积极的术中信息后的术后结果
2018年6月26日 更新者：Georgios Kotsovolis、424 General Military Hospital
术中积极信息对术后疗效影响的研究
计划进行腹腔镜胆囊切除术的患者将被分配到 3 组。
A组和B组患者会在全身麻醉下听到积极的信息。
C组患者不会听消息。
记录术后疼痛、止痛药用量以及恶心、呕吐和出现躁动发作的频率，并在 3 组之间进行比较。
研究概览
研究类型
介入性
注册 (实际的)
5
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Thessaloniki、希腊、56429
- 424 Army General Hospital Department of Anesthesia
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 腹腔镜胆囊切除术。
- 美国标准协会 1-3
排除标准：
- 听力损失。
- 长期使用影响中枢神经系统的药物（抗抑郁药、抗癫痫药、阿片类药物、苯二氮卓类药物）
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
安慰剂组
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耳机将戴在患者的耳朵上，但不会播放任何消息。
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实验性的：BIS 40-60
术中双频指数 (BIS) 为 40-60 的患者。
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消息“你在手术室里。
一切进展顺利。
当您醒来时，您会非常平静，不会感到疼痛，也不会感到恶心”，当双频指数 (BIS) 为 40-60 时，将通过耳机向患者播放希腊语。
消息“你在手术室里。
一切进展顺利。
当您醒来时，您会非常平静，不会感到疼痛，也不会感到恶心”，当双频指数 (BIS) 为 20-40 时，将通过耳机向患者播放希腊语。
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实验性的：国际清算银行 20-40
术中双频指数 (BIS) 为 20-40 的患者。
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消息“你在手术室里。
一切进展顺利。
当您醒来时，您会非常平静，不会感到疼痛，也不会感到恶心”，当双频指数 (BIS) 为 40-60 时，将通过耳机向患者播放希腊语。
消息“你在手术室里。
一切进展顺利。
当您醒来时，您会非常平静，不会感到疼痛，也不会感到恶心”，当双频指数 (BIS) 为 20-40 时，将通过耳机向患者播放希腊语。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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疼痛强度。
大体时间：从全身麻醉中苏醒后平均 15 分钟内。
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将要求患者通过使用 11 级数字评定量表（0 无疼痛，10 最大可能疼痛）来评估他们的术后疼痛。
将在仰卧位、咳嗽后和从仰卧位变为站立位后评估疼痛。
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从全身麻醉中苏醒后平均 15 分钟内。
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术后对乙酰氨基酚的消耗。
大体时间：全身麻醉苏醒后 24 小时。
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将指示患者根据需要要求镇痛药。
当需要抢救镇痛时，将给予 1000 毫克扑热息痛。
将记录对乙酰氨基酚给药的频率。
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全身麻醉苏醒后 24 小时。
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术后服用曲马多。
大体时间：全身麻醉苏醒后 24 小时。
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如果给予扑热息痛不能缓解术后疼痛，患者仍要求镇痛，则给予曲马多100mg。
将记录曲马多给药的频率。
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全身麻醉苏醒后 24 小时。
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出现激动（是/否）。
大体时间：全身麻醉苏醒后平均 10 分钟内。
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患者的精神状态将使用 7 级 Riker 激越-镇静量表进行评估。
如果患者的得分为 5 分或更高，他将被记录为出现躁动的病例。
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全身麻醉苏醒后平均 10 分钟内。
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术后恶心。
大体时间：全身麻醉苏醒后 24 小时。
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将记录恶心发作的频率。
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全身麻醉苏醒后 24 小时。
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术后呕吐。
大体时间：全身麻醉苏醒后 24 小时。
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将记录呕吐发作的频率。
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全身麻醉苏醒后 24 小时。
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疼痛强度。
大体时间：手术结束后1小时。
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将要求患者通过使用 11 级数字评定量表（0 无疼痛，10 最大可能疼痛）来评估他们的术后疼痛。
将在仰卧位、咳嗽后和从仰卧位变为站立位后评估疼痛。
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手术结束后1小时。
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疼痛强度。
大体时间：手术结束后6小时。
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数字评定量表（0 无疼痛，10 最大可能疼痛）。
将在仰卧位、咳嗽后和从仰卧位变为站立位后评估疼痛。
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手术结束后6小时。
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疼痛强度。
大体时间：手术结束后12小时。
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数字评定量表（0 无疼痛，10 最大可能疼痛）。
将在仰卧位、咳嗽后和从仰卧位变为站立位后评估疼痛。
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手术结束后12小时。
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疼痛强度。
大体时间：手术结束后24小时。
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数字评定量表（0 无疼痛，10 最大可能疼痛）。
将在仰卧位、咳嗽后和从仰卧位变为站立位后评估疼痛。
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手术结束后24小时。
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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明确的记忆。
大体时间：全身麻醉苏醒后 24 小时。
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将要求患者回答修改后的 Brice 问卷，以调查对术中信息或其他事件的明确记忆。
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全身麻醉苏醒后 24 小时。
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Georgios Kotsovolis, Dr、424 Army General Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Del Casale A, Ferracuti S, Rapinesi C, Serata D, Caltagirone SS, Savoja V, Piacentino D, Callovini G, Manfredi G, Sani G, Kotzalidis GD, Girardi P. Pain perception and hypnosis: findings from recent functional neuroimaging studies. Int J Clin Exp Hypn. 2015;63(2):144-70. doi: 10.1080/00207144.2015.1002371.
