RESUMEN
OBJECTIVE: To test whether patients require less volatile anesthetic after cardiopulmonary bypass (CPB). DESIGN: Prospective, observational clinical study. SETTING: Cardiovascular operating rooms of a large teaching hospital. PARTICIPANTS: Twenty adult patients undergoing surgery with CPB. INTERVENTIONS: Subjects received a computer-controlled fentanyl infusion designed to maintain effect site concentrations of 3 ng/mL, combined with a variable amount of isoflurane. MEASUREMENTS AND MAIN RESULTS: The end-tidal isoflurane concentration associated with a target bispectral index of 55 was recorded during skin preparation, after sternotomy, during rewarming, and after separation from CPB. Adjusted, geometric mean (95% confidence intervals), end-tidal isoflurane concentrations associated with a bispectral index of 55 were 0.46% (0.38% to 0.58%) during skin preparation, 0.47% (0.39% to 0.58%) after sternotomy, 0.35% (0.29% to 0.42%) during rewarming, and 0.36% (0.31% to 0.43%) after separation from CPB. The last 2 concentrations (recorded near the end and after CPB) were significantly (p < 0.05) less than the first 2 concentrations (recorded before CPB). CONCLUSION: Because the level of surgical stimulation was relatively constant and minimal at the times of the measurements, these results are consistent with a reduced need for isoflurane after compared with before CPB.
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Anestésicos por Inhalación/farmacología , Puente Cardiopulmonar , Electroencefalografía , Isoflurano/farmacología , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
Because no completely effective antiemetic exists for the prevention of postoperative nausea and vomiting (PONV), we hypothesize that a multimodal approach to management of PONV may reduce both vomiting and the need for rescue antiemetics in high-risk patients. After IRB approval, women undergoing outpatient laparoscopy were randomized to one of three groups. Group I (n = 60) was managed by using a predefined multimodal clinical care algorithm. Patients undergoing the same surgical procedure who received a standard balanced outpatient anesthetic with ondansetron 4 mg (Group II, n = 42) or placebo (Group III, n = 37) prophylaxis were chosen to establish baseline incidence of nausea and vomiting. None of the Group I patients vomited before discharge, compared with 7% in Group II (P = 0.07) and 22% in Group III (P = 0.0003). However, one patient (2%) in Group I required treatment for symptoms in the postanesthesia care unit, compared with 24% in Group II (P<0.0001) and 41% in Group III (P< 0.0001). Time to discharge-ready was significantly shorter in Group I (128, 118-139 min; mean, 95% confidence interval) versus Group II (162, 145-181 min; P = 0.0015) and Group III (192, 166-222 min; P = 0.0001). Patient satisfaction with control of PONV was not different between Group I and Group II. Return to normal daily activity and overall satisfaction were not different among groups. Multimodal management resulted in a 98% complete response rate and a 0% incidence of vomiting before discharge; however, this improvement did not result in an increased level of patient satisfaction when compared with routine monotherapy prophylaxis. We conclude that both multimodal management and routine monotherapy antiemetic prophylaxis resulted in an increased level of patient satisfaction than symptomatic treatment in this high-risk population.
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Procedimientos Quirúrgicos Ambulatorios , Antieméticos/uso terapéutico , Procedimientos Quirúrgicos Ginecológicos , Laparoscopía , Náusea y Vómito Posoperatorios/prevención & control , Adulto , Algoritmos , Antieméticos/administración & dosificación , Femenino , Humanos , Dolor Postoperatorio/tratamiento farmacológico , Método Simple Ciego , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: The safety and antiemetic efficacy of CP-122,721, a novel neurokinin-1 antagonist, was evaluated when administered alone or in combination with ondansetron. METHODS: Using a randomized, double-blind, placebo-controlled study design, CP-122,721 was initially compared with placebo and subsequently to ondansetron alone and in combination for prophylaxis against postoperative nausea and vomiting in 243 women undergoing abdominal hysterectomy. In the dose-ranging studies (n = 86), patients received either CP-122,721 100 mg (vs. placebo) or 200 mg (vs. placebo) orally 60-90 min before induction of anesthesia. In the interaction study (n = 157), patients received CP-122,721 200 mg or placebo 60-90 min before induction of anesthesia, and ondansetron 4 mg or saline 2 ml intravenously 15-30 min before the end of surgery. Patients assessed their level of nausea and pain on arrival in the postanesthesia care unit and at 0.5-, 1-, 1.5-, 2-, 4-, 8-, 12-, and 24-h intervals postoperatively. Emetic episodes, need for rescue antiemetic-antinausea medication, postoperative complications, and patient satisfaction were recorded. RESULTS: In the initial dose-ranging study, only 10% of the patients experienced emesis within the first 8 h after surgery with CP-122,721 200 mg compared with 50% in the placebo group. CP-122,721 200 mg also decreased the need for rescue medication (25% vs. 48%). CP-122,721 100 mg was less effective than 200 mg in decreasing the incidence of repeated episodes of emesis. In the interaction study, 6% of the patients receiving CP-122,721 200 mg orally experienced emesis less than 2 h after surgery compared with 17% with ondansetron alone. With combined therapy, only 2% experienced emesis. In addition, the median times for 75% of patients to remain free from postoperative nausea and vomiting were 82, 75, and 362 min in the ondansetron, CP-122,721, and combination groups, respectively. CONCLUSIONS: Oral CP-122,721 200 mg decreased emetic episodes compared with ondansetron (4 mg intravenously) during the first 24 h after gynecologic surgery; however, there was no difference in patient satisfaction.
