前几天在麻醉群里面看见《一份写给姚尚龙教授的信》，内容是这样的：
尊敬的姚尚龙教授，您好！我是XXX医院一名麻醉科医师，最近遇上一例产科麻醉纠纷，您是产科麻醉指南的组长，想和您讨教一下。24岁初产妇，68kg，5月22日中午12点多做的分娩镇痛，晚上8点左右宫口开全，做会阴侧切胎儿不能下来，晚9：15分改紧急剖宫产。因产科医生要求尽快，故来不及联合麻醉，在硬膜外导管加2%利多卡因10ml ，5分钟后切皮，产妇喊痛，静脉用丙泊酚80mg，病人安静，面罩加压给氧，9:32剖出一无心跳，呼吸的婴儿，经气管插管抢救，最终婴儿心跳恢复，但无呼吸，最终婴儿死亡。给丙泊酚后产妇并无低血压及缺氧发生。
医院和产科紧紧抓住丙泊酚时产科麻醉禁忌这一点，法官也抓住说明书问。我出示了产科麻醉指南，也出示了现代麻醉学产科麻醉一章，但法官认为所有的权威书籍和指南都要服从说明书。。。。。。最后判脐带脱垂主要责任，麻醉是次要责任。
疑问：
1、丙泊酚是否可以用于产科全麻？说明书上禁忌、产科麻醉指南上推荐的药物在临床上广泛应用如此案例引起纠纷我们到底应该怎么办？
2、如果大家做产科麻醉，遇到椎管内禁忌症又没有氯.胺.酮的情况下应该怎么办？请各位战友帮助解答，谢谢！
25-27,70，83楼已汇总几位专家意见，请关注！ 论坛助手
作者: 南京-辛哥 时间: 2015-6-13 12:21
参加过GCP培训的都应该知道，说明书内的内容是经过一二三四期临床试验，结合临床应用不断被修订的，超说明书使用本身存在比较大的不确定性。说明书外使用想最终正名，还是要落实到说明书上，其风险还是要在说明书上标注，进行严格限定。正如耐乐品可以明正言顺腰麻而其他罗哌卡因只能被一些地方小范围私下使用。药品上市是有严格的说明规范，经过层层过滤，一般情况下，按照药商给的方法使用，不会出事，而药品使用者的临床经验或口口相传相对于严格的上市标准显得无比苍白无力，法官相对医生本身就是非专业人群，当然只会尊重经过法定程序的说明书，而不是所谓的指南。
作者: 麻醉一生/娟 时间: 2015-6-13 13:16
很多不能椎管内麻醉的产妇，也是用丙泊酚的，这都是普遍现象了。！，那么以后全麻的产妇怎么做才好呢？
作者: 麻醉一生/娟 时间: 2015-6-13 13:18
剖腹产全麻能选择的药就是有限，很多时候宝宝出来有问题都说麻醉的问题，真的很无辜！
作者: hljhlj 时间: 2015-6-13 14:07
用依托咪酯吧，至少其说明书上写的是：孕妇及哺乳期妇女用药不推荐使用
作者: 袁波 时间: 2015-6-13 14:35
既然急诊手术硬膜外效果差，为什么不插管全麻？至少纯氧供应更具说服力！
作者: 麻醉一生/娟 时间: 2015-6-13 15:33
看看14年的专家共识怎么说的
153329pa5jzijy55y5jki9.jpg (190.22 KB, 下载次数: 115)
2015-6-13 15:33 上传
作者: hisue79 时间: 2015-6-13 15:37
怎么说呢？很多说明书上都不建议或禁止使用的麻醉药物在临床上也广泛应用，如左布，也用于腰麻。但中国就这样，不出事时尽管用，出事后就会鸡蛋里挑骨头。特别是麻醉前的访视很重要，一定要把好病人关，产科的在送入手术室后，麻醉前常规会听一下胎心的，如果原本就出现了胎儿宫内窘迫，术前产科医生就会跟家属交待好病情。麻醉医生，懂得保护自己很重要。
作者: lcrzl 时间: 2015-6-13 16:18
问题的焦点在于产科全麻是否能使用丙泊酚，而不是本病例中麻醉医生的选择是否正确。这个判例将很大程度影响产科全麻药物的选择范围和操作空间，这种影响可能会作用于整个行业，请大家三思。
作者: 张仕昌 时间: 2015-6-13 16:35
为了安全，硬膜外效果不好，还是叫产科医生局麻，小孩出来后再全麻，看他们还能怎么说？
作者: 菡菡 时间: 2015-6-13 16:36
不知道为什么我们用的丙泊酚说明书没有写禁用于产科麻醉
作者: 张仕昌 时间: 2015-6-13 16:41
其实这个产妇，丙泊酚可能对小孩一点影响也没有，但是没有办法，这就是中国，产科医生还不是他妈的那个鬼样，帮他排忧解难的时候她不说话，出了事情就推，要是小孩没有问题她们会叫紧急剖宫产，所以，我现在产妇进手术间，必须叫助产士听胎心，不管多急，先听再说，避免麻烦。
作者: 王朝阳 时间: 2015-6-13 16:49
应该预见到胎儿的危险性，如果有危险就不用
作者: 972630227 时间: 2015-6-13 17:32
看来用什么药己不重要了。什么重要喃？那就是麻醉医生还要努力的学习法律！法官们应到各医院向麻醉师普1去。
作者: ZSF 时间: 2015-6-13 17:33
既然能硬莫外何不腰麻，效果迅速确切。多不了几分钟。
作者: ZSF 时间: 2015-6-13 17:36
这种情款如胎儿缺氧就加局麻胎儿取后全麻，如没缺氧那就加药慢慢等，吧
作者: ZSF 时间: 2015-6-13 17:37
全麻要时间配合好，要用不能过台盘的药
作者: sunkaoyan81 时间: 2015-6-13 17:56
姚教授没看到？姚教授很为难！医疗是越干越迷茫，最后一帮述士决定了大夫的命运！以后怎麽麻呢？
作者: 黎想 时间: 2015-6-13 18:16
唉！又有多少人有勇气改行，只不过发发牢骚而已。
作者: 黎想 时间: 2015-6-13 18:20
干这一行看不到希望，就这样扔了奋斗那么多年的行业也有点不舍，就算舍得扔，也没有其他的技能可谋生。
作者: 张弓悦 时间: 2015-6-13 18:36
我们剖腹产做全麻，都是丙泊酚，芬太尼和万可松。新生儿评分没有区别。当然是医生手拿刀以后，才开始诱导。任何麻药都对孩子有影响。关键在人，如何把握用药时机，新生儿抢救也很关键。
作者: 小宇 时间: 2015-6-13 18:46