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- Cheng CM, Huang CL. Processes of conscious and unconscious memory: evidence from current research on dissociation of memories within a test. Am J Psychol. 2011 Winter;124(4):421-40. doi: 10.5406/amerjpsyc.124.4.0421.
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- Deeprose C, Andrade J, Harrison D, Edwards N. Unconscious auditory priming during surgery with propofol and nitrous oxide anaesthesia: a replication. Br J Anaesth. 2005 Jan;94(1):57-62. doi: 10.1093/bja/aeh289. Epub 2004 Oct 14.
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- Ghoneim MM. Drugs and human memory (part 1): Clinical, theoretical, and methodologic issues. Anesthesiology. 2004 Apr;100(4):987-1002. doi: 10.1097/00000542-200404000-00033. No abstract available.
- Ghoneim MM, Block RI. Learning and memory during general anesthesia: an update. Anesthesiology. 1997 Aug;87(2):387-410. doi: 10.1097/00000542-199708000-00027. No abstract available.
- Goldmann L, Shah MV, Hebden MW. Memory of cardiac anaesthesia. Psychological sequelae in cardiac patients of intra-operative suggestion and operating room conversation. Anaesthesia. 1987 Jun;42(6):596-603. doi: 10.1111/j.1365-2044.1987.tb03082.x.
- Hadzidiakos D, Horn N, Degener R, Buchner A, Rehberg B. Analysis of Memory Formation during General Anesthesia (Propofol/Remifentanil) for Elective Surgery Using the Process-dissociation Procedure. Anesthesiology. 2009 Aug;111(2):293-301. doi: 10.1097/ALN.0b013e3181ac4a4b.
- Hughes JA, Sanders LD, Dunne JA, Tarpey J, Vickers MD. Reducing smoking. The effect of suggestion during general anaesthesia on postoperative smoking habits. Anaesthesia. 1994 Feb;49(2):126-8. doi: 10.1111/j.1365-2044.1994.tb03368.x.
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- Jelicic M, Bonke B, Millar K. Effect of different therapeutic suggestions presented during anaesthesia on post-operative course. Eur J Anaesthesiol. 1993 Sep;10(5):343-7.
- Kekecs Z, Nagy T, Varga K. The effectiveness of suggestive techniques in reducing postoperative side effects: a meta-analysis of randomized controlled trials. Anesth Analg. 2014 Dec;119(6):1407-19. doi: 10.1213/ANE.0000000000000466.
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- Kessels RP, Remmerswaal M, Wilson BA. Assessment of nondeclarative learning in severe Alzheimer dementia: the Implicit Memory Test (IMT). Alzheimer Dis Assoc Disord. 2011 Apr-Jun;25(2):179-83. doi: 10.1097/WAD.0b013e318203f3ab.
- Kurata J, Hemmings HC Jr. Memory and awareness in anaesthesia. Br J Anaesth. 2015 Jul;115 Suppl 1(Suppl 1):i1-i3. doi: 10.1093/bja/aev224. No abstract available.
- van der Laan WH, van Leeuwen BL, Sebel PS, Winograd E, Baumann P, Bonke B. Therapeutic suggestion has not effect on postoperative morphine requirements. Anesth Analg. 1996 Jan;82(1):148-52. doi: 10.1097/00000539-199601000-00027.
- Lebovits AH, Twersky R, McEwan B. Intraoperative therapeutic suggestions in day-case surgery: are there benefits for postoperative outcome? Br J Anaesth. 1999 Jun;82(6):861-6. doi: 10.1093/bja/82.6.861.
