Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation

NCT06044298 | Unknown DMC

• 1 other identifier: 2023-16/23
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation Complication; Frailty

Outcome Measures

Primary Outcomes (1)

• Advers event,fraility

  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)

  first day

Secondary Outcomes (3)

• Precedural advers event

  First day

• Capnography and side effects

  First day

• Postprocedural advers event

  Third day

Study Arms (1)

Gastrointestinal 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.

Other: procedural sedation

Interventions

procedural sedation OTHER

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

Gastrointestinal procedural sedation

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: over 60 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators intend to include in the study patients aged 60 and above who have been evaluated in the pre-anesthesia clinic prior to procedures (such as endoscopy, colonoscopy, ERCP, PEG, EUS, ESD) and have received sedation by an anesthesiologist.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• suna gören

  Uludag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

seda cansabuncu, doctor

CONTACT

+902242953124; sedacansabuncu@uludag.edu.tr

selcan akesen, doctor

CONTACT

+9002242953274; selcanakesen@uludag.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

TU (1)