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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06044298
Enrollment
1500
Registered
2023-09-21
Start date
2024-01-31
Completion date
2024-09-30
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Sedation Complication

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.

Interventions

OTHERprocedural sedation

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

Sponsors

Uludag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Advers event,frailityfirst dayThe 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

MeasureTime frameDescription
Precedural advers eventFirst dayThe 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 effectsFirst dayInvestigators intend to investigate the effects of monitoring respiratory activity through capnography on the improvement of procedural side effects.
Postprocedural advers eventThird dayIn 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.

Countries

Turkey (Türkiye)

Contacts

Primary Contactseda cansabuncu, doctor
sedacansabuncu@uludag.edu.tr+902242953124
Backup Contactselcan akesen, doctor
selcanakesen@uludag.edu.tr+9002242953274

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026