Sedation ComplicationNCT06044298
Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation
An observational study of Sedation Complication and Frailty, run by Uludag University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sedation Complication, Frailty
- What is being tested?
- procedural sedation
- How many people
- 1,500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2024to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Frailty on Adverse Events in Patients Undergoing Gastrointestinal Procedural Sedation: a Multicentre, Prospective, Observational Study(FRAEPS Study)
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
- Being tested
- procedural sedation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procedural sedationOther
"Participants, adverse events during and after gastrointestinal procedures with sedation administered were observed and recorded. No intervention was performed."
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: procedural sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: first day
Secondary outcomes (3)
Precedural advers event
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.
Measured: First day
Capnography and side effects
Investigators intend to investigate the effects of monitoring respiratory activity through capnography on the improvement of procedural side effects.
Measured: First day
Postprocedural advers event
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.
Measured: Third day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study startJan 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansabuncu, Uludag University
- Investigators
- suna gören, Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044298
- Sponsor's protocol ID
- 2023-16/23
- Status last verified
- Dec 2023
- First submitted
- 22 Aug 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Frailty on Adverse Events in Patients Undergoing Gastrointestinal Procedural Sedation: a Multicentre, Prospective, Observational Study(FRAEPS Study)
- ClinicalTrials.gov ID
- NCT06044298
- Acronym / sponsor ID
- 2023-16/23
- Conditions
- Sedation Complication, Frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastrointestinal procedural sedation | – | Other: procedural sedationInvestigators 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| procedural sedation"Participants, adverse events during and after gastrointestinal procedures with sedation administered were observed and recorded. No intervention was performed." | Other | Gastrointestinal procedural sedation |
Primary outcome
Advers event,fraility
Time frame: 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)
3 secondary outcomes
Precedural advers event
Time frame: First day
Capnography and side effects
Time frame: First day
Postprocedural advers event
Time frame: Third day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
suna gören principal investigator
Uludag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation Complication and Frailty, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact seda cansabuncu, doctor (+902242953124, sedacansabuncu@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advers event,fraility (time frame: first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.