Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation

Bursa Uludag University

Status: Not yet enrolling

Conditions: Sedation Complication; Frailty

Treatments: Other: procedural sedation

Study type: Observational

Funder types: Other

Identifiers

NCT06044298

2023-16/23

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 60 years and older patients
• ASA physical state I -IV
• Patients who are qualified to give written informed consent
• Elective gastrointestinal interventions performed under the care of the anesthesia team (such as gastroscopy, colonoscopy).

Exclusion criteria

• ASA IV patients
• Patients using sedative agents / Patients already sedated for other purposes
• Non-consenting patients
• Patients with any upper airway obstructive pathology or a history of difficult airway
• Emergency procedures

Trial design

1,500 participants in 1 patient group

Gastrointestinal procedural sedation

Description:

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.

Treatment:

Other: procedural sedation