiemetic drug metabolism and their resulting efficacy has been correlated with genetic makeup affecting drug response. A discussion of ethics in PONV research has been initiated by the meta-analysis of PONV studies. To help guide antiemetic selection and PONV therapy for clinical practitioners, the Society of Ambulatory Anesthesia (SAMBA) PONV consensus guidelines have been introduced and updated.


Asunto(s)
Antieméticos/uso terapéutico , Antagonistas del Receptor de Neuroquinina-1/uso terapéutico , Náusea y Vómito Posoperatorios/tratamiento farmacológico , Antagonistas del Receptor de Serotonina 5-HT3/uso terapéutico , Humanos , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos
17.
Anesthesiology ; 114(2): 318-29, 2011 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-21239968

RESUMEN

BACKGROUND: The management of elderly patients can be challenging for anesthesiologists for many reasons, including altered pharmacokinetics and dynamics. This study compared the efficacy, safety, and pharmacokinetics of sugammadex for moderate rocuronium-induced neuromuscular blockade reversal in adult (aged 18-64 yr) versus elderly adult (aged 65 yr or older) patients. METHODS: This phase 3a, multicenter, parallel-group, comparative, open-label study enrolled 162 patients aged 18 yr and older, American Society of Anesthesiologists class 1-3, scheduled for surgery with general anesthesia and requiring neuromuscular blockade. After anesthesia induction, patients received rocuronium, 0.6 mg/kg, before tracheal intubation, with maintenance doses of 0.15 mg/kg as required. At the end of surgery, patients received sugammadex, 2.0 mg/kg, at reappearance of the second twitch of the train-of-four (TOF) for reversal. The primary efficacy variable was time from sugammadex administration to recovery of the TOF ratio to 0.9 or greater. Pharmacokinetics and safety were also evaluated. RESULTS: Overall, 150 patients were treated and had at least one postbaseline efficacy assessment; 48 were aged 18-64 yr (adult), 62 were aged 65-74 yr (elderly), and 40 were aged 75 yr or older (old-elderly). The geometric mean time (95% confidence interval) from sugammadex administration to recovery of the TOF ratio to 0.9 increased with age, from 2.3 (2.0-2.6) min (adults) to 2.9 (2.7-3.2) min (elderly/old-elderly groups combined). Recovery of the TOF ratio to 0.9 was estimated to be 0.7 min faster in adults compared with patients aged 65 yr or older (P = 0.022). Sugammadex was well tolerated by all patients. CONCLUSION: Sugammadex facilitates rapid reversal from moderate rocuronium-induced neuromuscular blockade in adults of all ages.


Asunto(s)
Androstanoles/antagonistas & inhibidores , Anestesia General , Bloqueo Neuromuscular , Fármacos Neuromusculares no Despolarizantes/antagonistas & inhibidores , gamma-Ciclodextrinas/farmacología , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Análisis de Varianza , Periodo de Recuperación de la Anestesia , Relación Dosis-Respuesta a Droga , Femenino , Evaluación Geriátrica/métodos , Evaluación Geriátrica/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/inducido químicamente , Rocuronio , Sugammadex , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven , gamma-Ciclodextrinas/efectos adversos , gamma-Ciclodextrinas/farmacocinética
18.
J Clin Anesth ; 21(6): 444-53, 2009 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-19833281

RESUMEN

Sugammadex is a novel cyclodextrin, the first in a new class of selective binding reversal agents that terminates neuromuscular block (NMB) with the steroidal nondepolarizing agents, rocuronium and vecuronium. Sugammadex can reverse a moderate or deep NMB. The dose required depends on the level of NMB that needs to be reversed. Smaller doses are sufficient for a moderate versus deep NMB. In October 2007, a new drug application for sugammadex was submitted to the U.S. Food and Drug Administration (FDA). The FDA issued a not-approvable letter in July 2008. The manufacturer continues clinical trials.


Asunto(s)
Bloqueo Neuromuscular/métodos , Fármacos Neuromusculares no Despolarizantes/antagonistas & inhibidores , gamma-Ciclodextrinas/farmacología , Androstanoles/farmacología , Animales , Ensayos Clínicos como Asunto , Relación Dosis-Respuesta a Droga , Humanos , Fármacos Neuromusculares no Despolarizantes/farmacología , Rocuronio , Sugammadex , Bromuro de Vecuronio/farmacología , gamma-Ciclodextrinas/administración & dosificación
19.
Anesth Analg ; 108(5): 1498-504, 2009 May.
Artículo en Inglés | MEDLINE | ID: mdl-19372328