很矛盾的一个问题，纠结！我们也会使用，一般让产科医生先局麻切皮开始，准备取小孩了再给药，一两分钟小孩取出来，目前没有发现呼吸暂停的。可有的医生也不配合，那就只能碰运气了，想想还是满可怕的
作者: 小宇 时间: 2015-6-13 18:50
还发现很多说明书上说不能通过胎盘的药对胎儿还是有影响的。药就那么几种，不出事只要可控，啥都可以用，一出事就完了，所有的药都是禁忌！难呀，悲催的行当
作者: gongtw 时间: 2015-6-13 20:18
好想麻醉权威给出意见，或者他们怎么做的！惹上官司就等输嘛？或者看运气！
作者: xyz-cn99 时间: 2015-6-13 22:07
北京协和医院麻醉科朱斌教授：//@协和朱斌:这两段话是基于咨询两位致力于医疗纠纷律师（刘律师 and 张律师）意见的总结，非常感谢
药物的Off-label use在美国和许多国家的确并非非法，但使用时必须有明确专业指针。在我国有争议（即便是在医疗界），但已经近年来已经得到相当重视，逐渐得到主流法律界认可（药品说明书不能替代诊疗规范，不具有法律权威性）。的确，某时、某地出于政治因素，医疗界正当权益可能被漠视。
在我国现阶段，药物Off-label use最好满足三个条件：1基于询证医学，院内建立药物Off-label use使用目录，官方明确可以Off-label use的药物；2 Off-label use之前，其专业指针在病历上应该明确记录。3最好签署知情同意书（如果没有，可以用紧急避险作为事后理由）。建议该医生上诉。
作者: xyz-cn99 时间: 2015-6-13 22:08
北京安贞医院麻醉科卢家凯教授意见：
首先，感觉胎儿死亡和使用丙泊酚的因果关系不确定。其次，本案例再次反映了药品说明书与临床现实不相符带来的潜在风险。我认为，80mg丙泊酚静脉注射实施紧急产科全麻没有过错。新生儿出生时心跳呼吸停止，由产科问题等多因素共同造成可能性很大。实际工作中，产科及其他部分专科麻醉均存在临床实际不符合说明书的情况，这是个急需实际解释方案的临床共性问题。其他药物也有类似情况，只是丙泊酚用于产科全麻，由于各种因素的参与，当出现不良结局后更容易与之联系在一起。能否从专业学术机构的层面，提供一个出现问题时可以做为医师为自己辩护的权威条款，做为说明书更新前的补充？当然，这样的条款必须是十分严谨、局限和审慎的。
作者: xyz-cn99 时间: 2015-6-13 22:15
美国塔夫茨大学医学中心麻醉科赵培山教授：
1) 硬膜外给3%的氯普鲁卡因加碳酸氢钠起效比利多卡因快，大概3分钟内就能达到胸4水平，如果没有氯普，给10毫升2%的利多卡因量不够急诊剖宫产。要15～20毫升一次推入，要加8.4%的碳酸氢钠，加快起效，最近有综述报道，加芬太尼也可以加快起效。我一般是给100微克芬太尼。不会对胎儿有呼吸抑制。这在国内可能又要遭埋怨了。但是，硬膜外给100微克芬太尼，母体血液浓度是多少呢？有多少可以通过胎盘到胎儿呢？血液浓度是多少能引起呼吸抑制呢？
2) 80毫克丙泊酚对68公斤体重产妇不算过量。并且病人血压平稳，没有低氧。这个处理是正确的。但不知是否气管插管了，应该合用琥珀胆碱100毫克，加环状软骨压力6～8公斤，气管插管，保护气道。
3) 我们常用丙泊酚，没听说是产科禁忌，这个应该和药厂交涉，让他们说明禁忌的证据是什么，否则，应该修改说明书。国内还有硫噴托纳吗？我们早已没有了，这是产科以前的标准用药。如果有，以后可以用。
4)胎儿死亡和麻醉无关。从9：15到9：32是17分钟，一般来说，时间不算太慢，但这可能是5分钟剖宫产的情况，如果产科和麻醉科没有很好的沟通，麻醉科无法决定这个。从五分钟后(9：20)改全麻到9：32胎儿出生12分钟对急诊剖宫产来说时间太长了。只因为说明书的不妥，就赖麻醉是法官的无知。学会应该出面干预这个案子，否则，类似事件还会发生。
在美国有很多药物是 off label 应用，但这是大家约定俗成的标准治疗(standard of care), 临床证明也是安全的，包括丙泊酚，美国说明书上只说，不建议在孕妇中使用，但实际工作中，没有人不用。但国内 药物 off label的应用可能要通过麻醉学会咨询法律顾问后决定吧。
回答我第一点提出的问题：
硬膜外给100微克的芬太尼后，母体血液浓度为0.5~0.6 ng/ml。脐动脉与母亲静脉浓度比为0.3，也就是说，脐动脉浓度为0.2 ng/ml 左右。有研究表明新生儿全麻气管拔管时的血液芬太尼平均浓度为 0.4 ng/ml. 临床研究还显示，硬膜外给100微克芬太尼后，新生儿没有呼吸抑制，五分钟阿氏评分没有低于9的，脐带血pH没有低于7.2的。
芬太尼在产妇中的应用也是 off label.厂家说明书上不建议在产妇中使用。
作者: xyz-cn99 时间: 2015-6-13 22:22
微博-小夏微博初心者：
1.汲取教训，平时就严格按照药物说明书执行，养成习惯 2.不能光考虑让手术医生和病人满意，还要不伤害自己3.紧急时局麻4.持续胎心监护
微博-冬之寂静_HN：
产科医生在这里的表现实在令人不齿！麻醉科与手术科室本来应该是风险同担的共同体，关键时刻她们的行为不是承担却是出卖！既然她们不仁，别怪我们不义。她们在麻醉前、手术开始前有没有检测胎心？没有，就是她们的失职。有，当时是多少？有没有记录？为保护自己，以后剖宫产全麻宜谨慎使用依托咪酯。
作者: xyz-cn99 时间: 2015-6-13 22:35
微博-@Anesthetist-KUN:
所有的权威书籍和指南都要服从说明书，至少目前法律就是这么规定的，我们只能适应。是否可以用依托咪酯代替丙泊酚，毕竟说明书写的是不推荐而不是禁用。这个病例产科明知原因是脐带脱垂还推脱责任到麻醉，下次类似情况让他们局麻剖宫产！
作者: 心护生命 时间: 2015-6-13 23:23
基层医院就那几种药，按说明书好多病人都应该转院，这让人咋弄啊。
