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BACKGROUND@#Red-cell transfusion is critical for surgery during the peri-operative period; however, the transfusion threshold remains controversial mainly owing to the diversity among patients. The patient's medical status should be evaluated before making a transfusion decision. Herein, we developed an individualized transfusion strategy using the West-China-Liu's Score based on the physiology of oxygen delivery/consumption balance and designed an open-label, multicenter, randomized clinical trial to verify whether it reduced red cell requirement as compared with that associated with restrictive and liberal strategies safely and effectively, providing valid evidence for peri-operative transfusion.@*METHODS@#Patients aged >14 years undergoing elective non-cardiac surgery with estimated blood loss > 1000 mL or 20% blood volume and hemoglobin concentration <10 g/dL were randomly assigned to an individualized strategy, a restrictive strategy following China's guideline or a liberal strategy with a transfusion threshold of hemoglobin concentration <9.5 g/dL. We evaluated two primary outcomes: the proportion of patients who received red blood cells (superiority test) and a composite of in-hospital complications and all-cause mortality by day 30 (non-inferiority test).@*RESULTS@#We enrolled 1182 patients: 379, 419, and 384 received individualized, restrictive, and liberal strategies, respectively. Approximately 30.6% (116/379) of patients in the individualized strategy received a red-cell transfusion, less than 62.5% (262/419) in the restrictive strategy (absolute risk difference, 31.92%; 97.5% confidence interval [CI]: 24.42-39.42%; odds ratio, 3.78%; 97.5% CI: 2.70-5.30%; P <0.001), and 89.8% (345/384) in the liberal strategy (absolute risk difference, 59.24%; 97.5% CI: 52.91-65.57%; odds ratio, 20.06; 97.5% CI: 12.74-31.57; P <0.001). No statistically significant differences were found in the composite of in-hospital complications and mortality by day 30 among the three strategies.@*CONCLUSION@#The individualized red-cell transfusion strategy using the West-China-Liu's Score reduced red-cell transfusion without increasing in-hospital complications and mortality by day 30 when compared with restrictive and liberal strategies in elective non-cardiac surgeries.@*TRIAL REGISTRATION@#ClinicalTrials.gov, NCT01597232.
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Humanos , Adulto , Complicaciones Posoperatorias , Transfusión de Eritrocitos/efectos adversos , Transfusión Sanguínea , Hospitales , Hemoglobinas/análisisRESUMEN
Objective To investigate the effect of diabetes on clinical efficacy of transcatheter arterial chemoembolization (TACE) in the treatment of non-viral hepatitis hepatocellular carcinoma (HCC). Methods Retrospectively analyzed the clinical data of 367 non-hepatitis virus HCC patients treated by TACE, included 153 diabetes mellitus cases (test group) and blood glucose of 214 patients was normal (control group). To assess the treatment effect after 1 month of TACE based on response evaluation criteria in solid tumors, include complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), and calculate the disease control rate. Through 6 to 75 months follow-up to observed long-term efficacy, record the time to progression (TTP) and overall survival (OS) time. Survival rate were analyzed using Kaplan-Meier method and Log-rank analysis by SPSS 16.0. The single-factor analysis was used to analyze variables which variables that differed were analyzed by Cox regression. Results The disease control rate of test group was 69.9%(107/153) and control group was 74.3%(159/214), the difference was no statistically significant (P=0.125). The median time to progression (mTTP) and median overall survival (mOS) of test group were 10.0 and 15.0 months;and the mTTP and mOS of control group were 14.0 and 19.0 months, the difference were statistically significant (P=0.023 and P= 0.026). Tumor diameter ≥4.5 cm, numbers of tumor ≥3, invasion of blood vessels, α-fetoprotein≥200 μg/L, Eastern Cooperative Oncology Group score and diabetes were risk factors for OS of HCC patients. Conclusion Diabetes is unfavorable factors for overall survival of non-hepatitis HCC tread by TACE.
