Sedation-related adverse events in gastrointestinal endoscopy (CH-ESC study): study protocol for a prospective, observational cohort study in a Chinese tertiary hospital.

BACKGROUND

Sedation is commonly employed during gastrointestinal endoscopy (GIE), yet sedation-related adverse events (SRAEs)-particularly cardiopulmonary complications-remain a critical safety concern. While large cohort studies from Western countries have identified key risk factors such as advanced age, obesity, and high ASA classification, data on SRAEs within the Chinese population are scarce. This study aims to assess the prevalence, characteristics, and risk factors associated with SRAEs in a Chinese tertiary hospital setting.

METHODS/

DESIGN

This prospective, observational cohort study is being conducted at the Changhai Digestive Endoscopy Center, one of the largest GIE facilities in China. Between November 2023 and November 2026, we aim to recruit 100,100 patients undergoing sedated GIE. The primary outcome is the incidence of SRAEs during the endoscopy procedure. Comprehensive data on patient demographics (e.g., age, BMI), sedation parameters (e.g., medications used, sedation depth), and endoscopic procedure specifics (e.g., type and duration) will be collected, and these candidate factors will be entered into multivariate logistic regression analysis to identify independent predictors of SRAEs.

DISCUSSION: With the increasing application of sedation during GIE, preventing and managing SRAEs is of paramount importance. The outpatient nature and short duration of these procedures complicate accurate reporting, potentially leading to an underestimation of SRAEs. Beyond established risk factors, this study seeks to explore emerging predictors, including waist-to-hip ratio and frailty assessments. Although this is a single-center study, it represents the first large-scale investigation of SRAEs in China and may contribute to improved risk stratification models and enhanced patient safety protocols.

TRIAL REGISTRATION: Chinese Clinical Trial Register, ChiCTR2300078784. Registered on December 18, 2023.

STUDY STATUS: Recruitment began on December 1, 2023. As of July 31, 2024, 6023 participants have been enrolled. The study team plans to request an extension from the Ethics Committee to continue enrolment until December 31, 2028.