作者: longxiang5566 时间: 2015-6-13 23:42
这种病例我也碰见过，2年前，周日中午12点左右，一名26岁产妇急诊剖宫产，这个病人首先考虑顺产，在产房有些紧张，产科医生给了20毫克安定（应该是分2次给），之后就开始烦躁，有点谵妄状态，入手术室是由4个家属按着来的，椎管内麻醉已经不能配合啦，在这种情况下，先叫上级医生，然后建议产科医生做局麻切皮，然后给予氯.胺.酮40毫克，面罩给氧，等结扎脐带后用舒芬，维库，丙泊酚，插管全麻，患儿开始评分7分，5分钟后10分，不过羊水粪染，送新生儿病房，孕妇术后快速苏醒，拔管，平稳，送病房。但新生儿第二天凌晨6点呼吸心跳停掉，没抢救过来。我考虑是患儿缺氧性脑病，脑水肿，脑疝形成。这个病号我真是捏了一把汗才做完麻醉，在麻醉签字前，谈到了一些药物可能影响新生儿，事后也是扯皮，往麻醉这边扯，本来想整理一下分享的，毕竟有纠纷就算了。请教同行高手，这种情况，怎么处理更合理些。
作者: 醉心草2014 时间: 2015-6-14 00:25
产科医生为什么要给安定呢！它可是会通过胎盘屏障进入胎儿体内
作者: 钦差大臣 时间: 2015-6-14 06:49
看后无语，我们的专家讲了很多，到最后还不如一个小法官一句话。我们该怎么办？亲们
作者: 帅哥 时间: 2015-6-14 09:43
心情很复杂。我建议：
1 产科麻醉前一定要求产科医生跟家属讲清楚-“现在很危急，小孩情况不好”之类的告知义务（最好有录音）在签同意书；
2 麻醉医师同样在同意书签字时讲类似-“现在很危急，小孩情况不好，需要紧急麻醉手术，风险很大，有可能小孩保不住。。。。。。（最好有录音）我们将尽力而为”再签同意书。
3 特殊情况，就局麻手术。看看大家是否同样我的观点？
作者: herohu 时间: 2015-6-14 10:25
麻醉真是不好干，我们这边只要是小孩出来不是很好的话，就说是麻醉的问题，病人的血压没有控制好，产妇的特殊生理情况，就是容易出现低血压。我现在也是很迷茫，产妇一过性的血压下降，能对新生儿产生多大的影响？至于会出现呼吸不好吗？
作者: wm1730 时间: 2015-6-14 12:03
之前无痛分娩留了管
作者: maxj1985 时间: 2015-6-14 13:13
看人下药，没担当，不负责任的产科医生一律局麻
作者: maxj1985 时间: 2015-6-14 13:16
保护好自己才能去保护病人
作者: Txy200610 时间: 2015-6-14 14:25
同意！我们碰到这种紧急情况也会这么做！
作者: zenglizhi 时间: 2015-6-14 15:19
菡菡 发表于 2015-6-13 16:36
不知道为什么我们用的丙泊酚说明书没有写禁用于产科麻醉
你们用的哪个厂家的丙泊酚
作者: leilei1219 时间: 2015-6-14 15:26
为什么没有人讲用吸入麻醉呢？我们医院如果产科全麻，基本上是用七氟醚诱导，入睡后，肌松，插管，孩子出来后，关醚，丙泊酚瑞芬泵入直到手术结束。
作者: zenglizhi 时间: 2015-6-14 15:35
herohu 发表于 2015-6-14 10:25
麻醉真是不好干，我们这边只要是小孩出来不是很好的话，就说是麻醉的问题，病人的血压没有控制好，产妇的特 ...
我们这边也是，明明是自己的问题小孩出的慢了就怨紧了，孩子出来缺氧，就能和产妇麻醉中一过性低血压联系起来，反正先赖出去再说
作者: 小小麻针 时间: 2015-6-14 17:13
西安力邦生产的力蒙欣说明书是这样写的：妊娠期间不应使用丙泊酚注射液，但在终止妊娠时可以使用丙泊酚注射液。不知你科使用的是哪个厂家的？
作者: zhongjue5086 时间: 2015-6-14 19:23
给那么大量安定？我也是醉了。
作者: soo2007 时间: 2015-6-14 20:39
要是都按照药品说明书，那我们还学药理学干什么~
作者: xxxinyue 时间: 2015-6-14 20:50
养成好习惯，我们院常规麻醉前或者切皮前一定要听胎心
作者: xxxinyue 时间: 2015-6-14 20:53
这种事在平常是多常见啊
作者: THESEVENTHS 时间: 2015-6-14 21:06
发挥医生的主观能动性，以后医生完全按照说明书，这样估计……哎
作者: sxq6899 时间: 2015-6-14 21:16
翻看了国内外五六种丙泊酚的说明书，确实不主张用于产科手术，看来还是老办法好，氯.胺.酮或者七氟烷诱导适用于从低端到高端的产科全麻。
作者: xxxinyue 时间: 2015-6-14 21:20
患者喊痛，使用丙泊酚？有镇痛作用？
作者: xxxinyue 时间: 2015-6-14 21:22
起码也是处理不当吧
作者: zhoubaohong 时间: 2015-6-14 21:22
保护好自己才能去保护病人
作者: xxxinyue 时间: 2015-6-14 21:22
如果出现纠纷，你们这样的用药百分百全责
作者: zhoubaohong 时间: 2015-6-14 21:22
美国已经在小儿上用丙泊酚了
作者: xxxinyue 时间: 2015-6-14 21:24
那是得普利麻，而且是在有气道管理的情况下才能使用
作者: 随枫飘 时间: 2015-6-14 21:28
期待国家规范药物的临床试验,国外各年龄段能用的药物,在国内生产的因加强各年龄段临床试验,加大临床试验投入,让我们用有所依,而不是我们自己临床医师试验的用,没有依据,也没有告知患者及家属。大家想想，用用药前大家告知患者及家属，我估计患者及家属没有哪个是同意用的，谁愿意拿自个给医学用来试验，一点报酬也没有。本来应做的临床试验，药厂是要做的，要出钱的，要投入的。现在是本该应有的临床试验，能不做就不做了。由临床自个去用吧，出了事了。是用那个人的事哦。不关相关部门的事。这就是中国。
