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1.
Background: Many different doses and administration schemes have been proposed for the use of the antifibrinolytic drug tranexamic acid during cardiac surgery. This study evaluated the effects of the treatment using tranexamic acid during the intraoperative period only and compared the results with the effects of the treatment continued into the postoperative period.

Methods: Patients undergoing elective cardiac surgery with use of cardiopulmonary bypass (N = 510) were treated intraoperatively with tranexamic acid and then were randomized in a double-blind fashion to one of three postoperative treatment groups: group A: 169 patients, infusion of saline for 12 h; group B: 171 patients, infusion of tranexamic acid, 1 mg [middle dot] kg-1 [middle dot] h-1 for 12 h; group C: 170 patients, infusion of tranexamic acid, 2 mg [middle dot] kg-1 [middle dot] h-1 for 12 h. Bleeding was considered to be a primary outcome variable. Hematologic data, allogeneic transfusions, thrombotic complications, intubation time, and intensive care unit and hospital stay duration also were evaluated.

Results: No differences were found among groups regarding postoperative bleeding and outcomes; however, the group treated with 1 mg[middle dot]kg-1[middle dot]h-1 tranexamic acid required more units of packed red blood cells because of a significantly lower basal value of hematocrit, as shown by multivariate analysis.  相似文献   


2.
Background: Hip fracture surgery usually carries a high demand for rehabilitation and a significant risk of perioperative morbidity and mortality. Postoperative epidural analgesia may reduce morbidity and has been shown to facilitate rehabilitation in elective orthopedic procedures. No studies exist on the effect of postoperative epidural analgesia on pain and rehabilitation after hip fracture surgery.

Methods: Sixty elderly patients were included in a randomized, double-blind study comparing 4 days of continuous postoperative epidural infusion of 4 ml/h bupivacaine, 0.125%, and 50 [mu]g/ml morphine versus placebo. Both patient groups received balanced analgesia and intravenous nurse-controlled analgesia with morphine. All patients followed a well-defined multimodal rehabilitation program. Pain, ability to participate in four basic physical functions, and any factors restricting participation were assessed on the first 4 postoperative days during physiotherapy.

Results: Epidural analgesia provided superior dynamic analgesia during all basic physical functions, and patients were significantly less restricted by pain, which was the dominating restricting factor in the placebo group. Motor blockade was not a restricting factor during epidural analgesia. Despite improved pain relief, scores for recovery of physical independence were not different between groups.  相似文献   


3.
Background: A controversy exists over the effectiveness and clinical value of preemptive analgesia. Additional studies are needed to define the optimum intensity, duration, and timing of analgesia relative to incision and surgery.

Methods: One hundred twenty patients undergoing laparoscopic cholecystectomy under general anesthesia plus topical peritoneal local anesthetic or saline were studied. Local anesthetic (0.5% bupivacaine with epinephrine) or placebo solutions were given as follows: immediately after the creation of a pneumoperitoneum (blocking before surgery), and at the end of the operation (blocking after surgery). Patients were randomly assigned to one of four groups of 30 patients each. Group A (placebo) received 20 ml 0.9% saline both before and after surgery, group B received 20 ml 0.9% saline before surgery and 20 ml local anesthetic after surgery, group C received 20 ml local anesthetic both before and after surgery, group P received 20 ml local anesthetic before and 20 ml 0.9% saline after surgery. Pain was assessed using a visual analog scale and a verbal rating scale at 0, 4, 8, 12, and 24 h after surgery. Metabolic endocrine responses (blood glucose and cortisol concentrations) and analgesic requirements also were investigated.

Results: Pain intensity (visual analog and verbal rating scales) and analgesic requirements were significantly less in the group receiving bupivacaine after surgery compared to placebo. However, in the groups receiving bupivacaine before surgery, both pain intensity and analgesic consumption were less than in the group receiving bupivacaine only after surgery. Blood glucose and cortisol concentrations 3 h after surgery were significantly less in groups receiving bupivacaine before surgery.  相似文献   


4.
Background: Changing plasma protein concentrations may affect the protein binding and pharmacokinetics of drugs in the postoperative phase. Therefore, the authors evaluated the pharmacokinetics of ropivacaine, administered by 72-h epidural infusion to provide postoperative analgesia.