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Objective:To observe the dexmedetomidine by nasal drip on perioperative spinal surgery patients sedation and the effect of hemodynamic changes.Methods:90 ASA grade Ⅰ ～ Ⅲ,years 18 to 65,and in general anesthesia spinal surgery,and postoperative patients have to extube the endotracheal,were randomly divided into three groups:control group (group C),the dexmedetomidine 0.1 μg/kggroup (D1) and dexmedetomidine 1.5 μg/kggroup (D2),(n=30).Record into the OR (T0),before the induction (T1),1 min before intubation (T2),1 min after intubation (T3),start surgy (T4),began to stop general anesthetics (T5),1 min before extubation (T6),3 min after extubation (T7),and into the PACU (T8).The patient's heart rate (HR),mean arterial pressure (MAP),oxygen saturation (SPO2),finish operation from the general anesthetics toextube the endotracheal tube,stay time,patients in the postoperative recovery room Ramsay sedation scores.Results:Three groups of patients when T0 HR,MAP,SPO2,Ramsay sedation scores had no statistical difference (P≥ 0.05);Compared with group C,D1 and D2 group significantly lower each time point of HR,MAP,Ramsay sedation scores increase (P≤ 0.05),SPO2 no significant change (P≥ 0.05);Each time point compared with group D1,D2 group HR,MAP,significantly decreased,Ramsay sedation scores increase (P≤ 0.05),SPO2 no significant change (P≥ 0.05);D1 group HR,MAP,SPO2 at each time point,Ramsay sedation scores have no obvious difference (P≥ 0.05);D2 group HR,MAP,SPO2,Ramsay sedation scores significantly difference (P≥ 0.05).Group C T3,T4,T5,T6,T7 has each time point,T8 HR,MAP,up from T1,T2,Ramsay sedation scores were significantly improved (P≤ 0.05),SPO2 no significant change (P≥ 0.05).Conclusions:40 min before anesthesia induction dexmedetomidine by nasal drip can effectively inhibit intubation and extubation reaction,make the hemodynamic changes is more stable,and significantly reduce the incidence of patients with postoperative agitation.
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Objective To compare the efficacy of flurbiprofen axetil combined with fentanyl administered using different modes for postoperative analgesia.Methods This was a prospective,multicenter,randomized,double-blind,control,parallel-group study.ASA Ⅰ or Ⅱ patients,aged 14-91 yr,weighing 35-95 kg,scheduled for orthopedic,thoracic or hepatobiliary surgery under general anesthesia from January 2010 to October 2010,were randomly divided into A,B and C groups.The three groups received patient-controlled intravenous analgesia (PCIA) after surgery.In group A,flurbiprofen axetil 100 mg was injected immediately after the end of surgery and then PCIA was performed with fentanyl 1.0 mg in 100 ml of normal saline.In group B,PCIA was performed with flurbiprofen axetil 200 mg and fentanyl 0.6 mg in 100 ml of normal saline.In group C,flurbiprofen axetil 100 mg was injected immediately after the end of surgery and then PCIA was performed with flurbiprofen axetil 200 mg and fentanyl 0.6 mg in 100 ml of normal saline.The PCA pump was set up with a 2 ml bolus dose,a 10 min lockout interval and background infusion at a rate of 2 ml/h.VAS scores at rest and during activity and sedation score were recorded at the end of surgery and 4,8 and 24 h after surgery.The effective analgesia,excessive sedation,nausea and vomiting,dizziness,somnolence and respiratory depression were recorded within 24 h after surgery.Samples from the PCIA bump were taken to do microbe culture experiment at 24 and 48 h after surgery.Results Two thousand five hundred and ninety-six cases completed this trial (875 cases in group A,946 cases in group B and 775 cases in group C).Compared with group A,VAS scores at rest and during activity at the end of surgery and 4,8 and 24 h after surgery and sedation score were significantly decreased in group B,VAS scores at rest and during activity were significantly decreased at the end of surgery and 4 and 8 h after surgery and sedation scores were significantly increased at 4 and 8 h after surgery in group C,the rate of effective analgesia was increased in groups B and C,the incidence of excessive sedation was decreased in group B,while increased in group C,the incidence of postoperative nausea and vomiting was significantly decreased in groups B and C,and the incidence of postoperative dizziness was significantly decreased in group C (P ＜ 0.05).Compared with group B,no significant change was found in the VAS scores at rest and during activity,rate of effective analgesia,and incidences of nausea and vomiting,and somnolence (P ＞ 0.05),sedation scores were significantly increased at the end of operation and 4 and 8 h after surgery,the incidence of excessive sedation was increased,and the incidence of postoperative dizziness was decreased in group C (P ＜ 0.05).Neither bacterium nor fungus was found in the PCIA pump samples.Conclusion PCIA with flurbiprofen axetil 200 mg and fentanyl 0.6 mg (background infusion at a rate of 2 ml/h,2 ml bolus dose,10 min lockout interval) provides better efficacy and the occurrence of sides effects is low for the patients undergoing moderate or major operations.
