Yimcharoen Panot, Fogel Evan L, Kovacs Richard J, Rosenfeld Stephen H, McHenry Lee, Watkins James L, Alazmi Waleed M, Sherman Stuart, Lehman Glen A
Department of Medicine, Division of Gastroenterology and Hepatology, Indiana University School of Medicine, University Medical Center, 550 N. University Blvd., Indianapolis, IN 46202, USA.
Gastrointest Endosc. 2006 Jun;63(7):979-85. doi: 10.1016/j.gie.2006.01.052.
Droperidol is a known effective adjunctive agent for sedation/analgesia during endoscopic procedures, particularly in patients who are difficult to sedate with narcotics and benzodiazepines alone. However, the Food and Drug Administration (FDA) warning about potential droperidol-related fatal cardiac arrhythmias, issued in December 2001, led to concern about its safety in current clinical practice.
In this study, we evaluated the effects of droperidol on the Bazett's corrected QT interval (QTcB) administered to patients undergoing ERCP and frequency of cardiac arrhythmias.
We retrospectively reviewed the medical records of patients who, at our institute, underwent ERCP while under sedation/analgesia and who received droperidol. Our protocol for patients who are considered to be candidates for droperidol use includes obtaining an ECG before and 1 to 3 hours after the procedure.
From April 2002 to October 2004, 6292 ERCPs were performed, of which 3113 patients with normal baseline QTcB (2001 women, 1112 men) received droperidol. Mean dosages were 4.3 mg (range, 1.25-10 mg) in women and 4.5 mg (range, 1.25-13.75 mg) in men. A total of 233 patients (7.48%; 133 women, 100 men) developed QTcB prolongation. Mean increases of the QTcB above the upper limit of normal were 16 milliseconds in women (range, 1-194 milliseconds) and 22 milliseconds in men (range, 1-310 milliseconds). Of these, 15 patients (0.48%; 8 women, 7 men) had marked prolongation of the QTcB (defined QTcB, >500 milliseconds). No serious dysrhythmias occurred.
Droperidol at usual doses during sedation/analgesia may precipitate QTcB prolongation above the normal range. However, no QT-related arrhythmias were noted in this study. Clinically significant cardiac events are probably rare with droperidol, despite documented QTcB effects. Baseline electrocardiogram for excluding patients with prolonged baseline QTcB and 1 to 3 hours afterward monitoring appears adequate when using droperidol. The study is still too small to detect very infrequent arrhythmia events.
氟哌利多是一种已知的在内镜检查过程中有效的镇静/镇痛辅助药物，尤其适用于仅使用麻醉药和苯二氮䓬类药物难以镇静的患者。然而，美国食品药品监督管理局（FDA）在2001年12月发布的关于氟哌利多相关潜在致命性心律失常的警告，引发了对其在当前临床实践中安全性的担忧。
在本研究中，我们评估了氟哌利多对接受内镜逆行胰胆管造影（ERCP）患者的Bazett校正QT间期（QTcB）及心律失常发生频率的影响。
我们回顾性分析了在我院接受ERCP镇静/镇痛且使用氟哌利多患者的病历。我们针对被认为适合使用氟哌利多的患者的方案包括在手术前和手术后1至3小时进行心电图检查。
2002年4月至2004年10月，共进行了6292例ERCP，其中3113例基线QTcB正常的患者（2001例女性，1112例男性）使用了氟哌利多。女性的平均剂量为4.3毫克（范围为1.25 - 10毫克），男性为4.5毫克（范围为1.25 - 13.75毫克）。共有233例患者（7.48%；133例女性，100例男性）出现QTcB延长。女性QTcB超过正常上限的平均增加值为16毫秒（范围为1 - 194毫秒），男性为22毫秒（范围为1 - 310毫秒）。其中，15例患者（0.48%；8例女性，7例男性）出现明显的QTcB延长（定义QTcB >500毫秒）。未发生严重心律失常。
在镇静/镇痛期间使用常规剂量的氟哌利多可能会使QTcB延长至正常范围以上。然而，本研究中未观察到与QT相关的心律失常。尽管有QTcB效应记录，但使用氟哌利多时临床上显著的心脏事件可能很少见。在使用氟哌利多时，通过基线心电图排除基线QTcB延长的患者，并在术后1至3小时进行监测似乎是足够的。本研究规模仍然太小，无法检测到非常罕见的心律失常事件。