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Antieméticos/uso terapéutico , Histerectomía/efectos adversos , Ondansetrón/uso terapéutico , Piperidinas/uso terapéutico , Náusea y Vómito Posoperatorios/prevención & control , Antagonistas de la Serotonina/uso terapéutico , Sustancia P/antagonistas & inhibidores , Administración Oral , Adulto , Antieméticos/efectos adversos , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Quimioterapia Combinada , Femenino , Humanos , Histerectomía/métodos , Inyecciones Intravenosas , Antagonistas del Receptor de Neuroquinina-1 , Piperidinas/efectos adversos , Placebos , Medicación Preanestésica , Factores de RiesgoRESUMEN
BACKGROUND: Dopamine is an agonist of alpha, beta, and dopaminergic receptors with varying hemodynamic effects depending on the dose of drug being administered. The purpose of this study was to measure plasma concentrations of dopamine in a homogeneous group of healthy male subjects to develop a pharmacokinetic model for the drug. Our hypothesis was that dopamine concentrations can be predicted from the infusion dose using a population-based pharmacokinetic model. METHODS: Nine healthy male volunteers aged 23 to 45 yr were studied in a clinical research facility within our academic medical center. After placement of venous and arterial catheters, dopamine was infused at 10 microg x kg(-1) x min(-1) for 10 min, followed by a 30-min washout period. Subsequently, dopamine was infused at 3 microg x kg(-1) x min(-1) for 90 min, followed by another 30-min washout period. Timed arterial blood samples were centrifuged, and the plasma was analyzed by high-performance liquid chromatography. Mixed-effects pharmacokinetic models using NONMEM software (NONMEM Project Group, University of California, San Francisco, CA) were used to determine the optimal compartmental pharmacokinetic model for dopamine. RESULTS: Plasma concentrations of dopamine varied from 12,300 to 201,500 ng/l after 10 min of dopamine infusion at 10 microg x kg(-1) x min(-1). Similarly, steady-state dopamine concentrations varied from 1,880 to 18,300 ng/l in these same subjects receiving 3-microg x kg(-1) x min(-1) infusions for 90 min. A two-compartment model adjusted for body weight was the best model based on the Schwartz-Bayesian criterion. CONCLUSIONS: Despite a homogeneous population of healthy male subjects and weight-based dosing, there was 10- to 75-fold intersubject variability in plasma dopamine concentrations, making standard pharmacokinetic modeling of less utility than for other drugs. The data suggest marked intraindividual and interindividual variability in dopamine distribution and/or metabolism. Thus, plasma dopamine concentrations in patients receiving dopamine infusion at identical rates may vary profoundly. Our data suggest that dosing dopamine based on body weight does not yield predictable blood concentrations.
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Dopamina/farmacocinética , Adulto , Dopamina/administración & dosificación , Dopamina/sangre , Semivida , Humanos , Infusiones Intravenosas , Masculino , Modelos BiológicosRESUMEN
OBJECTIVE: Pulse oximetry (SpO2) is the non-invasive standard for monitoring arterial oxygen saturation in patients undergoing anesthesia, but is subject to external interference by motion artifact, peripheral vasoconstriction, and low cardiac output. We hypothesized that oximetry signals could be acquired from the esophagus when peripheral pulse oximetry is unobtainable. Therefore, we tested an esophageal stethoscope which incorporates transverse oximetry photodetectors and emitters in patients undergoing coronary bypass surgery. METHODS: Immediately after induction of general anesthesia in 10 coronary artery bypass (CABG) patients, Criticare and Nellcor digital probes were positioned on the left hand, concurrent with placement of an esophageal SpO2 probe. A computer recorded 5,910 matched oximetry signals every 15 sec during an average of 2.5 hrs. All SpO2 measurements were before, and immediately after non-pulsatile, hypothermic cardiopulmonary bypass. Data represent the percentage (median value [range]) of the total monitored time that a SpO2 value was displayed. RESULTS: The Nellcor (99.8%, range 6.5-100%) and Criticare (99.7%, range 36.6-100%) acquired and displayed saturation signals more frequently (p = 0.003) than the esophageal monitor (75.3%, range 42.1-95.8%). The two standard digital oximeters had a mean difference of 0.9%, with a standard deviation of the differences of 0.9. The esophageal probe had a mean difference of -5.2% and -4.8%, with standard deviation of differences of 8.0 and 7.7 (compared to the Nellcor and Criticare monitors, respectively). A second-generation prototype shielded from electrocautery interference was tested in an additional 4 patients. The shielded prototype displayed signals more frequently (96.7%, range 68.4-100%) than the original esophageal prototype. CONCLUSIONS: Digital pulse oximetry failure is common in CABG patients, probably because of marginal cardiac output and peripheral vasoconstriction associated with hypothermia. Our study could not confirm that esophageal technology, which utilizes the esophagus as a site of transflectance oximetry, was superior to conventional digital pulse oximetry.