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Objective To investigate the effects of different doses of dexmedetomidine on the anesthetic efficacy of propofol and remifentanil in patients undergoing plastic surgery.Methods Sixty ASA Ⅰ or Ⅱ patients of both sexes,aged 18-64 yr,weighing 45-75 kg,scheduled for elective plastic surgery,were randomly assigned into 3 groups (n =20 each):control group (C group),low loading dose dexmedetomidine group (D1 group) and high loading dose dexmedetomidine group (D2 group).Dexmedetomidine was infused at a rate of 0.4 μg· kg-1 · h-1 until 30 min before the end of surgery after a loading dose of dexmedetomidine 0.6 (group D1) or 1.0 μg/kg (group D2) was infused at 10 min before induction of anesthesia in groups D1 and D2.Anesthesia was induced with target-controlled infusion of propofol (target plasma concentraiton 4.0 μg/ml) and remifentanil (target effect-site concentraiton 2.0 ng/ml).After the patients lost consciousness,rocuronium 0.6 mg/kg was injected intravenously.The patients were mechanically ventilated after tracheal intubation.Anesthesia was maintained with target-controlled infusion of propofol (target plasma concentraiton 2.0-3.5 μg/ml) and remifentanil (target effectsite concentraiton 1.5-2.5 ng/ml).Narcotrend index was maintained at Class D.Narcotrend index,systolic pressure (SP),diastolic pressure (DP) and HR were recorded before anesthesia (baseline),at 10 min of dexmedetomidine infusion,at 0,1 and 5 min after tracheal intubation,at the end of dexmedetomidine infusion,and at 0,1and 5 min after removal of the endotracheal tube.The induction time,consumption of propofol and remifentanil,time for recovery of spontaneous breathing and orientation,extubation time,and Richmond Agitation Sedation Scale score at 10 min after removal of the endotracheal tube were recorded.The development of sinus bradycardia during operation and complications during recovery from anesthesia were also recorded.Results Compared with group C,the total consumption of propofol and remifentanil,Richmond Agitation Sedation Scale score at 10 min after removal of the endotracheal tube,and incidences of nausea,bucking and agitation during recovery from anesthesia,and Narcotrend index and HR at 10 min of dexmedetomidine infusion were significantly decreased in groups D1 and D2,and induction time was shortened in D2 group (P ＜ 0.05 or 0.01).The incidence of sinus bradycardia during operation was significantly higher in group D2 than in groups C and D1 (P ＜ 0.05).There was no significant difference in the time for recovery of spontaneous breathing and orientation,and extubation time between the three groups (P ＞ 0.05).There was no significant difference in SP,DP and HR before and after tracheal intubation and before and after removal of the endotracheal tube between groups D1 and D2 (P ＞ 0.05).Conclusion Infusion of dexmedetomidine at a rate of 0.4μg·kg-1 · h-1 after a loading dose of 0.6 μg/kg infused before induction of anesthesia can shorten the induction time,reduce the consumption of propofol and remifentanil,effectively inhibit the stress responses to tracheal intubation or removal of the endotracheal tube,and decrease the occurrence of side effects in patients undergoing plastic surgery.
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Objective To evaluate the efficacy of nalmefene antagonizing postoperative respiratory depression induced by opioids.Methods Two hundred and forty ASA Ⅰ orⅡpatients aged 18-64 yr with body weight fluctuating within 20% of the standard body weight were included in this multicenter,randomized,double-blind,positive drug-controlled study.Anesthesia was induced with etomidate 0.3 mg/kg and TCI of sufentanil(effect-site concentration 0.4.ng/ml).Tracheal intubation was facilitated with vecuronium 0.1 mg/kg or rocuronium 0.6mg/kg.The patients were mechanically ventilated.PETCO2 was maintained at 35-45 mm Hg.Anesthesia was maintained with sevoflurane+ sufentanil TCI(Ce=0.1-0.4 ng/ml).Patients undergoing neurosurgery and liver or kidney operation were excluded.The operation time was within 3 h.The residual effects of muscle relaxants were reversed after operation.The patients were randomly divided into 2 groups(n=120 each):group Ⅰneloxone andgroup Ⅱ nalmefene.Naloxone 0.1 mg or nalmefene 0.25 μg/kg was injected iv over 30 s and was repeated 5 min later if necessary until the respiratory rate＞10 bpm,PETCO2＜45 mm Hg and apnea time＜15 s.The total amount of naloxone was≤0.4 mg while that of nalmefene≤1 μg/kg.BP,HR,SpO2,PETCO2,respiratory rate and apnea time were recorded immediately before and at 2 and 5 min after haloxone/nalmefene administration and then every 5 min until 5 min after extubation.The recovery of spontaneous breathing within 30 min after naloxone/nalmefene administration,extubation time and Ramsay sedation score at 5 min after extubation were recorded.The patients were also observed for adverse reactions.Results Spontaneous breathing recovered within 30 min after naloxone/nalmefene administration in all patients in both groups.The extubation time was significantly shorter in nalmefene group than in naloxone group.There was no significant difference in Ramsay sedation score,BP,HR,SpO2 and incidence of adverse reactions between the 2 groups.Conclusion Nalmefene is better than naloxone in antagonizing opioid-induced postoperative respiratory depression.