Hayashi Tomoyuki, Asahina Yoshiro, Takeda Yasuhito, Miyazawa Masaki, Takatori Hajime, Kido Hidenori, Seishima Jun, Iida Noriho, Kitamura Kazuya, Terashima Takeshi, Miyagi Sakae, Toyama Tadashi, Mizukoshi Eishiro, Yamashita Taro
Department of Gastroenterology, Kanazawa University, Kanazawa, Japan.
Innovative Clinical Research Center, Kanazawa University, Kanazawa, Japan.
Clin Endosc. 2023 Sep;56(5):594-603. doi: 10.5946/ce.2022.182. Epub 2023 Apr 12.
BACKGROUND/AIMS: The necessity for pharyngeal anesthesia during upper gastrointestinal endoscopy is controversial. This study aimed to compare the observation ability with and without pharyngeal anesthesia under midazolam sedation.
This prospective, single-blinded, randomized study included 500 patients who underwent transoral upper gastrointestinal endoscopy under intravenous midazolam sedation. Patients were randomly allocated to pharyngeal anesthesia: PA+ or PA- groups (250 patients/group). The endoscopists obtained 10 images of the oropharynx and hypopharynx. The primary outcome was the non-inferiority of the PA- group in terms of the pharyngeal observation success rate.
The pharyngeal observation success rates in the pharyngeal anesthesia with and without (PA+ and PA-) groups were 84.0% and 72.0%, respectively. The PA- group was inferior (p=0.707, non-inferiority) to the PA+ group in terms of observable parts (8.33 vs. 8.86, p=0.006), time (67.2 vs. 58.2 seconds, p=0.001), and pain (1.21±2.37 vs. 0.68±1.78, p=0.004, 0-10 point visual analog scale). Suitable quality images of the posterior wall of the oropharynx, vocal fold, and pyriform sinus were inferior in the PA- group. Subgroup analysis showed a higher sedation level (Ramsay score ≥5) with almost no differences in the pharyngeal observation success rate between the groups.
Non-pharyngeal anesthesia showed no non-inferiority in pharyngeal observation ability. Pharyngeal anesthesia may improve pharyngeal observation ability in the hypopharynx and reduce pain. However, deeper anesthesia may reduce this difference.
背景/目的：上消化道内镜检查期间咽部麻醉的必要性存在争议。本研究旨在比较咪达唑仑镇静下有无咽部麻醉时的观察能力。
这项前瞻性、单盲、随机研究纳入了500例在静脉注射咪达唑仑镇静下接受经口上消化道内镜检查的患者。患者被随机分为咽部麻醉组：PA+组或PA-组（每组250例患者）。内镜医师获取了10张口咽和下咽的图像。主要结局是PA-组在咽部观察成功率方面的非劣效性。
咽部麻醉组和非咽部麻醉组（PA+组和PA-组）的咽部观察成功率分别为84.0%和72.0%。PA-组在可观察部位（8.33对8.86，p=0.006）、时间（67.2对58.2秒，p=0.001）和疼痛（1.21±2.37对0.68±1.78，p=0.004，0-10分视觉模拟评分）方面低于PA+组（p=0.707，非劣效性）。PA-组口咽后壁、声带和梨状窦的合适质量图像较差。亚组分析显示镇静水平较高（ Ramsay评分≥5）时，两组之间咽部观察成功率几乎没有差异。
非咽部麻醉在咽部观察能力方面未显示非劣效性。咽部麻醉可能会提高下咽的咽部观察能力并减轻疼痛。然而，更深的麻醉可能会减少这种差异。