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Puente de Arteria Coronaria , Esófago , Monitoreo Fisiológico , Oximetría/instrumentación , Adulto , Anciano , Anestesia General , Femenino , Humanos , Masculino , Persona de Mediana Edad , Monitoreo Intraoperatorio , Monitoreo Fisiológico/instrumentación , Oximetría/métodos , Oxihemoglobinas/análisis , Procesamiento de Señales Asistido por ComputadorRESUMEN
BACKGROUND: Although prophylactic administration of antiemetics reduces the incidence of postoperative nausea, vomiting, or both (PONV), there is little evidence to suggest this improves patient outcomes. The authors hypothesized that early symptomatic treatment of PONV will result in outcomes, including time to discharge, unanticipated admission, patient satisfaction, and time to return to normal daily activities, that are similar to those achieved with routine prophylaxis. METHODS: Men and women (n = 575) scheduled for outpatient surgery during general anesthesia were randomized to receive either 4 mg intravenous ondansetron or placebo before operation and either 1 mg intravenous ondansetron or placebo if postoperative symptomatic treatment of PONV was necessary. Patients were stratified into subgroups by risk factors for PONV. RESULTS: No differences occurred in the time to discharge, rate of unanticipated admission, or time to return to normal activity between the prophylaxis and treatment groups. The reported level of satisfaction with control of PONV was 93% in the treatment arm and 97% in the prophylaxis arm, which fall within the limits defined a priori as clinically equivalent. Female patients with a history of motion sickness or PONV who were undergoing highly emetogenic procedures had a higher reported level of satisfaction with prophylaxis than with treatment (100% vs. 90%, P = 0.043); however, the level of satisfaction with the overall outpatient surgical experience was not different. CONCLUSION: Although PONV is unpleasant, the data indicate little difference in outcomes when routine prophylactic medications are administered versus simply treating PONV should symptoms occur.
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Anestesia General/efectos adversos , Antieméticos/administración & dosificación , Ondansetrón/administración & dosificación , Náusea y Vómito Posoperatorios/tratamiento farmacológico , Náusea y Vómito Posoperatorios/prevención & control , Adolescente , Adulto , Anciano , Femenino , Humanos , Inyecciones Intravenosas , Masculino , Persona de Mediana Edad , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: Hospital acquired renal dysfunction, most commonly caused by renal hypoperfusion, dramatically increases mortality in intensive care patients. Glomerular filtration rate (GFR) is rapidly altered during renal hypoperfusion, and a more rapid means of GFR measurement may prompt institution of renal-specific therapy. We hypothesized that a transcutaneous renal function monitor can rapidly and accurately assess acute changes in GFR within a time frame much shorter than the 2-4 hours currently available. METHODS: The study design was a prospective determination of the capability to measure GFR transcutaneously. In three different studies, concurrent transcutaneous measurement of GFR, using the rate of disappearance of 99mTc-diethylenetriaminepentaacetic acid (DTPA), was compared by correlation and standard deviation (SD) to reference standards of DTPA plasma clearance, serum inulin clearance, or serum creatinine. RESULTS: Continuous transcutaneous clearance (TC) measurement correlated with standard DTPA plasma clearance techniques (r = 0.93). Acute pharmacologically induced changes in GFR are detectable by TC measurement within 12-20 min, a time interval significantly affected by the data acquisition interval. Excess patient movement in the ICU patients created clearance artifacts in 50% of clearance traces. Retrospective analysis of ICU patient data reveal TC measurements are 93% specific and 92% sensitive for serum creatinine levels in critically ill patients. CONCLUSIONS: TC monitoring provides prompt indication of directional changes in GFR and may provide the clinician warning of inadequate resuscitation. Prospective analysis of the specificity, sensitivity, and TC guided renal-specific resuscitation is needed.
