Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation
NCT ID: NCT06044298
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1500 participants
OBSERVATIONAL
2024-01-31
2024-09-30
Brief Summary
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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
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
procedural sedation
"Participants, adverse events during and after gastrointestinal procedures with sedation administered were observed and recorded. No intervention was performed."
Interventions
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procedural sedation
"Participants, adverse events during and after gastrointestinal procedures with sedation administered were observed and recorded. No intervention was performed."
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Uludag University
OTHER
Responsible Party
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Seda Cansabuncu
Medical Doctor
Principal Investigators
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suna gören
Role: PRINCIPAL_INVESTIGATOR
Uludag University
Locations
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Bursa Uludag University
Bursa, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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2023-16/23
Identifier Type: -
Identifier Source: org_study_id