RESUMEN

BACKGROUND: Postoperative nausea and vomiting (PONV) are common complications after ambulatory surgery. We sought to determine whether the use of transdermal scopolamine (TDS) in combination with IV ondansetron (OND) is more effective than one alone for reducing PONV in outpatient settings. METHODS: In a randomized, double blind, multicenter trial, 620 at-risk female patients undergoing outpatient laparoscopic or breast augmentation surgery received either an active TDS patch or a similar appearing sham 2 h before entering the operating room. All patients received IV OND (4 mg) 2-5 min before induction of anesthesia followed by a general anesthetic regimen. Complete antiemetic response, defined as no vomiting/retching or rescue medication use, was measured through 24 h and 48 h after surgery. The proportion of patients with vomiting/retching, nausea, or use of rescue medication, the time from the end of surgery to the first episode of these events and the time to discharge from the hospital/surgery center, as well as the number and severity of vomiting/retching and nausea episodes, and patient satisfaction with antiemetic therapy were also collected. RESULTS: The combination of TDS + OND statistically significantly reduced nausea and vomiting/retching compared with OND alone 24 h after surgery but not at 48 h. The proportion of patients who did not experience vomiting/retching and did not use rescue medication was 48% for TDS + OND and 39% for OND alone (P < 0.02). Total response (no nausea, no vomiting/retching, and no use of rescue medication) was also statistically higher for the TDS + OND group compared with the OND-only group (35% vs 25%, P < 0.01). The time to first nausea, vomiting/retching, or rescue episode was statistically significantly longer for the TDS + OND group compared with the OND-only group (P < 0.05). The cumulative overall incidence of adverse events was lower in the TDS + OND group compared with the OND group (36.7% vs 49%, P < 0.01). CONCLUSIONS: TDS + OND reduces PONV compared with OND alone. This is achieved with a reduction in adverse events.


Asunto(s)
Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Antieméticos/administración & dosificación , Ondansetrón/administración & dosificación , Náusea y Vómito Posoperatorios/prevención & control , Escopolamina/administración & dosificación , Administración Cutánea , Adulto , Antieméticos/efectos adversos , Colecistectomía Laparoscópica/efectos adversos , Método Doble Ciego , Quimioterapia Combinada , Femenino , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Humanos , Inyecciones Intravenosas , Laparoscopía/efectos adversos , Tiempo de Internación , Mamoplastia/efectos adversos , Persona de Mediana Edad , Ondansetrón/efectos adversos , Satisfacción del Paciente , Náusea y Vómito Posoperatorios/etiología , Escopolamina/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos
20.
Anesth Analg ; 107(2): 439-44, 2008 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-18633021

RESUMEN

BACKGROUND: We designed this multicenter, randomized, double-blind study to assess the efficacy and safety of three doses of palonosetron, compared with placebo, on the incidence and severity of postoperative nausea and vomiting (PONV) in inpatients for 72 h after surgery. METHODS: Female patients undergoing either elective gynecological or breast surgery were stratified according to two additional PONV risk factors: nonsmoking status and history of PONV and/or motion sickness. Five hundred forty-four patients with one or both of these risk factors were randomized to receive one of the three doses of IV palonosetron (0.025 mg, 0.050 mg, 0.075 mg) or placebo immediately before induction of anesthesia. The primary efficacy end-point was complete response (CR: no emesis and no use of rescue medications) evaluated at the 0-24 and 24-72 h time intervals after surgery. RESULTS: CR rates for placebo and palonosetron 0.075 mg were 36% and 56% for 0-24 h (P = 0.001), 52% and 70% for 24-72 h (P = 0.002) and 36% and 52% (P = 0.010) for the 0-72 h postoperative interval. Palonosetron 0.075 mg was associated with less intense nausea (e.g., toward "mild" or "none") versus placebo during the 0-24 h (P < 0.001) time interval and significantly delayed median time to emesis (P = 0.002) and treatment failure (P = 0.004). Although CR rates for both the 0.025 mg and 0.050 mg palonosetron doses were not statistically superior to placebo for the 0-24 h or 24-72 h periods, both lower doses reduced nausea severity during the 0-24 h period (P = 0.040 and P = 0.004). CONCLUSION: A single 0.075-mg IV dose of palonosetron effectively reduced the severity of nausea and delayed the time to emesis and treatment failure in the inpatient surgical setting; lower doses were not as effective.


Asunto(s)
Antieméticos/administración & dosificación , Isoquinolinas/administración & dosificación , Náusea y Vómito Posoperatorios/prevención & control , Quinuclidinas/administración & dosificación , Antagonistas de la Serotonina/uso terapéutico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antieméticos/efectos adversos , Mama/cirugía , Método Doble Ciego , Femenino , Procedimientos Quirúrgicos Ginecológicos , Humanos , Inyecciones Intravenosas , Isoquinolinas/efectos adversos , Persona de Mediana Edad , Palonosetrón , Quinuclidinas/efectos adversos , Antagonistas de la Serotonina/efectos adversos , Insuficiencia del Tratamiento
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