Ramalingam Rajendiran, Senthamizhselvan Kuppusamy, Harichandrakumar K T, Mohan Pazhanivel
Department of Medical Gastroenterology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Department of Biostatistics, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Euroasian J Hepatogastroenterol. 2023 Jul-Dec;13(2):55-60. doi: 10.5005/jp-journals-10018-1395.
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.
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.
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 ( = 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 ( = 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 ( = 0.01, 0.01, and 0.04, respectively).
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.
Ramalingam R, Senthamizhselvan K, Harichandrakumar KT, . 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.
非镇静状态下的上消化道内镜检查（UGIE）需要最佳的咽部局部麻醉（TPA），以提高患者耐受性和检查效果。人们尝试了多种额外策略来提高患者耐受性，但成效有限。我们假设，使用格隆溴铵进行术前用药可增强TPA效果，提高非镇静状态下UGIE患者的耐受性和检查效果。
我们在2020年7月至2022年5月期间开展了一项随机、双盲、安慰剂对照试验。连续接受非镇静状态下UGIE检查的患者被随机分配，在TPA前30分钟接受静脉注射格隆溴铵或安慰剂。研究了患者耐受性、内镜医师的舒适度、心肺波动情况、食管插管失败率以及检查不完整率。
380例患者被随机分为两组，每组190例。格隆溴铵组和安慰剂组患者总体满意度的视觉模拟评分（VAS）中位数（四分位间距）分别为8（1）和7（2）（P = 0.04）。格隆溴铵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（四分位间距）分别为8（1.3）和8（1）（P = 0.04）。两组患者的食管插管失败率、检查不完整率、心率波动以及血氧饱和度无差异。然而，在操作开始前1分钟和3分钟时，格隆溴铵组的平均动脉压（MAP）显著更高（分别为P = 0.01、0.01和0.04）。
在非镇静状态下的UGIE中，格隆溴铵术前用药可显著提高患者耐受性和内镜医师的舒适度，且对心肺影响极小。因此，可将其纳入日间非镇静内镜检查实践。试验注册号 - CTRI/2020/07/026786。
Ramalingam R, Senthamizhselvan K, Harichandrakumar KT, 等。格隆溴铵术前用药对非镇静状态下上消化道内镜检查患者耐受性和检查效果的影响：一项随机安慰剂对照试验。《欧亚肝脏胃肠病学杂志》2023；13(2):55 - 60。