- Leclerc C, Gerard JL, Bricard H. [Intraoperative memory. A study of its incidence in general anesthesia in 326 patients]. Ann Fr Anesth Reanim. 2001 Aug;20(7):592-9. doi: 10.1016/s0750-7658(01)00446-4. French.
- Lequeux PY, Bejjani G, Sekkat H. Implicit memory during isoflurane anesthesia. Anesthesiology. 2006 Aug;105(2):429; author reply 430. doi: 10.1097/00000542-200608000-00032. No abstract available.
- Lequeux PY, Hecquet F, Bredas P. Does anesthetic regimen influence implicit memory during general anesthesia? Anesth Analg. 2014 Nov;119(5):1174-9. doi: 10.1213/ANE.0000000000000162.
- Liu WH, Standen PJ, Aitkenhead AR. Therapeutic suggestions during general anaesthesia in patients undergoing hysterectomy. Br J Anaesth. 1992 Mar;68(3):277-81. doi: 10.1093/bja/68.3.277.
- Lubke GH, Kerssens C, Phaf H, Sebel PS. Dependence of explicit and implicit memory on hypnotic state in trauma patients. Anesthesiology. 1999 Mar;90(3):670-80. doi: 10.1097/00000542-199903000-00007.
- Lubke GH, Kerssens C, Gershon RY, Sebel PS. Memory formation during general anesthesia for emergency cesarean sections. Anesthesiology. 2000 Apr;92(4):1029-34. doi: 10.1097/00000542-200004000-00020.
- Lubke GH, Sebel PS. Awareness and different forms of memory in trauma anaesthesia. Curr Opin Anaesthesiol. 2000 Apr;13(2):161-5. doi: 10.1097/00001503-200004000-00013.
- Mashour GA, Avidan MS. Intraoperative awareness: controversies and non-controversies. Br J Anaesth. 2015 Jul;115 Suppl 1:i20-i26. doi: 10.1093/bja/aev034. Epub 2015 Mar 3.
- McLintock TT, Aitken H, Downie CF, Kenny GN. Postoperative analgesic requirements in patients exposed to positive intraoperative suggestions. BMJ. 1990 Oct 6;301(6755):788-90. doi: 10.1136/bmj.301.6755.788.
- Millar K. Efficacy of therapeutic suggestions presented during anaesthesia: re-analysis of conflicting results. Br J Anaesth. 1993 Oct;71(4):597-601. doi: 10.1093/bja/71.4.597.
- Munte S, Schmidt M, Meyer M, Nager W, Lullwitz E, Munte TF, Piepenbrock S. Implicit memory for words played during isoflurane- or propofol-based anesthesia: the lexical decision task. Anesthesiology. 2002 Mar;96(3):588-94. doi: 10.1097/00000542-200203000-00013.
- Munte S, Kobbe I, Demertzis A, Lullwitz E, Munte TF, Piepenbrock S, Leuwer M. Increased reading speed for stories presented during general anesthesia. Anesthesiology. 1999 Mar;90(3):662-9. doi: 10.1097/00000542-199903000-00006.
- Munte S, Lullwitz E, Leuwer M, Mitzlaff B, Munte TF, Hussein S, Piepenbrock SA. No implicit memory for stories played during isoflurane/alfentanil/nitrous oxide anesthesia: a reading speed measurement. Anesth Analg. 2000 Mar;90(3):733-8. doi: 10.1097/00000539-200003000-00041.
- Munte S, Munte TF, Mitzlaff B, Walz R, Leuwer M, Piepenbrock S. Postoperative reading speed does not indicate implicit memory in elderly cardiac patients after propofol and remifentanyl anaesthesia. Acta Anaesthesiol Scand. 2001 Jul;45(6):750-5. doi: 10.1034/j.1399-6576.2001.045006750.x.
- Myles PS, Hendrata M, Layher Y, Williams NJ, Hall JL, Moloney JT, Powell J. Double-blind, randomized trial of cessation of smoking after audiotape suggestion during anaesthesia. Br J Anaesth. 1996 May;76(5):694-8. doi: 10.1093/bja/76.5.694.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年3月1日
初级完成 (实际的)
2018年2月1日
研究完成 (实际的)
2018年3月1日
研究注册日期
首次提交
2016年4月29日
首先提交符合 QC 标准的
2016年5月6日
首次发布 (估计)
2016年5月9日
研究记录更新
最后更新发布 (实际的)
2018年6月28日
上次提交的符合 QC 标准的更新
2018年6月26日
最后验证
2018年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.