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门诊诊断性上消化道内镜检查中镇静与不镇静的前瞻性随机对照试验。

A prospective, randomized controlled trial of sedation vs. no sedation in outpatient diagnostic upper gastrointestinal endoscopy.

作者信息

Fisher N C, Bailey S, Gibson J A

机构信息

Dept. of Gastroenterology, Stafford General Infirmary, United Kingdom.

出版信息

Endoscopy. 1998 Jan;30(1):21-4. doi: 10.1055/s-2007-993723.

DOI:10.1055/s-2007-993723
PMID:9548039
Abstract

BACKGROUND AND STUDY AIMS

The majority of gastrointestinal endoscopists in the United Kingdom routinely use intravenous sedation prior to diagnostic upper gastrointestinal endoscopy. We conducted a prospective, randomized controlled clinical trial to help determine whether the use of sedation influences the duration, safety, and tolerance of diagnostic upper gastrointestinal endoscopy.

PATIENTS AND METHODS

Adults referred for outpatient diagnostic upper gastrointestinal endoscopy were invited to participate in the study. Patients with a history of previous upper gastrointestinal endoscopy or dysphagia were excluded. Patients were prospectively randomized to sedation with intravenous midazolam (5 mg for those under 65 years or 3 mg for those aged 65 or more), or no sedation. All patients were given topical oropharyngeal anaesthesia with 100 mg lignocaine spray. Outcome measures included duration of procedure, ease of procedure (as assessed by medical and nursing staff), tolerance of procedure (as assessed by patients), and incidence of complications.

RESULTS

100 patients were randomized to receive sedation or no sedation. The two groups were well matched for age, sex, and number of biopsies taken during the procedure. In the non-sedated group, the duration of endoscopy tended to be reduced and the procedure tended to be easier according to the endoscopists' assessment (neither of these observations was significant). The sedated group reported greater comfort for the procedure (P < 0.001), although both groups tolerated the procedure well, and the majority in both groups preferred to have any future procedure repeated in the same manner. There were no serious adverse events in either group.

CONCLUSIONS

In patients who are willing to contemplate upper gastrointestinal endoscopy without sedation, the avoidance of sedation may lead to faster and easier endoscopies, without any increased risk of procedural difficulties or adverse events.

摘要

背景与研究目的

英国大多数胃肠内镜医师在进行诊断性上消化道内镜检查前常规使用静脉镇静剂。我们开展了一项前瞻性随机对照临床试验,以帮助确定镇静剂的使用是否会影响诊断性上消化道内镜检查的时长、安全性及耐受性。

患者与方法

邀请因门诊诊断性上消化道内镜检查前来就诊的成年人参与研究。排除有既往上消化道内镜检查史或吞咽困难病史的患者。患者被前瞻性随机分为静脉注射咪达唑仑镇静组(65岁及以下患者用5毫克,65岁及以上患者用3毫克)或不使用镇静剂组。所有患者均使用100毫克利多卡因喷雾进行口咽局部麻醉。观察指标包括检查时长、操作难易程度(由医护人员评估)、操作耐受性(由患者评估)及并发症发生率。

结果

100例患者被随机分为接受镇静或不接受镇静两组。两组在年龄、性别及检查过程中活检取材数量方面匹配良好。在内镜医师的评估中,未镇静组的内镜检查时长有缩短趋势,操作也趋于更简便(这两项观察结果均无统计学意义)。镇静组报告称操作过程更舒适(P<0.001),尽管两组对操作的耐受性都良好,且两组中的大多数人都希望未来以相同方式重复进行任何检查。两组均未发生严重不良事件。

结论

对于愿意考虑不使用镇静剂进行上消化道内镜检查的患者,避免使用镇静剂可能会使内镜检查更快、更简便,且不会增加操作困难或不良事件的风险。

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