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Tasa de Filtración Glomerular , Hemodinámica , Fallo Renal Crónico/diagnóstico , Monitoreo Fisiológico/métodos , Enfermedad Crítica , Humanos , Riñón/irrigación sanguínea , Riñón/fisiopatología , Ácido Pentético/metabolismo , Ácido Pentético/uso terapéutico , Complicaciones Posoperatorias/diagnóstico , Valores de ReferenciaRESUMEN
UNLABELLED: We evaluated the safety and efficacy of RS-25259, a potent and long-acting selective 5-HT3 receptor antagonist, for the prevention of postoperative nausea and vomiting (PONV) in women undergoing hysterectomy procedures. In this randomized, double-blind, placebo controlled, dose-ranging study, 218 healthy, consenting women were assigned to one of the six treatment groups: placebo or RS-25259 0.1, 0.3, 1.0, 3.0, or 30 microg/kg. All patients underwent a standardized general anesthetic technique. The study medication was administered i.v. 20-30 min before the end of surgery. During the initial 24-h period after surgery, the incidence of vomiting, the need for rescue antiemetics, the time to the first episode of emesis, and administration of rescue antiemetic medication, as well as a nausea visual analog scale and verbal categorical scale scores were recorded. In addition, recovery times from the end of anesthesia and the incidences of perioperative side effects were noted. Only 30 microg/kg RS-25259 significantly decreased the incidence of vomiting and the requirement for rescue antiemetics. The largest dose of RS-25259 also delayed the time to the first emetic episode and reduced the number of treatment failures. However, no differences were found in the severity of postoperative nausea (versus saline), and postoperative headaches were more common after the administration of RS-25259 0.3-30 microg/kg i.v. In conclusion, RS-25259 30 microg/kg i.v. was effective in reducing the incidence of PONV after major gynecologic surgery, but the occurrence of headaches with the larger doses of RS-25259 is a concern. IMPLICATIONS: RS-25259, a long-acting 5-HT3 antagonist, was effective in reducing postoperative vomiting only at the largest dose studied (30 microg/kg). However, RS-25259 had no antinausea activity, and the larger doses were associated with an increased incidence of headaches in the postoperative period.
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Antieméticos/uso terapéutico , Histerectomía , Isoquinolinas/uso terapéutico , Náusea/prevención & control , Complicaciones Posoperatorias/prevención & control , Antagonistas de la Serotonina/farmacología , Vómitos/prevención & control , Adulto , Método Doble Ciego , Femenino , Humanos , Infusiones Intravenosas , Isoquinolinas/administración & dosificación , Isoquinolinas/efectos adversosRESUMEN
STUDY OBJECTIVE: To compare the efficacy of ondansetron, droperidol, or metoclopramide with placebo in preventing postoperative vomiting following strabismus surgery. STUDY DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: University outpatient surgery center. PATIENTS: 160 ASA physical status I and II children ages 1 to 12 years who were scheduled for strabismus surgery. INTERVENTIONS: Administration of either ondansetron 100 mcg/kg, metoclopramide 250 mcg/kg, droperidol 75 mcg/kg, or placebo intravenously after induction of anesthesia. MEASUREMENTS AND MAIN RESULTS: Both ondansetron and droperidol were superior to metoclopramide and placebo in preventing predischarge vomiting, with incidences of 5%, 5%, 32%, and 25%, respectively. However, there was no difference in the incidence of postdischarge vomiting among the groups (ondansetron 25%, droperidol 25%, metoclopramide 20%, and placebo 25%). CONCLUSIONS: While both ondansetron and droperidol are more effective than metoclopramide when compared with placebo in decreasing the incidence of predischarge vomiting, none of these drugs was more effective than placebo in decreasing the incidence of postdischarge vomiting. Recovery from anesthesia was not significantly different among the groups as assessed by time to awakening, initial Steward score, and time to discharge.
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Antieméticos/uso terapéutico , Droperidol/uso terapéutico , Metoclopramida/uso terapéutico , Ondansetrón/uso terapéutico , Estrabismo/cirugía , Vómitos/prevención & control , Procedimientos Quirúrgicos Ambulatorios , Niño , Preescolar , Método Doble Ciego , Femenino , Humanos , Lactante , Masculino , Complicaciones Posoperatorias/prevención & control , Estudios ProspectivosRESUMEN
UNLABELLED: This study was conducted to determine the efficacy and safety of four intravenous (I.V.) doses of dolasetron, an investigational 5-HT3 receptor antagonist, for the treatment of postoperative nausea and/or vomiting (PONV) after outpatient surgery under general anesthesia. This multicenter, randomized, double-blind trial compared the antiemetic efficacy of 12.5, 25, 50, or 100 mg I.V. dolasetron with placebo over 24 h using complete response (no emetic episodes and no rescue medication), time to first emetic episode or rescue medication, and patient nausea and satisfaction with antiemetic therapy as rated by visual analog scale (VAS). Of 1557 patients enrolled, 620 patients were eligible for treatment. Complete response rates for all dolasetron doses--12.5 mg (35%), 25 mg (28%), 50 mg (29%), and 100 mg (29%)--were significantly more effective than placebo (11%, P < 0.05). There was a significant gender interaction for complete response (P < 0.01). Of the patients in the 25-mg and 100-mg dose groups, 12% and 13%, respectively, experienced no nausea (VAS score < 5 mm) versus 5% in the placebo group (P < 0.05). There were no clinically relevant changes in vital signs or laboratory values and no trends with dose for adverse events. Dolasetron is effective for treating PONV and has an adverse event profile similar to that of placebo. The 12.5-mg dose was as effective as larger doses for complete response. IMPLICATIONS: Nausea and vomiting are common problems for postsurgical patients. In this study of 620 patients undergoing surgery, a 12.5-mg dose of intravenous dolasetron, a new serotonin-receptor blocker, was significantly more effective than placebo in treating established postoperative nausea and vomiting. Dolasetron 12.5 mg was as safe as placebo.