作者: 月夜枫 时间: 2015-6-14 22:36
虽然丙泊芬没有镇痛作用。但是，你能只用50ug芬太尼做完无痛胃肠镜甚至是无痛人流吗？既然丙泊芬没有镇痛作用，那就不用好啦！
作者: 宁波小兵 时间: 2015-6-14 23:02
丙泊酚产科禁用 可终止妊辰时可以 两者意思不同 剖宫产应该属于终止妊辰 丙泊酚可用 不过我认为指南跟说明书有冲突时应该以说明书为准 个人理解
作者: hutaishan 时间: 2015-6-15 07:58
我们还是请姚教授来回答这个问题吧
作者: xxxinyue 时间: 2015-6-15 08:08
这种情况肯定是改善镇痛啊，如果不是饱胃，可以辅助吸入七氟醚待毛毛出来后立即改全麻
作者: 人狗情 时间: 2015-6-15 08:09
我们的论坛里为什么很少有权威专家出来给大家释疑呢？
作者: hljhlj 时间: 2015-6-15 08:17
本帖最后由 hljhlj 于 2015-6-15 08:29 编辑
说明书的问题关于孕妇：
1、得普利麻中写的是孕妇禁用
2、力蒙欣写的是不宜使用
说明书的问题关于儿童：
1、得普利麻不推荐3岁以下小孩用
2、静安则写的不用于1个月以下小儿的全身麻醉及16岁以下重症监护患儿
这得请大佬们出来说道说道到底：按照指南上用药时与说明书上的禁忌相冲突时该怎么办？如果要保守医疗那最好不用，直接给吸入七氟烷和肌松药插管，插管时病人难受、血压波动但不至于惹上官司。法官也不懂医学专业，他们当然按照说明书上判案了。
这真需要象罗哌卡因能否用于腰麻（除了耐乐品的说明书可以外其他厂家的说明书都没明确，但最后麻醉届的大佬最后还是让大家按照说明书使用）一样给大家一个明确的用法
作者: qiongqiong 时间: 2015-6-15 09:35
但是剖宫产本身就是种终止妊娠的方法，这个不涉及违规吧
作者: huyaojianhai 时间: 2015-6-15 10:04
http://www.dxy.cn/bbs/topic/28029113?keywords=桑兰
作者: huyaojianhai 时间: 2015-6-15 10:05
桑兰全麻下剖宫产术
作者: yuhbyuhb 时间: 2015-6-15 10:22
是啊，我觉得麻醉好多药品的说明书也好乱啊，比如舒芬太尼、瑞芬太尼等药明确写了，重症肌无力患者禁用，都不知道这类患者用什么药做麻醉
作者: 杨麻哥哥 时间: 2015-6-15 16:29
吸七氟烷时难到不是全麻？
作者: wanglei1108 时间: 2015-6-15 17:20
中国的母亲很伟大的。。可以考虑让他局麻取出孩子再考虑全麻的。为什么要给丙泊酚？
作者: 论坛助手 时间: 2015-6-15 21:06
华中科技大学武汉同济医学院附属协和医院麻醉科姚尚龙教授意见：
新青年论坛转发的关于产科麻醉用药的帖子最近引起热议，仔细研读后，其中提到的一些问题值得大家思考。
首先，产科麻醉指南中关于使用丙泊酚的态度并非推荐其用于产科麻醉，而是相当审慎的，指南中指出，药物说明书强调其不宜用于产科麻醉；亦指出有报道认为丙泊酚用于剖宫产有优点，但存在争论，目前的倾向性建议为产科麻醉使用丙泊酚应慎重！
指南中说明，产科麻醉的全麻药物选择以氯.胺.酮为宜，依托咪酯、吸入麻醉药也可考虑作为候选药物。
关于大家重点关注的丙泊酚off-label use问题，药物说明书的修改需要可靠的循证医学数据支撑来推动，进一步增加药物临床实验数据，这些也正是中华麻醉学会高度重视和积极推动的。在说明书未修改前，建议大家还应慎重用药。
超适应症用药始终存在风险，能够不用就不应使用！临床必须使用前，充分告知患者和家属很有必要的。举个例子，在耐乐品刚进入中国不久，部分麻醉医师就超适应症应用于腰麻（其最初说明书并无腰麻适应症），近十年后其说明书才加入腰麻适应症，其实是中国的麻醉医师冒着巨大的个人风险在免费做着先期临床试验！这种局面并非我们希望看到的。
就这一病例而言，该名患者分娩镇痛数小时，未能分娩成功改行急诊剖宫产，意味着患者或胎儿存在紧急状况。麻醉医师在麻醉前应充分告知患者和家属，麻醉过程中母婴存在较大风险，包括用药！
这一情况下，麻醉前后对胎心进行监护，评估胎儿状况是十分关键的。在我院，产科医师须在麻醉实施前后监测胎心，以判断胎儿状况。若该病患在实施麻醉时未作相应的胎心监测，意味着麻醉医师承担着相当的风险。该名患者麻醉中，可考虑继续追加局麻药物观察麻醉平面，或辅以适量氯.胺.酮，待镇痛完善后再继续手术；若病情紧急，采用其他静脉麻醉药实施全麻或立即辅以局部浸润麻醉完成手术也是可行的。
改变药物说明书并非能一蹴而就，临床麻醉中风险也是无处不在，期望麻醉医师能够时刻警惕，保护好自己，才能更好保护患者安全。
作者: 叶舞天1 时间: 2015-6-15 21:16
说得到是实话
作者: wfmzlaolang 时间: 2015-6-16 09:49
得普利麻说明书不建议一个月内新生儿。大于1月可以用于诱导和维持
作者: 医言九鼎 时间: 2015-6-16 11:05
所以有新生儿科最好，抢救必须儿科医生做
作者: wanghe1110 时间: 2015-6-16 13:02
huyaojianhai 发表于 2015-6-15 10:05
桑兰全麻下剖宫产术
桑兰还用得着大麻醉吗？感觉多此一举
作者: huyaojianhai 时间: 2015-6-16 16:01
wanghe1110 发表于 2015-6-16 13:02
桑兰还用得着大麻醉吗？感觉多此一举
先去丁香园看看帖子
作者: dr.zhang 时间: 2015-6-16 16:49
论坛助手 发表于 2015-6-15 21:06
华中科技大学武汉同济医学院附属协和医院麻醉科姚尚龙教授意见：
新青年论坛转发的关于产科麻醉用药的 ...
