Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation

Not yet recruiting

• Conditions: Frailty; Sedation Complication
• Interventions: Other: procedural sedation

• Registration Number: NCT06044298
• Lead Sponsor: Uludag University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-21
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07
• Study Start: 2024-01
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastrointestinal procedural sedation	procedural sedation	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 Outcome Measures

Name	Time	Method
Advers event,fraility	first day	The primary aim of the FRAEPS study is to prospectively investigate the incidence of peri-procedural complications in elderly patients undergoing gastrointestinal procedural sedation, as well as the relationship between these complications and the frailty assessed by the FRAIL (Fatigue, Resistance, Ambulation, Illness, Loss of weight) scale. FRAIL Scale is rated from 0-5. (Non frail:0, prefrail:1-2, frail: 3-5)

Secondary Outcome Measures

Name	Time	Method
Precedural advers event	First day	The secondary objectives of the FRAEPS study are to determine risk factors for adverse events, explore the relationship between ASA (American Society of Anesthesiologist) classification and frailty scale.
Capnography and side effects	First day	Investigators intend to investigate the effects of monitoring respiratory activity through capnography on the improvement of procedural side effects.
Postprocedural advers event	Third day	In the early post-procedural period (Day 3), investigators will assess whether the patient has returned to their pre-procedure state, whether they require additional support, and determine rates of readmission.

Trial Locations

Locations (1)

Bursa Uludag University; 🇹🇷 Bursa, Turkey