Methods: Twenty-eight patients, scheduled for major orthopedic surgery during combined epidural and general anesthesia received a bolus dose of ropivacaine (50 or 75 mg), followed by constant-rate (10 ml/h) epidural infusion of ropivacaine 2 mg/ml (group 1) or 3 mg/ml (group 2). Total and unbound plasma concentrations of ropivacaine and pipecoloxylidide and plasma concentrations of [alpha]1-acid glycoprotein were determined. In addition, the urinary excretion of ropivacaine and major metabolites was measured.

Results: Total plasma concentrations of ropivacaine increased steadily during the infusion, reaching 2.7 +/- 0.7 and 2.9 +/- 0.5 mg/l in groups 1 and 2 after 72 h constant-rate infusion. Unbound ropivacaine concentrations reached average steady state levels of approximately 0.06 and 0.07 mg/l. Total and unbound concentrations of pipecoloxylidide increased to 1.0 +/- 0.4 and 0.4 +/- 0.2 mg/l (group 1) and 1.2 +/- 0.4 and 0.5 +/- 0.1 mg/l (group 2) after 72 h infusion. [alpha]1-Acid glycoprotein concentrations initially decreased, but thereafter increased steadily to approximately twice the baseline values.  相似文献   


5.
目的:研究地佐辛对结肠癌根治术后罗哌卡持续切口镇痛作用的影响.方法:将40例择期行结肠癌根治术的患者随机分为地佐辛复合罗哌卡组(D组)和罗哌卡组(R组),手术结束后,进行切口局部浸润并放置渗透导管,D组经切口持续给予0.2%罗哌卡(内含地佐辛54μg/mL),R组给予0.2%罗哌卡.结果:D组术后12 h、24 h和48 h咳嗽和休息时VAS评分低R组(P<0.05),R组48 h内镇痛泵按压次数及舒芬太尼使用量明显高D组(P<0.05),恶心呕吐及嗜睡发生率R组高D组(P<0.05).肠蠕动恢复时间及术后离床时间,D组早R组(P<0.05).两组患者术后切口愈合良好,无1例发生切口感染.结论:地佐辛增强罗哌卡术后持续切口镇痛的效果,有利患者的术后早期恢复.  相似文献   

6.
Background  A standard approach for postoperative analgesia in laparoscopic surgery is to infiltrate the incisions with local anesthetic in combination with systemic opioids. The intraperitoneal introduction of local anesthetic in this setting has the potential to provide appropriate analgesia without the side effects of systemic opioids. We performed a randomized clinical trial of the On-Q pump delivery system to determine the safety and efficacy of this device for this novel purpose. Methods  Thirty patients undergoing laparoscopic adjustable gastric banding were randomly assigned to one of two groups. The treatment group received On-Q pump systems filled with 0.375% bupivacaine, while the control group received pumps filled with 0.9% normal saline. The pump’s catheter was introduced intraperitoneally, and bupivacaine or saline was then delivered for the first 48 h after surgery. Patient’s subjective pain scores were evaluated at preset intervals. In addition, shoulder pain, morphine requirements, and anti-emetic requirements were tabulated. Results  A statistically significant decrease in patient’s subjective reports of pain by visual analog score was noted in the On-Q group 1.8 ± 1.93 vs. control 3.5 ± 2.4, p < 0.046 and remained significant until the end of the study (48 h). No statistical difference was noted in shoulder pain, morphine requirements, or anti-emetic requirements at any time point. Conclusion  Our trial was able to provide evidence of significant reduction in postoperative pain as measured by subjective pain scores with the use of continuous intraperitoneal bupivacaine using the On-Q pain pump system. Further investigation is warranted to evaluate the cost effectiveness of this technique.  相似文献   

7.
Background: The aim of the study was to compare the efficacy of either ropivacaine or placebo through an iliac crest (IC) catheter after Bankart repair with IC bone grafting.

