Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
"Participants, adverse events during and after gastrointestinal procedures with sedation administered were observed and recorded. No intervention was performed."
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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60 years and older patients
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ASA physical state I -IV
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Patients who are qualified to give written informed consent
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Elective gastrointestinal interventions performed under the care of the anesthesia team (such as gastroscopy, colonoscopy).
Exclusion Criteria:
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ASA IV patients
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Patients using sedative agents / Patients already sedated for other purposes
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Non-consenting patients
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Patients with any upper airway obstructive pathology or a history of difficult airway
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Emergency procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bursa Uludag University | Bursa | Turkey |
Sponsors and Collaborators
- Uludag University
Investigators
- Principal Investigator: suna gören, Uludag University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-16/23