这个学习了，也遇到类似的情况，但是好在母亲和胎儿都比较健康，看了这个帖子后背汗都下来了，想想都后怕啊。还是按照说明书上来吧
作者: myw007 时间: 2015-6-16 17:36
本帖最后由 myw007 于 2015-6-16 17:39 编辑
说一下我的观点：你们这种讨论根本没必要，首先要搞清一件事：任何人、任何事都要在法律的架构下，医学更是如此，否则我们和巫婆没有区别（别以为你用的是科学），不在此架构下根本不必讨论医学技术问题，这是战略和战术的区别，哪么依法办事是否难呢？我看不见得，就两条凡是要说明（我们现在有些人老是以为自己是专家，和病人（家属）几乎没几句话，这非常不好，要认识到你的工作对象是人，不是一个零件）、留证据；要根据法定文件办。否则你就必然碰壁。
作者: vividhu 时间: 2015-6-16 20:04
地佐辛能用于硬膜外吗？
作者: vividhu 时间: 2015-6-16 20:10
舒芬能用于产科的术后的镇痛吗？会影响喂奶吗？
作者: 朱晓军 时间: 2015-6-16 21:41
我想问问姚尚龙教授，你们医院像这种急诊胎儿宫内窘迫的患者如何全麻？有没有规范？如果规范与说明书相冲突，麻醉学会会承担什么样的责任？祥子站长请帮我问问。谢谢！
作者: mzkzlm 时间: 2015-6-16 21:50
之前遇此情况也有用过，还好没出事，过来像大佬们学习
作者: panda5976 时间: 2015-6-16 22:05
本帖最后由 panda5976 于 2015-6-16 22:14 编辑
法官认为所有的权威书籍和指南都要服从说明书。。。。。。最后判脐带脱垂主要责任，麻醉是次要责任? 患者麻醉中，可考虑继续追加局麻药物观察麻醉平面，或辅以适量氯.胺.酮，待镇痛完善后再继续手术；若病情紧急，采用其他静脉麻醉药实施全麻或立即辅以局部浸润麻醉完成手术也是可行的。
作者: 论坛助手 时间: 2015-6-16 22:43
华中科技大学同济医学院附属协和医院麻醉科张诗海教授：
指南的制定，只是供临床者以参考，绝对不是金科玉律。如果是金科玉律，就不需要更新了。指南经常更新，就是因为有些研究不按指南做却结果更好。总体而言，指南的作用く医院规定く科室常规。就丙泊酚是否可用于产科麻醉，我有一点儿经历。我曾有幸到美国儿童医院排名第一的费城儿童医院学习。我问麻醉科主任Shwartz教授:说明书说很多药物不能用于小儿，贵科如何看待这个问题？Shwartz教授回答:如果按照说明书，儿科麻醉将无药可用，我们只用我们认为对患儿有益的。
中国对患者的保护到了过分的程度，这种过分加在医生的头上导致医师畏手畏脚，最终受害的是病人。就本例而言，就是就医大环境不好造成的，与什么说明书和指南无关。就是没有说明书和指南的问题，患者一定会找到其他理由告你，如果他/她想告你的话。
作者: 且子 时间: 2015-6-16 23:06
国情使然，谁碰到谁倒霉。只能祈祷了。
作者: 杨麻哥哥 时间: 2015-6-16 23:57
现在好多医院没氯氨酮了！悲催了
作者: 杨麻哥哥 时间: 2015-6-16 23:59
麻醉科就是用来背黑锅的！
作者: zyg0313 时间: 2015-6-17 07:24
作者: wanghe1110 时间: 2015-6-17 13:37
huyaojianhai 发表于 2015-6-16 16:01
先去丁香园看看帖子
受教，谢谢
作者: 小麻草 时间: 2015-6-17 16:21
安定在产科是可以给的，主要是调整宫缩软化宫颈。
作者: xgw1968 时间: 2015-6-17 21:59
我个人的观点，剖宫产全麻不是异丙酚不能用。发生这样悲剧的事情只能认倒霉。主要还是产科医师在剖宫产前没有进行胎心音听诊，也许还没有麻醉胎儿已经没有了胎心音了。再者麻醉者应该具备新生儿复苏的相关知识。楼主求助产科学组的原因是希望中华麻醉学会给予帮助。
作者: gzzhanhaibo 时间: 2015-6-17 22:13
是哪个厂家的Propofol，是不是不同商品名的Propofol说明书不一样，写产科麻醉禁忌太过分，换其他牌子的，说明书写个产科麻醉慎用，打官司也好点啊
作者: zhongjue5086 时间: 2015-6-17 22:56
安定入胎盘屏障，量大对胎儿有影响，而且文中用法主要是用来镇静，而不是用来软化宫颈口我。
作者: zhangzhhui 时间: 2015-6-18 08:18
现在还有氯.胺.酮吗？，氯.胺.酮其实是特别好的药可惜买不到了。
作者: zhangzhhui 时间: 2015-6-18 08:24
遇到这种情况，坚决局麻做手术，无论产科怎么辩解，反正我没有进行操作，责任就不会是麻醉科担主要责任。总之中国医生的职业环境的恶劣不知还要持续多长时间。
作者: 朱晓军 时间: 2015-6-18 09:29
那是因为找到明显的把柄了。如果你用了氯.胺.酮、依托咪酯或笑气加七氟烷，他们也有话可说，你这是全麻药，就有可能导致新生儿麻醉和窒息。反正在中国，你制定的指南权威性还不如药物说明书。如果你不用任何麻醉药，由产科医师局麻，也有话可说——局麻松弛度不够，取胎困难，导致胎儿缺氧加重（产科不会说她们的切口一贯小的），而且因局麻抽药和注射局麻药延误抢救时机。我靠，左右不是人，反正死定了。大佬们是不需要亲自做麻醉的，小民遭殃罢了。
作者: xjp96 时间: 2015-6-18 15:09
wanghe1110 发表于 2015-6-16 13:02
桑兰还用得着大麻醉吗？感觉多此一举
截瘫病人必须给麻醉！
作者: 御书 时间: 2015-6-18 19:30
这种情况曾经开个会议听说过，法院肯定是以说明书为准的。所以以后用药还真是小心哪
作者: 朱晓军 时间: 2015-6-18 22:31
中国的医生怎么这么悲哀！无药可用，还要给他医。
作者: Anesthesiolo 时间: 2015-6-18 23:01
本人有以下几点提出讨论：
1.胎儿不会无缘无故出现心跳骤停，本病例提供的资料是否为真实情况？
2.紧急剖宫产建议麻醉前让产科医生再次确定胎心情况，本例如排除麻醉原因，在实施麻醉前或切皮前胎心已经明显抑制，与后者使用麻醉药物无关；
3.使用丙泊酚后是否有产妇缺氧或低血压发生？80mg是否可靠？ 推注速度？如何判断产妇缺氧？面罩加压给氧不符合产妇全麻---RSI原则，返流误吸？是否使用了其他阿片类药物？隐瞒情况？丙泊酚全麻是标准做法，我本人曾经有近百列产科全麻醉经验，在标准剂量下与胎儿预后无关。
Rapid sequence induction using propofol and rocuronium should become the standard for general anaesthesia in the obstetric patient. Short-acting opioids are still not given routinely but should never be withheld in case of severe preeclampsia. Cricoid pressure can only be accurately performed by trained caregivers and should be released if intubation appears to be difficult. Supra-glottic airway devices may safely be used in fasted, nonobese elective caesarean section, but endotracheal intubation remains the gold standard, especially in emergency caesarean section in labouring women. Both sevoflurane and propofol are appropriate for the maintenance of general anaesthesia during caesarean section. Awareness remains a major concern in obstetric anaesthesia.