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Antieméticos/administración & dosificación , Indoles/administración & dosificación , Náusea/tratamiento farmacológico , Complicaciones Posoperatorias/tratamiento farmacológico , Quinolizinas/administración & dosificación , Vómitos/tratamiento farmacológico , Adulto , Procedimientos Quirúrgicos Ambulatorios , Anestesia General , Antieméticos/efectos adversos , Método Doble Ciego , Femenino , Humanos , Indoles/efectos adversos , Inyecciones Intravenosas , Modelos Logísticos , Masculino , Satisfacción del Paciente , Quinolizinas/efectos adversosRESUMEN
OBJECTIVES: To determine the optimal dosing of doxacurium as a continuous infusion in neurosurgical patients with traumatic brain injury; to determine the effects of bolus administration of doxacurium on heart rate (HR), blood pressure (BP), and intracranial pressure (ICP); to monitor neuromuscular recovery after discontinuation of prolonged doxacurium infusion; and to compare the cost of doxacurium with other current neuromuscular blocking drugs. DESIGN: Prospective, open-label study. SETTING: Neurosurgical intensive care unit (ICU) of a university-affiliated teaching hospital. PATIENTS: Eight critically ill, mechanically ventilated patients with traumatic head injury and normal renal and hepatic function. Patients had ICP monitoring. INTERVENTIONS: A bolus injection of doxacurium (0.05 mg/kg) followed by a continuous infusion (0.015 mg/kg/hr), adjusted to maintain one twitch during Train-of-Four nerve stimulation of the adductor pollicis muscle. MEASUREMENTS AND MAIN RESULTS: Bolus injections of doxacurium did not alter the HR, BP, or ICP. Patients were paralyzed 66 +/- 12 (SEM) hrs, with recovery of the fourth twitch occurring 118 +/- 19 mins after infusion of the doxacurium was discontined. There were no incidences of prolonged weakness, myopathy, or other adverse events. CONCLUSIONS: Continuous infusion of doxacurium provides stable neuromuscular blockade for neurosurgical patients with traumatic brain injury. Doxacurium is devoid of clinically important interactions with HR, BP, or ICP and is less costly than other neuromuscular blockers used in the ICU.
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Lesiones Encefálicas/cirugía , Cuidados Críticos , Isoquinolinas/administración & dosificación , Fármacos Neuromusculares no Despolarizantes/administración & dosificación , Adulto , Presión Sanguínea/efectos de los fármacos , Lesiones Encefálicas/fisiopatología , Cuidados Críticos/economía , Cuidados Críticos/métodos , Relación Dosis-Respuesta a Droga , Femenino , Frecuencia Cardíaca/efectos de los fármacos , Humanos , Infusiones Intravenosas , Presión Intracraneal/efectos de los fármacos , Isoquinolinas/economía , Isoquinolinas/uso terapéutico , Masculino , Persona de Mediana Edad , Fármacos Neuromusculares no Despolarizantes/economía , Fármacos Neuromusculares no Despolarizantes/uso terapéutico , Neurocirugia , Estudios Prospectivos , Respiración ArtificialRESUMEN
OBJECTIVE: To evaluate the risk of phlebitis associated with chlorhexidine-coated polyurethane catheters in peripheral veins. DESIGN: A randomized, double-blinded trial comparing chlorhexidine-coated polyurethane catheters with uncoated polyurethane catheters. SETTING: A university hospital. PATIENTS: Adult medicine and surgery patients. INTERVENTIONS: Certified registered nurse anesthetists or an infusion team consisting of nurses and physicians inserted the catheters. Catheter insertion sites were scored twice daily for evidence of phlebitis. At the time catheters were removed, a quantitative blood culture was performed, and catheters were sonicated for quantitative culture. RESULTS: Of 221 evaluable catheters, phlebitis developed in 18 (17%) of 105 coated catheters, compared to 27 (23%) of 116 uncoated catheters (relative risk [RR], 0.74; 95% confidence interval [CI95], 0.43-1.26; P = .32). By survival analysis, chlorhexidine-coated catheters had a lower risk of phlebitis during the first 3 days (P = .06), but not when all catheters were considered in both patient groups (P = .31). In the absence of catheter colonization, the incidence of phlebitis was 21% (16/76) and 24% (20/86) for coated and uncoated catheters, respectively (P = .85), whereas in the presence of catheter colonization, the incidence of phlebitis was 14% (1/7) and 80% (4/5) for coated and uncoated catheters, respectively (RR, 0.18; CI95, 0.03-1.15; P = .07). CONCLUSION: The risk of phlebitis in the presence of catheter colonization was 82% lower for chlorhexidine-coated polyurethane catheters compared to otherwise identical uncoated catheters.