Methods: With approval of the local ethics committee and after written informed consent was obtained, 36 patients had an interscalene catheter placed preoperatively. Intraoperatively, the surgeon placed a catheter at the IC donor site. At the end of surgery, 30 ml ropivacaine, 0.5% (ropivacaine group), or 30 ml NaCl, 0.9% (placebo group), was administered. Ropivacaine, 0.2%, was started 6 h after the initial block through the interscalene catheter for 48 h (t48) in all patients. At t0, the patient received either 5 ml/h ropivacaine, 0.2% (ropivacaine group), or 5 ml/h NaCl, 0.9% (placebo group), for 48 h through the IC catheter. All patients received an intravenous morphine patient-controlled analgesia device. Pain scores at the shoulder and at the IC donor site were assessed at rest and during motion every 8 h for 48 h and after 3 months. Plasma concentrations of total and unbound ropivacaine, morphine consumption, and patient satisfaction were assessed.

Results: At the IC donor site, pain was significantly lower in the ropivacaine group compared with the placebo group at rest and during motion at any time. Total and unbound plasma concentrations of ropivacaine were below the toxic threshold in both groups. Morphine consumption was significantly lower in the ropivacaine group after 24 and 48 h. Patient satisfaction was significantly higher in the ropivacaine group. At 3 months, pain at the IC during motion was significantly lower in the ropivacaine group.  相似文献   


8.

Background  

Enhanced recovery after surgery programs have been introduced with aims of improving patient care, reducing complication rates, and shortening hospital stay following colorectal surgery. The aim of this meta-analysis was to determine whether enhanced recovery after surgery programs, when compared to traditional perioperative care, are associated with reduced primary hospital length of stay in adult patients undergoing elective colorectal surgery.  相似文献   

9.

Background

Meta-analyses in the literature show that enhanced recovery after surgery (ERAS) is associated with lower morbidity rate and shorter hospital stay after elective colorectal surgery. However, a recent Cochrane review did not indicate the ERAS pathway as being the new standard of care due to the limited number of published trials, together with their poor quality. We conducted a meta-analysis of randomized controlled trials (RCTs) to assess the impact of the ERAS pathway on overall morbidity, single postoperative complications, length of hospital stay, and readmission rate following colorectal surgery.

Methods

We searched BioMedCentral, PubMed, Scopus, and the Cochrane Central Register of Controlled Trials (CENTRAL) for RCTs comparing the ERAS pathway to conventional perioperative care. No language restrictions were considered. A quality score was calculated for each trial included.

Results

A total of 2,376 patients in 16 RCTs were included in the analysis. The ERAS pathway was associated with a reduction of overall morbidity [relative ratio (RR) = 0.60, (95 % CI 0.46–0.76)], particularly with respect to nonsurgical complications [RR = 0.40, (95 % CI 0.27–0.61)]. The reduction of surgical complications was not significant [RR = 0.76, (95 % CI 0.54–1.08)]. The ERAS pathway shortened hospital stay (WMD = ?2.28 days [95 % CI –3.09 to –1.47]), without increasing readmission rate.

Conclusions

The ERAS pathway reduced overall morbidity rates and shortened the length of hospital stay, without increasing readmission rates. A significant reduction in nonsurgical complications was evident, while no significant reduction was found for surgical complications.  相似文献   

10.
11.
Ren L  Zhu D  Wei Y  Pan X  Liang L  Xu J  Zhong Y  Xue Z  Jin L  Zhan S  Niu W  Qin X  Wu Z  Wu Z 《World journal of surgery》2012,36(2):407-414

Background

The aim of this trial was to compare the Enhanced Recovery After Surgery (ERAS) program with conventional perioperative management in patients who underwent radical resection for colorectal cancer.

Methods

A combination of evidence-based and consensus methodology was used to develop the ERAS protocol. Five hundred ninety-seven consecutive patients who underwent elective colorectal resection were randomized to either the ERAS (n?=?299) or the control group (n?=?298). Outcomes relating to nutrition and metabolism index, stress index, and recovery index were measured and recorded.