作者: Anesthesiolo 时间: 2015-6-18 23:27
BMC Anesthesiol. 2015; 15: 63.
Published online 2015 Apr 29. doi: 10.1186/s12871-015-0044-6
PMCID: PMC4419384
Effects of propofol versus thiopental on Apgar scores in newborns and peri-operative outcomes of women undergoing emergency cesarean section: a randomized clinical trial
Janat Tumukunde,corresponding author Dlamini Diana Lomangisi, Ocen Davidson, Andrew Kintu, Ejoku Joseph, and Arthur Kwizera
Author information ► Article notes ► Copyright and License information ►
Go to:
Abstract
Background
General and regional anesthesia are the two main techniques used in cesarean section. Regional anesthesia is preferred, but under certain circumstances, such as by patient request and in patients with back deformities, general anesthesia is the only option. Commonly used induction agents include thiopental, ketamine, and propofol, depending on availability and the maternal clinical condition. The objective of this study was to investigate the effects of thiopental and propofol on the neonatal Apgar score and maternal recovery time following emergency cesarean section in order to determine the superior agent for mothers and neonates.
Methods
This single-blinded randomized clinical trial included 150 ASA I and II patients block-randomized equally between the two study arms. Pregnant women at term scheduled to undergo cesarean section and their neonates were enrolled. The primary outcomes were the Apgar scores through 10-min postpartum, resuscitation requirement, and admission to the neonatal intensive care unit. The secondary outcome was the maternal recovery times.
Results
At 0 min (umbilical cord clamp time), 43 (57.3%) neonates in the propofol group had an Apgar score < 7 compared with 31 (41.3%) neonates in the thiopental group (p = 0.05). The maternal recovery time was shorter in the propofol group than in the thiopental group (25 min vs. 31 min, respectively, p = 0.003).
Conclusion
Apgar scores do not differ significantly whether thiopental or propofol is used for anesthetic induction in women undergoing general anesthesia for an emergency cesarean section.
Trial registration
Pan-African Clinical Trial Registry (#PACTR201306000536344) http://www.pactr.org/ATMWeb/appm ... ortal_page_mytrials
Keywords: Propofol, Thiopental, General anesthesia, Cesarean section, Apgar score
Go to:
Background
Regional anesthesia is generally preferred during cesarean section, but general anesthesia may be the only option under certain circumstances such as patient preference, back deformities not amenable to spinal anesthesia, failed spinal anesthesia, intracranial hypertension, maternal coagulopathy, and certain neurologic diseases [1]. A safe induction agent for obstetrics should, among other things, provide a smooth, quick induction, maintain maternal hemodynamic function, and exert minimal to no effect on the Apgar score. Thiopental has been routinely used as an anesthetic induction agent for cesarean section since the 1930s and is the standard against which all new agents are compared. However, it has several disadvantages, including decreased maternal arterial pressure, which, when coupled with a long induction time, can reduce the Apgar score [2]. Propofol is widely used for induction and maintenance of anesthesia in other surgeries but not in obstetric procedures. It has a short induction time and blunts airway reflexes during laryngoscopy; compared with thiopental, patients emerge faster from propofol anesthesia [3]. However, propofol also crosses the placenta [4,5] and thus, can depress the fetal central nervous system, resulting in a low Apgar score at birth [6,7].
The population of pregnant mothers requiring cesarean section either by default or by request is rising, [8] and the lack of skilled labor in Uganda is a constant problem [9]. Maternal and child health is the focus of millennial development goals 4 and 5, and improving safety and reducing maternal and neonatal mortality are necessary to achieve these goals. Therefore, the objective of this study was to investigate the effects of thiopental and propofol on the neonatal Apgar score and maternal recovery time following cesarean section.
Go to:
Methods
Study design and setting
This randomized single-blinded clinical trial was performed at Mulago Hospital, which is the main national referral hospital in Uganda. Its obstetric department receives mothers from Kampala and the surrounding region. Approximately 30,000 deliveries are performed annually and 600 cesarean sections monthly, of which 15% are performed under general anesthesia. The high rate of general anesthesia for cesarean sections is due to the erratic availability of spinal needles and drugs, and unfounded patient fears over lumbar punctures in general. Anesthesia is performed by anesthesiologists, anesthetic officers, or postgraduate students in anesthesia.
Study population
We included ASA class I and II term pregnant mothers scheduled to receive general anesthesia for an emergency cesarean section and excluded all patients potentially allergic to propofol or thiopental.
