NCT06044298

Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation

The Impact of Frailty on Adverse Events in Patients Undergoing Gastrointestinal Procedural Sedation: a Multicentre, Prospective, Observational Study(FRAEPS Study)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Uludag University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Investigators will include in our study patients aged 60 and over who have been evaluated in the pre-anesthesia clinic for procedures such as endoscopy, colonoscopy, ERCP, PEG, EUS, and ESD, and who have received sedation by an anesthesiologist. Patients will be assessed for frailty prior to the procedure; during and after the procedure, respiratory monitoring (SpO2, capnography) will be closely observed, and they will be contacted by phone three days later. Primary goal of the study is to prospectively investigate the incidence of peri-procedural complications (desaturation, bradycardia, hypotension, etc.) in elderly patients undergoing gastrointestinal procedural sedation, and to assess its relationship with detected frailty using the FRAIL scale.Secondary goals of the study are to identify risk factors for adverse events, examine the relationship of these factors with 'ASA score - age and frailty scale', and determine their impact on the incidence of adverse events. Additionally, investigators aim to research the effects of capnography-based respiratory monitoring on adverse events.

Conditions

• Sedation Complication
• Frailty

Interventions

Type	Name	Description
OTHER	procedural sedation	"Participants, adverse events during and after gastrointestinal procedures with sedation administered were observed and recorded. No intervention was performed."

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-09-21
• Last updated: 2023-12-07

Locations

1 site across 1 country: Turkey (Türkiye)