Results

Demographic and operative data were similar between the two groups. Patients in the ERAS group showed improved nutritional status when compared with those of the control group. On postoperative day (POD) 1, the HOMA-IR (insulin resistance index) of the ERAS group was lower than that of the control group (p?p?=?0.007) and POD 5 (p?=?0.002) compared to the preoperative level. However, the cortisol level of the ERAS group was not increased until POD 5 (p?=?0.001). Reduced levels of TNF-??, IL-1??, IL-6, and IFN-?? in the ERAS group indicated less postoperative stress responses. In addition, ERAS was associated with accelerated recovery of gastrointestinal function. The postoperative length of stay (p?p?Conclusion The ERAS protocol attenuates the surgical stress response and accelerates postoperative recovery without compromising patient safety.  相似文献   

12.
Background Colorectal cancer patients are often anemic before surgery, and this leads to an increased requirement for allogeneic blood transfusion. This may result in transfusion-induced immunosuppression, which in turn leads to increased morbidity and possibly an increased rate of tumor relapse. We investigated the possible benefits of perioperative epoetin alfa administration in anemic patients to correct hemoglobin levels and reduce transfusion needs.Methods A total of 223 colorectal cancer patients with anemia scheduled for surgery were randomized to a group that received epoetin alfa 150 or 300 IU/kg/day subcutaneously for 12 days (day -10 to +1) or to a control group. All received iron (200 mg/day by mouth) for 10 days before surgery. Hemoglobin levels, hematocrit, and the number of blood units transfused were recorded.Results A total of 204 patients were eligible for analysis. Mean hemoglobin levels and hematocrit were significantly higher in the 300 IU/kg group than in the control group, both 1 day before surgery (hemoglobin, P = .008; hematocrit, P = .0005) and 1 day after surgery (hemoglobin, P = .011; hematocrit, P = .0008). Blood loss during and after surgery was similar in all groups. Patients who received epoetin alfa 300 IU/kg required significantly fewer perioperative transfusion units than control patients (.81 vs. 1.32; P = .016) and significantly fewer postoperative units (.87 vs. 1.33; P = .023). There were no significant differences in the number of units in the 150 IU/kg group.Conclusions Preoperative epoetin alfa (300 IU/day) increases hemoglobin levels and hematocrit in colorectal surgery patients. These effects are associated with a reduced need for perioperative and postoperative transfusions.See Appendix 1 for a list of investigators in the Hellenic Surgical Oncology Perioperative EPO Study Group.  相似文献   

13.
Background: Prevention of bleeding episodes in noncirrhotic patients undergoing partial hepatectomy remains unsatisfactory in spite of improved surgical techniques. The authors conducted a randomized, placebo-controlled, double-blind trial to evaluate the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in major partial hepatectomy.

Methods: Two hundred four noncirrhotic patients were equally randomized to receive either 20 or 80 [mu]g/kg rFVIIa or placebo. Partial hepatectomy was performed according to local practice at the participating centers. Patients were monitored for 7 days after surgery. Key efficacy parameters were perioperative erythrocyte requirements (using hematocrit as the transfusion trigger) and blood loss. Safety assessments included monitoring of coagulation-related parameters and Doppler examination of hepatic vessels and lower extremities.

Results: The proportion of patients who required perioperative red blood cell transfusion (the primary endpoint) was 37% (23 of 63) in the placebo group, 41% (26of 63) in the 20-[mu]g/kg group, and 25% (15 of 59) in the 80-[mu]g/kg dose group (logistic regression model; P = 0.09). Mean erythrocyte requirements for patients receiving erythrocytes were 1,024 ml with placebo, 1,354 ml with 20 [mu]g/kg rFVIIa, and 1,036 ml with 80 [mu]g/kg rFVIIa (P = 0.78). Mean intraoperative blood loss was 1,422 ml with placebo, 1,372 ml with 20 [mu]g/kg rFVIIa, and 1,073 ml with 80 [mu]g/kg rFVIIa (P = 0.07). The reduction in hematocrit during surgery was smallest in the 80-[mu]g/kg group, with a significant overall effect of treatment (P = 0.04).  相似文献   