Randomization, blinding, and enrollment
Participants were block randomized into the two study arms. An independent statistician randomly generated the sequence of participant allocation to the thiopental or propofol treatment groups. First, random blocks of 4–10 participants were generated, and within each block, a random sequence for the participant intervention groups was generated and labeled either 1 (one) for propofol or 2 (two) for thiopental. This sequence was concealed from all participants by inserting it into opaque, sequentially arranged sealed envelopes. The intervention group allocations were placed in small envelopes that were then placed in bigger envelopes representing the blocks. At the time of participant recruitment, the study investigator retrieved the next available small envelope, which indicated the intervention group, from the next available block envelope and handed it to the participant.
The patient, midwife, and pediatrician were blinded to the group assignment, but the anesthesia provider was not. The anesthesia providers were either qualified anesthesiologists or residents in their final year of residency. After screening for inclusion and exclusion criteria, eligible women were consecutively enrolled in the study.
Sample size
This was a non-inferiority study. To determine whether a 20% difference in the Apgar score existed between thiopental and propofol treatment, 150 patients were required to be 90% certain that the upper limit of a one-sided 95% confidence interval (or a 90% two-sided interval) excluded a greater than 20% difference in favor of the standard (thiopental) group.
Intervention and anesthetic technique
Each patient was wheeled into the surgical suite in a left lateral position and transferred to the operating table, and a wedge was placed under the right hip to achieve a leftward uterine displacement of 15°. Routine monitors were attached (pulse oximeter for heart rate and oxygen saturation, continuous ECG monitor, and automatic blood pressure monitor). A wide-bore intravenous cannula (16- or 18-G) was placed in the less dominant forearm for administration of drugs and fluids. Intravenous metoclopramide (10 mg) and ranitidine (50 mg) diluted in 20 ml of saline was administered over 2 min. The surgical site was then scrubbed and draped aseptically by the surgeon. Denitrogenification with 100% oxygen was performed for 3 min, and lignocaine (1–2 mg/kg) was administered to blunt the laryngeal reflexes and numb the catheterized vein to the nociceptive effects of the induction drugs. The induction agent was administered, either propofol (2 mg/kg) or thiopentone (4 mg/kg) depending on which study arm the patient was enrolled in, cricoid pressure was applied, and suxamethonium (1.5 mg/kg) administered. Using a laryngoscope, tracheal intubation was performed, confirmed, and secured within 2 min. The patient was maintained on isoflurane (1–1.5%) mixed with 100% oxygen flowing at 2.5 L/min until the start of skin closure. Nitrous oxide and ambient air were not used as these agents are unavailable at this hospital.
Oxytocin (5 IU) diluted in 5 ml of saline was administered as a slow bolus after delivering the baby’s shoulders. Pain was controlled by administering 0.1 mg/kg of morphine after the baby’s umbilical cord was clamped. Rectal paracetamol was also administered at the end of the procedure. All patients received 1,500 ml of crystalloids (normal saline or lactated Ringer’s solution). If hypotension, which was defined as a 20% reduction from the baseline blood pressure, was encountered, then additional crystalloids and vasopressors were administered at the discretion of the anesthesia provider.
Primary outcomes
The neonatal Apgar score was assessed and recorded at 0, 1, 5, and 10 min after the umbilical cord was clamped by the midwife. The requirement for resuscitation and admission into the neonatal special care unit (NICU) was also recorded by the study assistant. Criteria for NICU admission was any neonate requiring more than 3 min of continuous bag mask ventilation during resuscitation as per NICU protocols.
Secondary outcomes
The maternal recovery time was measured, defined as the duration from induction to complete orientation in time, place, and person.
Data management
All data were double entered into Epidata version 3.1 software, with range, consistency, and validation checks embedded to aid data cleaning. The data were analyzed using Stata version 12 software.
Categorical data, including the number of participants and the respective proportions, are presented in tabular, graphical and text forms, and categorized into propofol and thiopental groups. The two groups were compared using the Chi square test. Continuous data are presented as the mean with standard deviation, and were compared between the groups using the t-test to detect any significant differences. The median and interquartile range of the decision-to-delivery interval was calculated, and the differences between the groups were determined using non-parametric testing. A p-value of < 0.05 indicated statistical significance.
An intention-to-treat analysis method was used, and the main outcome of interest was an Apgar score of less than 7. The Poisson regression model was used to assess the incidence risk of the outcome between the two randomization groups and to estimate the risk ratio and confidence interval. Baseline characteristics were equally distributed between the randomization groups, and none of the outcomes differed significantly between the randomization groups. Therefore, multivariate analysis for potential confounders was not performed.
Data safety management board
The Data Safety Management Board (DSMB) comprised an anesthesiologist, statistician, obstetrician, and a pharmacist who were informed if an adverse event occurred. The study would be discontinued if 10% of study subjects in one study arm experienced an adverse event associated with the study drugs as determined by the DSMB, or if a p value of <0.025 was obtained on an interim analysis performed 3 months after beginning the study.
Ethical considerations
This study was approved by the Department of Anesthesiology, Mulago Hospital Ethics Committee, the School of Medicine Research and Ethics Committee (SOMREC), and the Department of Obstetrics and Gynecology. All patients provided informed, written consent before the start of surgery. This trial is registered in the Pan-African Clinical Trial Registry (#PACTR201306000536344).
Go to:
Results
A total 150 pregnant women were enrolled from November 2013 to April 2014 as shown in Figure 1.
Figure 1
Figure 1
Summary of patient recruitment and allocation.
Maternal baseline characteristics
Maternal baseline characteristics were equally distributed between the two study groups. The mean maternal age in the propofol and thiopental groups was 25.2 years and 24.2 years, and the mean weight was 68.6 kg and 66.7 kg, respectively. The median overall decision-to-delivery interval was 137.5 (IQR 20–968), and there was no statistically significant difference between the median intervals in the propofol (median 145; IQR 20–600) and thiopental (median 120; IQR 26–900; p = 0.540) groups. The induction-to-delivery interval and the surgical duration also showed no significant differences between the groups (Table 1).
Table 1
Table 1
Maternal baseline characteristics
Apgar score distribution
A total 74 neonates had an Apgar score < 7. Of those, 43 were in the propofol group and 31 in the thiopental group, with an incidence ratio of 1.42 (95% CI = 0.88–2.32) and a p-value of 0.068.
