Safety of sedation during gastroscopy and colonoscopy in low-risk patients - results of a retrospective subgroup analysis of a registry study including over 170 000 endoscopies

Abstract

Administering sedation is an established standard in gastrointestinal endoscopy, particularly in situations in which sedation is used to make the examination more comfortable for the patient (e. g., during preventive check-up examinations). It is important to have precise information about the risk of sedation-associated complications. The aim of this study was to record the incidence and type of sedation-associated complications in a low-risk group of patients (ASA 1 or 2) undergoing elective diagnostic esophagogastroduodenoscopy or colonoscopy. Risk factors for the development of a sedation complication were also to be identified. Using a prospective multicenter study design, sedation-associated complications were documented in the ProSed2 study using an electronic endoscopy documentation system. Thirty-nine research centers took part inthe study from December 2011 to June 2014. Atotal of 368 206 endoscopies were recorded. 177 944 of the procedures met the defined criteria for subgroup analysis (endoscopy with sedation, patient in ASA class 1 or 2, esophagogastroduodenoscopy or colonoscopy, no emergency endoscopies, no therapeutic procedures). The patients received propofol alone in 64.4 % of the sedations, or a combination of propofol and midazolam in 22.4 %. Sedation was administered by the endoscopist or endoscopy assistant in 56.5 % of cases, or by a third person in 43.5 % (anesthesist < 0.1 %, intensive-care specialist 5.7 %, nurse-administered propofol sedation 37.8 %). A total of 332 minor complications were documented (0.2 %). No major complications or deaths occurred. The following risk factors were identified for the development of sedation-associated complications: Patients in ASA class 2 and sedation with midazolam in combination with an opiate. These findings on sedation-associated complications show that severe complications and deaths do not occur, and that minor complications occur very rarely. Sedation can therefore be regarded as extremely safe in this group of patients. Even though this analysis did not include therapeutic colonoscopies (e. g. polypectomy), these data should lower the threshold for patients undergoing preventive check-up examinations and it should therefore be offered as a standard.