14.
15.
Clinical Trial ID: NCT0454597BACKGROUND: Mimetic wrinkles, commonly referred to as expression lines, form perpendicular to anatomical regions subjected to repeated facial muscle contraction. Neuromodulating peptides have biological activity and can offer a solution to those concerned with expression lines and facial aging. OBJECTIVE: The objective of this randomized, double-blind, placebo-controlled study was to assess the efficacy and tolerability of a line-targeting peptide serum (LTPS) as a stand-alone treatment in improving expression lines and skin health. METHODS: This was an institutional review board-approved study involving healthy subjects. Fifty-five female subjects, 35 to 60 years old, Fitzpatrick Skin Type I to VI, with mild to moderate global face fine lines and wrinkles were recruited. Subjects were randomized to apply LTPS or a placebo serum to their face twice daily for twelve weeks. Short-term efficacy was assessed after fifteen minutes of serum application at baseline. Long-term efficacy and tolerability, self-assessment questionnaire, and VISIA® clinical photography were performed at baseline, Weeks 4, 8, and 12. 3D PRIMOS CR imaging and wrinkle analysis were obtained at baseline and Weeks 8 and 12. RESULTS: The LTPS significantly improved expression lines at fifteen minutes (short term), Weeks 4, 8, and 12 (long term) when compared to the placebo serum as evaluated by a board-certified dermatologist. The LTPS significantly outperformed the placebo serum in improving skin parameters at all time points. VISIA and PRIMOS CR wrinkle analysis substantiated the LTPS’s efficacy. LTPS was well-perceived and well tolerated by the subjects. CONCLUSION: This IRB-approved clinical study demonstrated that LTPS was effective in improving expression lines, wrinkles, and skin health after twelve weeks of application.  相似文献   

16.
Background: Morphine and ketamine may prevent central sensitization during surgery and result in preemptive analgesia. The reliability of preemptive analgesia, however, is controversial.

Methods: Gastrectomy patients were given preemptive analgesia consisting of epidural morphine, intravenous low-dose ketamine, and combinations of these in a randomized, double-blind manner. Postsurgical pain intensity was rated by a visual analog scale, a categoric pain evaluation, and cumulative morphine consumption.

Results: Preemptive analgesia by epidural morphine and by intravenous low-dose ketamine were significantly effective but not definitive. With epidural morphine, a significant reduction in visual analog scale scores at rest was observed at 24 and 48 h, and morphine consumption was significantly lower at 6 and 12 h, compared with control values. With intravenous ketamine, visual analog scale scores at rest and morphine consumption were significantly lower at 6, 12, 24, and 48 h than those in control subjects. The combination of epidural morphine and intravenous ketamine provided definitive preemptive analgesia: Visual analog scale scores at rest and morphine consumption were significantly the lowest at 6, 12, 24, and 48 h, and the visual analog scale score during movement and the categoric pain score also were significantly the lowest among the groups.  相似文献   


17.
目的研究外科手术与急诊内镜手术治疗急性梗阻性化脓性胆管炎(AOSC)患者的效果比较。方法随机选取我院2013年6月至2016年6月88例AOSC住院患者,分为对照组和研究组(n=44),给予对照组患者外科手术治疗,给予研究组患者急诊内镜手术治疗,比较两组患者一般资料、黄疸减轻时间、胃肠功能恢复时间、腹痛缓解时间、引流管拔除时间、住院时间以及两组患者的治愈、死亡率、术后并发症发生情况。结果内镜手术的患者术后黄疸减轻时间、胃肠功能恢复时间、腹痛减轻时间、引流管拔除时间、住院时间明显低于外科手术治疗的患者(PO.05),内镜手术的治愈率是96%,明显高于外科手术的治愈率89%(P0.05)。表明内镜手术的并发症明显低于外科手术(P0.05)。结论急诊内镜手术治疗AOSC的效果要优于外科手术。  相似文献   

18.
Background: The influence of labor epidural fentanyl on the neonate is controversial. The purpose of this study was to determine whether epidural fentanyl has an impact on breast-feeding.

Methods: Women who previously breast-fed a child and who requested labor epidural analgesia were randomly assigned in a double-blinded manner to one of three groups: (1) no fentanyl group, (2) intermediate-dose fentanyl group (intent to administer between 1 and 150 [mu]g epidural fentanyl), or (3) high-dose epidural fentanyl group (intent to administer > 150 [mu]g epidural fentanyl). On postpartum day 1, the mother and a lactation consultant separately assessed whether the infant was experiencing difficulty breast-feeding, and a pediatrician assessed infant neurobehavior. All women were contacted 6 weeks postpartum to determine whether they were still breast-feeding.

