Proctor D D, Price J, Minhas B S, Gumber S C, Christie E M
The Department of Medicine, East Carolina University School of Medicine, and Pitt County Memorial Hospital, Greenville, North Carolina 27834-4354, USA.
Am J Gastroenterol. 1999 Apr;94(4):967-71. doi: 10.1111/j.1572-0241.1999.997_s.x.
Although informed consent is an issue in many medical malpractice claims, there is no standardized time or method to obtain informed consent for endoscopic procedures. The objectives of this study were to determine whether sedation for endoscopic procedures interfered with pre-endoscopic informed consent and to determine the appropriate time to obtain informed consent.
Patients undergoing a sedated esophagogastroduodenoscopy had informed consent obtained either 48-72 h before the procedure (group 1A, n = 50) or 10-60 min before the procedure (group 1B, n = 50). Patients undergoing an unsedated flexible sigmoidoscopy had informed consent obtained either 48-72 h before (group 2A, n = 47) or 10-60 min before the procedure (group 2B, n = 49). Methods of informed consent consisted of an oral and a written explanation about the procedure. Patients were sedated with midazolam and meperidine. A Trieger test evaluated recovery from sedation. Recall was assessed by asking six questions about the procedure before discharge and again 2-3 days later.
Standard t tests and Mann-Whitney U nonparametric rank tests were used to compare the 1) 1-h recall scores, 2) 2-3-day recall scores, and 3) recall difference scores for groups 1A and 1B, 1A and 2A, 2A and 2B, and 1B and 2B. There were no differences in recall for the different groups.
This study shows that sedation for endoscopic procedures does not interfere with pre-endoscopic informed consent. Informed consent for endoscopic procedures can be obtained at any time before sedation with similar recall.
尽管知情同意是许多医疗事故索赔中的一个问题，但对于内镜检查程序，尚无标准化的获取知情同意的时间或方法。本研究的目的是确定内镜检查程序中的镇静是否会干扰内镜检查前的知情同意，并确定获取知情同意的合适时间。
接受镇静食管胃十二指肠镜检查的患者在检查前48 - 72小时（1A组，n = 50）或检查前10 - 60分钟（1B组，n = 50）获得知情同意。接受非镇静乙状结肠镜检查的患者在检查前48 - 72小时（2A组，n = 47）或检查前10 - 60分钟（2B组，n = 49）获得知情同意。知情同意的方法包括对该程序进行口头和书面解释。患者使用咪达唑仑和哌替啶进行镇静。通过Trieger测试评估镇静后的恢复情况。通过在出院前询问六个关于该程序的问题以及在2 - 3天后再次询问来评估记忆情况。
使用标准t检验和曼 - 惠特尼U非参数秩检验来比较1）1小时记忆分数、2）2 - 3天记忆分数以及3）1A组和1B组、1A组和2A组、2A组和2B组以及1B组和2B组的记忆差异分数。不同组之间的记忆没有差异。
本研究表明，内镜检查程序中的镇静不会干扰内镜检查前的知情同意。在内镜检查程序的镇静前任何时间获得知情同意，记忆情况相似。