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Antiinfecciosos Locales/administración & dosificación , Cateterismo Periférico/efectos adversos , Catéteres de Permanencia/microbiología , Clorhexidina/administración & dosificación , Infección Hospitalaria/prevención & control , Contaminación de Equipos/prevención & control , Flebitis/prevención & control , Adulto , Cateterismo Periférico/métodos , Catéteres de Permanencia/efectos adversos , Intervalos de Confianza , Método Doble Ciego , Femenino , Humanos , Control de Infecciones/métodos , Control de Infecciones/normas , Masculino , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Riesgo , Tamaño de la Muestra , Staphylococcus/aislamiento & purificación , Análisis de SupervivenciaRESUMEN
The purpose of this study was to test the hypothesis that using a 1:4 ratio of remifentanil to alfentanil, a remifentanil infusion would provide better suppression of intraoperative responses and comparable recovery profiles after ambulatory laparoscopic surgery than an alfentanil infusion, as part of total intravenous anesthesia. Two hundred ASA physical status I, II, or III adult patients participated in this multicenter, double-blind, parallel group study. Patients were randomly assigned 2:1 to either the remifentanil-propofol or alfentanil-propofol regimens. The anesthesia sequence was propofol (2 mg/kg intravenously [IV] followed by 150 micrograms.kg-1.min-1), and either remifentanil (1 microgram/kg IV followed by 0.5 microgram.kg-1.min-1)of alfentanil (20 micrograms/kg IV followed by 2 micrograms.kg-1.min-1), and vecuronium. After trocar insertion, infusion rates were decreased (propofol to 75 micrograms.kg-1.min-1; remifentanil to 0.25 microgram.kg-1.min-1; alfentanil to 1 microgram.kg-1.min-1). Alfentanil and propofol were discontinued at 10 and 5 min, respectively, before the anticipated end of surgery (last surgical suture); remifentanil was discontinued at the end of surgery. Recovery times were calculated from the end of surgery. The median duration of surgery was similar between groups (39 min for remifentanil versus 34 min for alfentanil). A smaller proportion of remifentanil patients than alfentanil patients had any intraoperative responses (53% vs 71%, P = 0.029), had responses to trocar insertion (11% vs 32%, P < 0.001), or required dosage adjustments during maintenance (24% vs 41%, P < 0.05). Early awakening times were similar. Remifentanil patients qualified for Phase 1 discharge later and were given postoperative analgesics sooner than alfentanil patients (P < 0.05). Actual discharge times from the ambulatory center were similar between groups (174 min for remifentanil versus 204 min for alfentanil) (P = 0.06). In conclusion, remifentanil can be used for maintenance of anesthesia in a 1:4 ratio compared with alfentanil, for total IV anesthesia in ambulatory surgery. This dose of remifentanil provides more effective suppression of intraoperative responses and does not result in prolonged awakening.
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Alfentanilo/uso terapéutico , Atención Ambulatoria/métodos , Laparoscopía/métodos , Piperidinas/uso terapéutico , Adulto , Anestesia Intravenosa , Femenino , Humanos , Masculino , Persona de Mediana Edad , Remifentanilo , Factores de TiempoRESUMEN
This study was designed to test the hypothesis that there is a direct prophylactic antiemetic effect of small-dose propofol given by continuous infusion. Sixty female patients undergoing outpatient laparoscopy under general anesthesia were randomized to receive, in a double-blind fashion, either a bolus of 0.1 mg/kg followed by a constant infusion of 1 mg.kg-1.h-1 of propofol or an equivalent volume of 10% Intralipid (placebo) beginning 30 min before induction of anesthesia and continuing until discharge from Stage I postanesthesia care unit (PACU). Anesthesia was induced and maintained in a standard fashion in all patients. The number of emetic episodes before and after discharge from PACU, nausea scores (11-point numerical scale), and time to discharge were evaluated. No significant differences between Intralipid and propofol were found for any of the outcome variables tested. While small-dose propofol is an effective adjuvant in reducing chemotherapy-induced emesis, we were unable to demonstrate any beneficial effect of propofol in reducing postoperative nausea and vomiting when used as the sole prophylactic medication in this patient population. Propofol may have a synergistic effect when administered with other antiemetics, or the specific antiemetic effect of propofol, if it exists, may be dose-dependent and the dose used in this study was below the efficacy threshold.
