Rajendiran Ramalingam, Kuppusamy Senthamizhselvan, K T Harichandrakumar, Pazhanivel Mohan
{"title":"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。","authors":"Rajendiran Ramalingam, Kuppusamy Senthamizhselvan, K T Harichandrakumar, Pazhanivel Mohan","doi":"10.5005/jp-journals-10018-1395","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and aim: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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 (<i>p</i> = 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 (<i>p</i> = 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 (<i>p</i> = 0.01, 0.01, and 0.04, respectively).</p><p><strong>Conclusion: </strong>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.</p><p><strong>How to cite this article: </strong>Ramalingam R, Senthamizhselvan K, Harichandrakumar KT, <i>et al</i>. 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.</p>","PeriodicalId":516317,"journal":{"name":"Euroasian journal of hepato-gastroenterology","volume":"13 2","pages":"55-60"},"PeriodicalIF":0.0000,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10785133/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of Premedication with Glycopyrrolate on Patient Tolerance and Procedure Outcomes in Patients Undergoing Unsedated Upper Gastrointestinal Endoscopy: A Randomized Placebo-controlled Trial.\",\"authors\":\"Rajendiran Ramalingam, Kuppusamy Senthamizhselvan, K T Harichandrakumar, Pazhanivel Mohan\",\"doi\":\"10.5005/jp-journals-10018-1395\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and aim: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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 (<i>p</i> = 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 (<i>p</i> = 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 (<i>p</i> = 0.01, 0.01, and 0.04, respectively).</p><p><strong>Conclusion: </strong>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.</p><p><strong>How to cite this article: </strong>Ramalingam R, Senthamizhselvan K, Harichandrakumar KT, <i>et al</i>. Effect of Premedication with Glycopyrrolate on Patient Tolerance and Procedure Outcomes in Patients Undergoing Unsedated Upper Gastrointestinal Endoscopy: A Randomized Placebo-controlled Trial. 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Effect of Premedication with Glycopyrrolate on Patient Tolerance and Procedure Outcomes in Patients Undergoing Unsedated Upper Gastrointestinal Endoscopy: A Randomized Placebo-controlled Trial.
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.