Effect of Premedication with Glycopyrrolate on Patient Tolerance and Procedure Outcomes in Patients Undergoing Unsedated Upper Gastrointestinal Endoscopy: A Randomized Placebo-controlled Trial.

Rajendiran Ramalingam, Kuppusamy Senthamizhselvan, K T Harichandrakumar, Pazhanivel Mohan
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Abstract

Background and aim: An optimal topical pharyngeal anesthesia (TPA) is required for better patient tolerance and procedural outcomes of an unsedated upper gastrointestinal endoscopy (UGIE). Several additional strategies have been tried to improve patient tolerance with limited success. We hypothesized that premedication with glycopyrrolate would enhance TPA and improve patient tolerance and procedural outcomes of an unsedated UGIE.

Materials and methods: We conducted a randomized, double-blind, placebo-controlled trial between July 2020 and May 2022. Consecutive patients undergoing unsedated UGIE were randomly assigned to receive either intravenous glycopyrrolate or a placebo 30 minutes before TPA. Patient tolerance, comfort level for the endoscopist, cardiorespiratory fluctuations, percentage of failed esophageal intubation, and incomplete examination were studied.

Results: 380 patients were randomized to 190 in each arm. The median (IQR) VAS scores for the overall patient satisfaction in the glycopyrrolate and placebo groups were 8 (1) and 7 (2), respectively (p = 0.04). The median (IQR) VAS scores for endoscopist assessment of patient cooperation in the glycopyrrolate and placebo groups were 8 (1.3) and 8 (1), respectively (p = 0.04). There was no difference in the percentage of failed esophageal intubation and incomplete examination, fluctuations in heart rate, and oxygen saturation of the participants. However, the mean arterial pressure (MAP) on-table before the start of the procedure at 1 minute and 3 minutes was significantly higher in the glycopyrrolate group (p = 0.01, 0.01, and 0.04, respectively).

Conclusion: In unsedated UGIE, glycopyrrolate premedication significantly improves the patient tolerance and endoscopist's comfort, with minimal cardiorespiratory effects. Hence, it could be incorporated into day-care unsedated endoscopy practice.Trial registration - CTRI/2020/07/026786.

How to cite this article: Ramalingam R, Senthamizhselvan K, Harichandrakumar KT, et al. Effect of Premedication with Glycopyrrolate on Patient Tolerance and Procedure Outcomes in Patients Undergoing Unsedated Upper Gastrointestinal Endoscopy: A Randomized Placebo-controlled Trial. Euroasian J Hepato-Gastroenterol 2023;13(2):55-60.

Abstract Image

使用甘草酸苷进行预处理对接受非静止上消化道内窥镜检查的患者耐受性和手术结果的影响:随机安慰剂对照试验。
背景和目的:无麻醉上消化道内窥镜检查(UGIE)需要最佳的咽部局部麻醉(TPA),以提高患者的耐受性和手术效果。为了提高患者的耐受性,我们还尝试了其他一些策略,但收效甚微。我们假设使用甘草酸苷进行预处理会增强TPA,并提高患者耐受性和无麻醉上消化道内窥镜检查的手术效果:我们在 2020 年 7 月至 2022 年 5 月期间进行了一项随机、双盲、安慰剂对照试验。接受非静注 UGIE 的连续患者被随机分配到接受 TPA 前 30 分钟静脉注射甘珀酸或安慰剂。研究了患者的耐受性、内镜医师的舒适度、心肺功能波动、食管插管失败的比例以及检查不完全的情况:380名患者被随机分为两组,每组190人。甘珀酸组和安慰剂组患者总体满意度的 VAS 评分中位数(IQR)分别为 8(1)和 7(2)(p = 0.04)。甘草酸苷组和安慰剂组内镜医师对患者配合度评估的 VAS 评分中位数(IQR)分别为 8 (1.3) 和 8 (1)(P = 0.04)。参试者食管插管失败和检查不彻底的比例、心率波动和血氧饱和度均无差异。然而,手术开始前 1 分钟和 3 分钟的台上平均动脉压(MAP)明显高于甘珀酸组(P = 0.01、0.01 和 0.04):结论:在无麻醉的 UGIE 中,甘草酸苷预处理可明显提高患者的耐受性和内镜医师的舒适度,同时对心肺功能的影响极小。因此,可将其纳入日间护理的非定时内镜检查实践中。试验登记 - CTRI/2020/07/026786.如何引用本文:Ramalingam R, Senthamizhselvan K, Harichandrakumar KT, et al:随机安慰剂对照试验。Euroasian J Hepato-Gastroenterol 2023;13(2):55-60.
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