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Procedimientos Quirúrgicos Ambulatorios , Anestesia General/efectos adversos , Antieméticos/administración & dosificación , Laparoscopía , Complicaciones Posoperatorias/prevención & control , Propofol/administración & dosificación , Vómitos/prevención & control , Adolescente , Adulto , Anciano , Método Doble Ciego , Femenino , Humanos , Bombas de Infusión , Persona de Mediana Edad , Vómitos/inducido químicamenteRESUMEN
STUDY OBJECTIVES: To determine (1) the efficacy and safety of ondansetron in the prevention of postoperative nausea and vomiting (PONV) in male outpatients; (2) prognostic factors for PONV in male outpatients; and (3) patients' perceptions of the debilitating effects of PONV in the ambulatory surgery setting. DESIGN: Prospective, randomized, stratified, double-blind study. SETTING: Multicenter-24 medical centers. PATIENTS: 468 ASA physical status I and II males at least 12 years of age scheduled for general anesthesia. INTERVENTIONS: All patients received intravenous ondansetron 4 mg or placebo prior to undergoing general balanced (opioid) anesthesia. MEASUREMENTS AND MAIN RESULTS: In the postanesthesia care unit (PACU), the number of emetic episodes, vital signs, adverse events, and nausea assessments were recorded by a blinded observer. After discharge, and until the end of the 24-hour study period, patients completed a diary that collected emetic episodes, adverse events, nausea, and pharmacoeconomic data. There were no differences in patient demographics or safety profiles between groups. The number of patients with no emesis and no nausea during the 24-hour study period was significantly greater (p < 0.05) with ondansetron 4 mg compared with placebo. Prognostic factors for an increased likelihood of developing PONV in males included a history of motion sickness or previous PONV, patients undergoing nonorthopedic procedures, and surgeries lasting longer than one hour. Finally, 38% of patients experiencing PONV perceived PONV to be as, or more debilitating than, the aftereffects of surgery itself. CONCLUSIONS: Ondansetron 4 mg was more effective than placebo in preventing PONV in male outpatients. Males at potential risk for developing PONV include: (1) those with a history of motion sickness and/or PONV; (2) patients undergoing nonorthopedic procedures; and (3) procedures lasting longer than one hour. Such patients may benefit from receipt of a prophylactic antiemetic. Postoperative nausea and vomiting has a debilitating effect that can be differentiated by patients from the effects of surgery itself.
Asunto(s)
Procedimientos Quirúrgicos Ambulatorios , Antieméticos/uso terapéutico , Ondansetrón/uso terapéutico , Complicaciones Posoperatorias/prevención & control , Vómitos/prevención & control , Adulto , Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Procedimientos Quirúrgicos Ambulatorios/clasificación , Periodo de Recuperación de la Anestesia , Anestesia General , Antieméticos/administración & dosificación , Actitud Frente a la Salud , Niño , Método Doble Ciego , Estudios de Seguimiento , Humanos , Inyecciones Intravenosas , Masculino , Registros Médicos , Mareo por Movimiento/complicaciones , Náusea/prevención & control , Ondansetrón/administración & dosificación , Alta del Paciente , Placebos , Premedicación , Pronóstico , Estudios Prospectivos , Factores de Riesgo , Factores de TiempoRESUMEN
STUDY OBJECTIVE: To compare the efficacy of two different oxygen (O2) delivery systems in preventing episodic arterial desaturation in the immediate postoperative period. STUDY DESIGN: Randomized, prospective, nonblinded comparison in patients. SETTING: Operating room and postanesthesia care unit (PACU) of a university outpatient surgery center. PATIENTS: 100 ASA status I and II adults, male and female, age greater than 18 years, undergoing outpatient surgical procedures not involving the upper airway. INTERVENTIONS: Group I received supplemental O2 administered by bag-valve-mask during transport, followed by 40% face shield in the PACU. Group 2 received supplemental O2 by nasal cannula at 4 L/min both during transport and during PACU stay. MEASUREMENTS AND MAIN RESULTS: Arterial O2 saturation (SpO2) was collected by computer from a recording pulse oximeter at 15-second intervals beginning before extubation and continuing until O2 administration was discontinued in PACU. Neither mode of therapy was successful in completely eliminating arterial desaturation defined as SpO2 less than 90%, nor was there any difference in efficacy between the two treatment groups. Group 1 had 8 patients desaturate on 9 different occasions (5 times during transport, 4 times in PACU). Group 2 had 5 patients desaturate on 9 different occasions (4 times during transport, 5 times in PACU). CONCLUSION: Routine O2 administration during transport and PACU stay did not abolish episodic desaturation, even in healthy patients undergoing minor surgical procedures. Given the marked difference in acquisition cost, it would appear that O2 administration by nasal cannula is a more cost-effective alternative for routine postoperative O2 administration in certain groups of patients undergoing general anesthesia for outpatient surgery.
