Yoshizawa Takashi, Miwa Hiroto, Kojima Takayo, Kawakubo Yoshiaki, Namihisa Akihiro, Ohtaka Keiichi, Ohkura Ryuichi, Nishira Youko, Toriumi Eiko, Nishira Teruo, Sato Nobuhiro
Department of Gastroenterology and Division of Pharmacy, Juntendo University, School of Medicine, Tokyo, Japan.
Gastrointest Endosc. 2003 Oct;58(4):523-30.
EGD with conscious sedation is a safe procedure, but complications such as hypoxia can occur. The efficacy and safety of low-dose flunitrazepam (0.25 mg) was compared with a standard dose of flunitrazepam (0.5 mg) for moderate sedation during EGD.
In a randomized, double-blind, placebo-controlled trial, 75 outpatients (40 men, 35 women, mean age 45 [11] years) undergoing screening EGD were randomly assigned to one of 3 treatment arms: 0.25 mg of flunitrazepam (F0.25 group), 0.5 mg of flunitrazepam (F0.5 group), or placebo (normal saline solution), each administered intravenously. Patient tolerance was scored by using self-assessment questionnaires with visual analogue scales. Cardiopulmonary complications were assessed by monitoring blood pressure, heart rate, oxygen saturation, and the electrocardiogram during the procedure.
The patient tolerance scores in the F0.25 and F0.5 groups, respectively 2.1 (2.1) and 2.3 (2.5), were significantly lower than that for the placebo group (6.5 [3.0]); there was no significant difference between F0.25 and F0.5. Cardiopulmonary complications in the F0.25 group were significantly lower than in the F0.5 group. Oxygen desaturation (oxygen saturation < 90%) was noted in two of 25 patients in the F0.5 group. Post-procedure drowsiness was observed in two of 24 (8.3%) patients in the F0.25 group and 3 of 21 (14.3%) in the F0.5 group (p = 0.2438).
Patient tolerance of EGD with low-dose flunitrazepam (0.25 mg intravenously) was similar to that with a standard dose (0.5 mg intravenously) and significantly better than in the placebo group. Oxygen desaturation was observed only in the group that received the standard dose, suggesting that sedation with low-dose flunitrazepam is efficacious and safe for EGD.
清醒镇静下的上消化道内镜检查是一种安全的操作，但可能会出现诸如缺氧等并发症。本研究比较了低剂量氟硝西泮（0.25毫克）与标准剂量氟硝西泮（0.5毫克）在胃镜检查中进行中度镇静的疗效和安全性。
在一项随机、双盲、安慰剂对照试验中，75名接受胃镜筛查的门诊患者（40名男性，35名女性，平均年龄45[11]岁）被随机分配到3个治疗组之一：0.25毫克氟硝西泮（F0.25组）、0.5毫克氟硝西泮（F0.5组）或安慰剂（生理盐水溶液），每组均通过静脉给药。使用带有视觉模拟量表的自我评估问卷对患者的耐受性进行评分。在操作过程中，通过监测血压、心率、血氧饱和度和心电图来评估心肺并发症。
F0.25组和F0.5组患者的耐受性评分分别为2.1（2.1）和2.3（2.5），显著低于安慰剂组（6.5[3.0]）；F0.25组和F0.5组之间无显著差异。F0.25组的心肺并发症显著低于F0.5组。F0.5组25名患者中有2名出现氧饱和度下降（血氧饱和度<90%）。F0.25组24名患者中有2名（8.3%）、F0.5组21名患者中有3名（14.3%）在术后出现嗜睡（p=0.2438）。
低剂量氟硝西泮（静脉注射0.25毫克）用于胃镜检查时患者的耐受性与标准剂量（静脉注射0.5毫克）相似，且显著优于安慰剂组。仅在接受标准剂量的组中观察到氧饱和度下降，这表明低剂量氟硝西泮镇静用于胃镜检查是有效且安全的。
