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丙泊酚与咪达唑仑用于内科胸腔镜检查:一项随机非劣效性试验。

Propofol versus midazolam in medical thoracoscopy: a randomized, noninferiority trial.

作者信息

Grendelmeier Peter, Tamm Michael, Jahn Kathleen, Pflimlin Eric, Stolz Daiana

机构信息

Clinic of Pulmonary Medicine and Respiratory Cell Research, University Hospital Basel, Basel, Switzerland.

出版信息

Respiration. 2014;88(2):126-36. doi: 10.1159/000362797. Epub 2014 Jun 21.

DOI:10.1159/000362797
PMID:24968814
Abstract

BACKGROUND

Hypoxemia is a surrogate marker for periprocedural endoscopic complications. There are no data comparing the safety of propofol sedation with another sedative regimen in medical thoracoscopy.

OBJECTIVE

To evaluate whether sedation with propofol is as safe and effective as sedation with midazolam.

METHODS

Ninety consecutive patients undergoing medical thoracoscopy were randomly allocated to receive either intravenous propofol or midazolam. Predefined periprocedural complications included hypoxemia, hypotension, bleeding, need for airway insertion, mechanical ventilation, intensive care unit transfer and death. The primary endpoint was the mean lowest oxygen saturation during the procedure.

RESULTS

Randomized groups had similar demographics (64 ± 16 years, 57% male, 91% American Society of Anesthesiologists class III-IV) and a balanced distribution of procedures. The mean lowest oxygen saturation during the procedure was significantly lower in the propofol group as compared to the midazolam group (93 ± 6 vs. 96 ± 3%, p = 0.007). Patients randomized to propofol showed more episodes of hypoxemia (27 vs. 4%, p = 0.007) and hypotension (82 vs. 40%, p < 0.0001). No procedure had to be aborted. None of the patients required an artificial airway, mechanical ventilation or intensive care unit care, and none died.

CONCLUSIONS

As assessed by the surrogate marker hypoxemia, propofol should not be considered the first choice for sedation in medical thoracoscopy.

摘要

背景

低氧血症是围手术期内镜并发症的替代指标。目前尚无数据比较丙泊酚镇静与其他镇静方案在医学胸腔镜检查中的安全性。

目的

评估丙泊酚镇静与咪达唑仑镇静的安全性和有效性是否相当。

方法

连续90例接受医学胸腔镜检查的患者被随机分配接受静脉注射丙泊酚或咪达唑仑。预先定义的围手术期并发症包括低氧血症、低血压、出血、气道插管需求、机械通气、重症监护病房转运和死亡。主要终点是手术期间的平均最低氧饱和度。

结果

随机分组的患者人口统计学特征相似(64±16岁,男性占57%,91%为美国麻醉医师协会III-IV级),手术分布均衡。与咪达唑仑组相比,丙泊酚组手术期间的平均最低氧饱和度显著降低(93±6%对96±3%,p = 0.007)。随机接受丙泊酚的患者出现更多低氧血症发作(27%对4%,p = 0.007)和低血压发作(82%对40%,p < 0.0001)。没有手术被迫中止。没有患者需要人工气道、机械通气或重症监护病房护理,也没有患者死亡。

结论

以低氧血症这一替代指标评估,丙泊酚不应被视为医学胸腔镜检查镇静的首选药物。

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