Asunto(s)
Procedimientos Quirúrgicos Ambulatorios , Terapia por Inhalación de Oxígeno , Oxígeno/sangre , Adulto , Monitoreo de Gas Sanguíneo Transcutáneo , Femenino , Frecuencia Cardíaca , Humanos , Masculino , Persona de Mediana Edad , Terapia por Inhalación de Oxígeno/instrumentación , Terapia por Inhalación de Oxígeno/métodos , Enfermería Posanestésica , Periodo Posoperatorio , Sala de Recuperación , Análisis de Regresión , Transporte de PacientesRESUMEN
The selection and administration of neuromuscular blocking (NMB) drugs in intensive care unit (ICU) patients remain controversial. We compared the dose-response and recovery pharmacodynamics of a new intermediate-acting NMB drug, cisatracurium besylate, to the intermediate-acting NMB drug, vecuronium (VEC), in a prospective, randomized, double-blind, multicenter study in critically ill adults. After informed consent, 58 mechanically ventilated ICU patients from five medical centers were randomized to receive either cisatracurium or VEC. Fifty-four of the 58 patients received NMB drugs before entering this study but demonstrated at least partial recovery (> or = one twitch) in the train-of-four (TOF) response before initiation of the NMB study drug. NMB drug infusion was titrated by peripheral nerve stimulation to maintain at least one twitch in the TOF response. NMB drugs were infused for 1-5 days. After discontinuation of NMB drug infusion, recovery of neuromuscular transmission was monitored with an accelerometer. NMB drug infusion for 28 cisatracurium patients averaged 2.6 +/- 0.2 (mean +/- SEM) micrograms.kg-1.min-1 with a mean duration of 80 +/- 7 h. After discontinuing cisatracurium administration, recovery to 70% TOF ratio averaged 68 +/- 13 min. The mean infusion rate for 30 VEC patients was 0.9 +/- 0.1 micrograms.kg-1.min-1 with a mean duration of 66 +/- 12 h. Neuromuscular recovery after VEC averaged 387 +/- 163 min, which was significantly longer (P = 0.02) than that after cisatracurium. Prolonged recovery of neuromuscular function after discontinuation of NMB drug infusion (identified by the primary investigator at each medical center) was reported in two cisatracurium patients and 13 VEC patients (P = 0.002), and occurred despite the routine use of neuromuscular twitch monitoring. Seven VEC and one cisatracurium patients died during the infusion of study drug or within 48 h after discontinuation of the NMB drug infusion. In summary, we found recovery of neuromuscular function after discontinuation of NMB drug infusion in ICU patients is significantly faster with cisatracurium than with VEC. In addition, routine neuromuscular monitoring was not sufficient to eliminate prolonged recovery and myopathy in ICU patients.
Asunto(s)
Atracurio/administración & dosificación , Cuidados Críticos , Bromuro de Vecuronio/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Atracurio/farmacología , Enfermedad Crítica , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Estimulación Eléctrica , Femenino , Humanos , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico , Unión Neuromuscular/efectos de los fármacos , Estudios Prospectivos , Respiración Artificial , Estereoisomerismo , Transmisión Sináptica/efectos de los fármacos , Nervio Cubital/efectos de los fármacos , Bromuro de Vecuronio/farmacologíaRESUMEN
OBJECTIVE: To compare the neuromuscular-blocking and hemodynamic effects of doxacurium vs. pancuronium administered by intermittent bolus to intensive care unit (ICU) patients who required neuromuscular block to facilitate mechanical ventilation for > or = 24 hrs. DESIGN: A multicenter, prospective, double-blind, randomized study comparing doxacurium, a new benzylisoquinolone neuromuscular-blocking agent, with pancuronium. SETTING: ICUs of three tertiary care hospitals. PATIENTS: Forty critically ill patients (29 male, 11 female) with an average age of 52.5 yrs (range 19 to 80). INTERVENTIONS: With approval of our Institutional Review Boards and after obtaining informed consent, 40 critically ill patients were entered into the study. Histories and the results of physical examinations were recorded, laboratory data were collected, and Acute Physiology and Chronic Health Evaluation (APACHE) II scores were calculated during the 8 hrs before the start of the study medication. Patients received either doxacurium (initial dose of 0.04 mg/kg) or pancuronium (initial dose of 0.07 mg/kg) by bolus injection with continuous measurement of vital signs every minute for 15 mins. We measured the degree of neuromuscular blockade using a peripheral-nerve stimulator to measure the Train-of-Four count. Patients were rebolused (doxacurium dose of 0.025 mg/kg, pancuronium dose of 0.05 mg/kg) based on clinical criteria, which were substantiated by measurement of the Train-of-Four count. The neuromuscular-blocking drugs were stopped when the patient no longer required paralysis or after 5 days of therapy, whichever came first. Group comparisons were made using repeated measures analysis of variance, Fisher's exact test, and two sample t-tests, when appropriate. Spearman's rank-correction coefficients were calculated to assess the relationship of onset time and recovery time with all baseline laboratory values and the APACHE II scores. A p < .05 was used to establish statistical significance. MEASUREMENTS AND MAIN RESULTS: There were no differences between the two groups with respect to age, gender, or APACHE II scores. There were no differences between groups in terms of adverse experiences, nor with respect to time of onset of block, number of doses, or the duration of neuromuscular blockade (2.6 vs. 2.2 days for doxacurium vs. pancuronium, respectively). There was a statistically significant increase in heart rate after the initial dose of pancuronium (120 +/- 23 vs. 109 +/- 22 beats/min postinjection vs. preinjection, respectively; p < .05) without any differences noted after doxacurium (107 +/- 21 vs. 109 +/- 21 beats/min, respectively). Furthermore, once neuromuscular block was discontinued, the pancuronium group had a more prolonged and variable recovery time (279 +/- 229 mins) compared with the doxacurium group (138 +/- 46 mins, p < .05). CONCLUSIONS: In critically ill patients requiring neuromuscular block for > 24 hrs, doxacurium was well tolerated without evidence of tachycardia and with a relatively prompt recovery profile.