Results: Sixty women were randomly assigned to receive no fentanyl, 59 were randomly assigned to receive an intermediate dose, and 58 were randomly assigned to receive high-dose fentanyl. On postpartum day 1, women who were randomly assigned to receive high-dose fentanyl reported difficulty breast-feeding (n = 12, 21%) more often than women who were randomly assigned to receive an intermediate fentanyl dose (n = 6, 10%), or no fentanyl (n = 6, 10%), although this did not reach statistical significance (P = 0.09). There was also no significant difference among groups in breast-feeding difficulty based on the lactation consultant's evaluation (40% difficulty in each group; P = 1.0). Neurobehavior scores were lowest in the infants of women who were randomly assigned to receive more than 150 [mu]g fentanyl (P = 0.03). At 6 weeks postpartum, more women who were randomly assigned to high-dose epidural fentanyl were not breast-feeding (n = 10, 17%) than women who were randomly assigned to receive either an intermediate fentanyl dose (n = 3, 5%) or no fentanyl (n = 1, 2%) (P = 0.005).  相似文献   


19.

Background

Botulinum toxin treatment has been investigated as a minimally invasive alternative to oral medications in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (LUTS/BPH).

Objective

To explore the efficacy of onabotulinumtoxinA 100 U, 200 U, and 300 U versus placebo in men with LUTS/BPH in a phase 2 dose-ranging study.

Design, setting, and participants

A multicenter double-blind randomized, placebo-controlled 72-wk study enrolled men ≥50 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥12, total prostate volume (TPV) 30–100 ml, and maximum flow rate (Qmax) 5–15 ml/s.

Intervention

Single transperineal (n = 63) or transrectal (n = 311) administration of placebo (n = 94) or onabotulinumtoxinA 100 U (n = 95), 200 U (n = 94), or 300 U (n = 97) into the prostate transition zone.

Outcome measurements and statistical analysis

The primary efficacy end point was a change from baseline in IPSS at week 12. Secondary end points were Qmax, TPV, and transition zone volume (TZV). Analysis of covariance and the Cochran-Mantel-Haenszel method assessed the efficacy and proportion of IPSS responders. Adverse events (AEs) were assessed.

Results and limitations

Significant improvements from baseline in IPSS, Qmax, TPV, and TZV were observed for all groups, including placebo, at week 12 (p < 0.001), with no significant differences between onabotulinumtoxinA and placebo. However, in an exploratory post hoc analysis, a significant reduction in IPSS versus placebo was observed with onabotulinumtoxinA 200 U in prior α-blocker users (n = 180) at week 12. AEs were comparable across all groups.

Conclusions

Reductions in LUTS/BPH symptoms were seen in all groups, including placebo, with no significant between-group differences owing to a large placebo effect from the injectable therapy. The findings from the post hoc analysis in men previously treated with α-blockers will be further explored in an appropriately designed study.

Trial registration

http://www.Clinical Trials.gov; NCT00284518.  相似文献   

20.
Background: Whether continuous thoracic epidural analgesia (TEA) and continuous paravertebral block (PVB) have similar analgesic effects in patients undergoing video- assisted thoracic surgery (VATS) lobectomy was compared in this study.Methods: In all, 86 patients undergoing VATS lobectomy were enrolled in the prospective, randomized clinical trial. Group E received TEA. Group P received PVB. The primary endpoint was postoperative 24-hour visual rating scale (VAS) on coughing. Side effects and postoperative complications were also analyzed.Results: Pain scores at rest or on coughing at 24 and 48 h postoperatively were significantly lower in group E than in group P (P <0.05). At 24 h postoperatively, more patients in group E suffered from vomiting (32.6% vs 11.6%, P = 0.019), dizziness (55.8% vs 12.9%, P = 0.009), pruritus (27.9% vs 2.3%, P = 0.002), and hypotension (32.6% vs 4.7%, P = 0.002) than those in group P. Patients in group E were more satisfied (P = 0.047). Four patients in group P and two patients in group E suffered from pulmonary complications (P >0.05). The length of hospital and intensive care unit (ICU) stays were not significantly different.Conclusions: Though TEA has more adverse events than PVB, it may be superior to PVB in patients undergoing VATS lobectomy.  相似文献   

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