At 0 min, 43 (57.3%) neonates in the propofol group had an Apgar score < 7, compared with 31 (41.3%) neonates in the thiopental group. At 1 min, 35 (46.7%) and 24 (32%) neonates had an Apgar score <7 in the propofol and thiopental groups, respectively. At the 5-min mark, 13 (17.3%) and 8 (10.7%) neonates had Apgar scores < 7 in the propofol and thiopental groups, respectively, while at the 10-min mark, 3 (4%) neonates in the propofol group and 2 (2.7%) in the thiopental group had an Apgar score < 7.
The incidence of neonates with an Apgar score < 7 at each interval is summarized in Table 2. There were no statistically significant differences at any of the time points, except at time 0, which had a marginally significant difference (p = 0.05). The proportion of neonates with an Apgar score < 7 gradually decreased and did not differ significantly between the groups at 10 min. The trends are further detailed in Figure 2.
Table 2
Table 2
Percentage of neonates with an Apgar score < 7 post-cesarean section
Figure 2
Figure 2
Percentage of neonates with a postpartum Apgar score < 7.
Neonatal intervention and NICU admission
Maneuvers to improve Apgar scores included gentle stimulation or active resuscitation, which could be brief or prolonged. In total, 14 of 74 neonates born with an Apgar score < 7 required gentle stimulation to raise the Apgar score > 7. Of these, seven were in the propofol group and seven in the thiopental group. The remaining 60 neonates required active resuscitation including stimulation, bag mask ventilation, Laryngeal Mask Airway or endotracheal tube insertion, and ventilation, which was discontinued once the neonate demonstrated adequate spontaneous respiration. A total 19 (52.8%) neonates with an Apgar score ≤ 7 recovered (improved Apgar scores) after < 5 min of resuscitation in the propofol group compared with 12 (50%) neonates in the thiopental group. Additionally, 1 (2.78%) neonate in the propofol group and 2 (8.33%) in the thiopental group died. As per protocol, any neonates with low Apgar scores who required continuous bag mask ventilation for >3 min were admitted for close observation for at least 24 hours.
A total 22 neonates were admitted into the NICU for close observation, comprising 16 (21.33%) neonates from the propofol group and 6 (8%) from the thiopental group. Of these, 2 (13.3%) neonates in the propofol group continued to have an Apgar score < 7 (Table 3).
Table 3
Table 3
Neonatal resuscitation
Maternal recovery time
The mean recovery time was significantly shorter in the propofol group (25.1 min) than in the thiopental group (31.4 min; p = 0.003).
Go to:
Discussion
We conducted a single blinded randomized clinical trial comparing the effects of propofol and thiopental on neonatal Apgar scores and maternal peri-operative outcomes.
The Apgar scores of neonates randomized into the two study arms did not significantly differ, except at 0 min, which showed a marginally significant difference. However, the percentage of neonates with unsatisfactory scores (<7) was greater than 50% in the propofol group (57.3%) compared with that in the thiopental group (41.3%). While this may not be statistically significant, this outcome cannot be ignored because it highlights the need for skilled labor to attend all births when anesthesia is induced with propofol. The high prevalence of unsatisfactory Apgar scores can be attributed to the high rate of placental transfer of propofol coupled with the rapid loss of consciousness, as reported in previous studies [5,10].
The percentage of neonates with an Apgar score < 7 at the 1, 5, and 10-min intervals steadily decreased in both study groups to nearly equal numbers of three and two neonates in the propofol and thiopental groups, respectively (Figure 2). None of the differences in the Apgar scores were significant between the two groups, except at 0 min, which showed borderline significance, despite the Apgar scores being higher in the propofol group than in the thiopental group (Table 2). This finding is consistent with those of other studies comparing these two induction agents [11-13]. The faster improvement in the Apgar scores in the propofol group is probably caused by the fast redistribution half-life of propofol, which is as low as 1 min [14-16], while thiopental requires up to 6 min [17]. This also explains the higher percentage of neonates who recovered in <5 min in the propofol group.
An important finding in our study was the significantly higher rate of NICU admissions in the propofol group compared with the thiopental group. All but three neonates admitted to the NICU survived at 24 hours.
The three neonates that died in this study had low Apgar scores coupled with poor respiratory effort; they required ventilator assistance, but because these services were unavailable in the NICU, they died. A large percentage of neonates were admitted into the NICU (22% overall) not only because of low Apgar scores, but also due to protocol. All neonates with low Apgar scores requiring continuous bag mask ventilation for >3 min are admitted for close observation for at least 24 hours.
The mean recovery times were significantly shorter in the propofol group than in the thiopental group at 25 min (10.13) versus 31 min (14.66), respectively (p = 0.003). Because the mean duration of isoflurane exposure was identical in the groups (38.9 vs. 38.1 min), the prolonged recovery time in the thiopental group can be solely attributed to the induction agent. Contribution from the initial maternal physiologic state cannot be discounted; however, under normal circumstances, this factor should be evenly distributed between the two study groups as the study population was randomized.
Our study had a number of limitations. This was a single-blinded study because of the consistency of the drugs evaluated; propofol is a white, milky suspension, and thiopental is a yellow, clear solution. The anesthesia providers are aware of this difference; therefore, blinding them is impossible. Any individual variation in the metabolism of the induction drugs could not be measured; thus, this potential contribution to the low Apgar scores could not be accounted for. Finally, the interval between the decision to perform cesarean section and the delivery was significantly higher than the recommended 30 min for an emergency case, which also contributed to the low Apgar scores overall.
Go to:
Conclusions
In conclusion, the Apgar scores did not differ significantly whether thiopental or propofol was used as an induction agent in women receiving general anesthetic for an emergency cesarean section. However, there was a higher rate of NICU admission among neonates in the propofol group. Propofol does offer the advantage of a shorter recovery time. In a referral center where cesarean sections under general anesthesia are inevitable whether by design or default, it is important to carefully select the induction agent. Furthermore, skilled personnel are required to attend to neonates delivered by cesarean section under general anesthesia.
作者: 51930573 时间: 2015-6-19 10:01
看到此帖，我只想问下：术后椎管内镇痛该用些什么药？除了局麻药说明书标明了能椎管内使用，其它药都没标明呀；在问个问题，复苏未建立静脉通道的患者，气管内给肾上腺素是否违反说明书？抢救无效时，是否就这点判定医务人员过错？就此案例只能说中国医疗的悲哀，不说了，继续顶着风险干活去！
| 欢迎光临 新青年麻醉论坛 (https://xqnmz.com/) | Powered by Discuz! X3.2 |