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临床试验/NCT02327910
NCT02327910Unknown不适用

The Clinical Value of Applying Qualitative TOF Monitoring and Transcutaneous Partial Pressure of Carbon Dioxide to Guide Elderly Patients Extubation

Beijing Municipal Science & Technology Commission0 个研究点目标入组 300 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
The comparison between groups of postoperative respiratory adverse events

研究概览

简要总结

Three hundred aged(age>65y) patients were randomized to Commom group(C group). Qualitative TOF monitoring (TOF group). Qualitative TOF and transcutaneous partial pressure of carbon dioxide monitoring(Unite group). Anesthetic management was standardized in all subjects .The patients of C group were extubated when standard criteria were met; T group patients had a TOF ratio of greater than 0.90 as an additional extubation criterion;and U group patiens were extubated when TOF ratio is greater than 0.90 and meanwhile transcutaneous partial pressure of carbon dioxide recovered to preoperative ±5mmHg .All the patients were transport to the PACU after extubation.Compare the adverse respiratory events at the moment of extubation, on the arrival of PACU, at 30min and 60min moment in the PACU respectively.

详细描述

Three hundred aged(age>65y) patients were rondomized to acceleromyographic monitoring unit transcutaneous CO2 partial pressure(TcPCO2) monitoring(U group)or acceleromyographic monitering(T group)or conventional(C group).Anesthethic management was standardized.U patients were extubated when TOF ratio greater than 0.9 and transcutaneous CO2 partial pressure recover to preoprative (±5mmHg).T patients were extubated when TOF ratio greater than 0.9.C patients were extubated when standard criteria were met.Anesthesia monitoring, including ECG, invasive arterial pressure, pulse oxygen saturation, the BIS, nasopharyngeal temperature.The anesthesia induction with propofol 1 ~ 2 mg/kg, rocuronium 0.6 mg/kg, fentanyl 2 ug/kg, anesthesia maintained using propofol, fentanyl and the rocuronium 0.3 mg/kg. continuous pumping, maintain circulation stabilization and BIS value in 40 ~ 60, about 30 minutes before the end of surgery to stop rocuronium infusion, at the end of sewing leather to stop propofol and fentanyl infusion. Adjust Respiratory parameters, maintain breathe out co2 partial pressure at the scope of the 30 ~ 35 MMHG, using the variable temperature blanket insulation. All patients are monitored and give the muscle relaxant antagonists, pulling out endotracheal intubation, recording the TOF and TcPCO2 data when leaving the operating room . But during anesthesia management in group C, shielding TOF and TcPCO2 data to the anesthesiologists; T group during anesthesia management, shielding TcPCO2 data to the anesthesiologist; U set during anesthesia management, can according to the TOF and TcPCO2 data to management. All postoperative patients are sent into PACU, giving oxygen mask 3L/min, they can leave PACU Aldrete score nine points or more. By blind method principle, physicians of PACU,who is responsible for the patients with postoperative index records and statistics are blind to the staff for grouping, intraoperative management and BiBa tube drawing situation , in order to avoid bias. Statistical analysis: all the data represented as mean + / - standard deviation, using SPSS statistical software, measuring data comparison using analysis of variance between groups, count data using chi-square test, P < 0.05 that was statistically significant

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective general anesthesia surgery elderly patients (age > 65 years), gastrointestinal surgery

排除标准

  • ASA grade III or IV level, merging, bronchial asthma, chronic obstructive pulmonary disease, severe liver and kidney function is not complete (liver and kidney function corresponding biochemical index 50% above the normal level), neuromuscular disease, and use effect of neuromuscular transmission drugs or severe obesity (BMI > 35) of the patients

结局指标

主要结局

The comparison between groups of postoperative respiratory adverse events

时间窗: up to 24 month

次要结局

未报告次要终点

研究者

发起方
Beijing Municipal Science & Technology Commission
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaolei

The medical team leader

Beijing Municipal Science & Technology Commission

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