Orthostatic HypotensionNCT06439498
Frequency of Orthostatic Hypotension in Patients Who Underwent Colonoscopy
An observational study of Orthostatic Hypotension, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Patients who will undergo colonoscopy accompanied by sedoanalgesia will be admitted at Aksaray Training and Research Hospital Gastroenterology Clinic between May and July 2024. Orthostatic hypotension will be evaluated after patients meet the discharge criteria in the postoperative recovery unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Hypotension
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo colonoscopy accompanied by sedoanalgesia will be admitted at Aksaray Training and Research Hospital Gastroenterology Clinic between May and July 2024.
Who may be able to join
- Patients over the age of 18 who apply to the endoscopy unit for colonoscopy will be included.
Who cannot join
- Patients with cognitive dysfunction for whom consent could not be obtained Patients who cannot walk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency of Orthostatic Hypotension and Affecting Factors in Patients Who Underwent Colonoscopy with Procedural Sedoanalgesia
Patients who will undergo colonoscopy accompanied by sedoanalgesia will be admitted at Aksaray Training and Research Hospital Gastroenterology Clinic between May and July 2024. Orthostatic hypotension will be evaluated after patients meet the discharge criteria in the postoperative recovery unit.
Read the detailed description
Patients over the age of 18 who apply to the endoscopy unit for colonoscopy will be included. Patients who will be excluded from the study; Patients with cognitive dysfunction for whom consent could not be obtained Patients who cannot walk
Routine ASA (American Society of Anesthesiologist) monitoring will be applied when patients are taken to the procedure room. Patients will be monitored for oxygen saturation with an oxygen saturation probe, non-invasive blood pressure monitoring, and heart rate and rhythm monitoring with an electrocardiogram. Patients will be given oxygen support via nasal cannula or mask. Patients will be given maintenance intravenous fluids. Patients will receive moderate to deep sedation/analgesia. At the end of the procedure, patients will be taken to the postoperative recovery unit and monitored. Patients will be evaluated according to the Aldrete score and a discharge decision will be made. When the decision to discharge the patients is made, they will first be seated and vital signs will be monitored when they are first placed in a sitting position and at the 3rd minute in the sitting position. Then, the patients will be stood up and vital signs will be monitored when they first stand up and at the 3rd minute. It will be noted whether patients develop additional symptoms. Patients who do not have symptoms and are decided to be discharged will be taken to a second waiting room and will be monitored under observation for a while.
- Conditions
- Orthostatic Hypotension
- Keywords
- orthostatic hypotension, colonoscopy
- Medical subject headings
- Hypotension, Orthostatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Non invasive blood pressure when sitting position
Non invasive blood pressure when sitting position
Measured: during first 3 minutes after sitting
Non invasive blood pressurewhen standing position
Non invasive blood pressure when standing position
Measured: during first 3 minutes after standing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 May 2024
- Primary completion1 Dec 2024
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülencan Yumuşak Ergin, Ankara University
- Investigators
- Gülencan YUMUŞAK ERGİN, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439498
- Sponsor's protocol ID
- 109-SBKAEK
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Orthostatic Hypotension and Affecting Factors in Patients Who Underwent Colonoscopy with Procedural Sedoanalgesia
- ClinicalTrials.gov ID
- NCT06439498
- Acronym / sponsor ID
- 109-SBKAEK
- Conditions
- Orthostatic Hypotension
- Keywords
- orthostatic hypotension, colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 3 Jun 2024 (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.
Patients who will undergo colonoscopy accompanied by sedoanalgesia will be admitted at Aksaray Training and Research Hospital Gastroenterology Clinic between May and July 2024. Orthostatic hypotension will be evaluated after patients meet the discharge criteria in the postoperative recovery unit.
Detailed description
Patients over the age of 18 who apply to the endoscopy unit for colonoscopy will be included. Patients who will be excluded from the study; Patients with cognitive dysfunction for whom consent could not be obtained Patients who cannot walk
Routine ASA (American Society of Anesthesiologist) monitoring will be applied when patients are taken to the procedure room. Patients will be monitored for oxygen saturation with an oxygen saturation probe, non-invasive blood pressure monitoring, and heart rate and rhythm monitoring with an electrocardiogram. Patients will be given oxygen support via nasal cannula or mask. Patients will be given maintenance intravenous fluids. Patients will receive moderate to deep sedation/analgesia. At the end of the procedure, patients will be taken to the postoperative recovery unit and monitored. Patients will be evaluated according to the Aldrete score and a discharge decision will be made. When the decision to discharge the patients is made, they will first be seated and vital signs will be monitored when they are first placed in a sitting position and at the 3rd minute in the sitting position. Then, the patients will be stood up and vital signs will be monitored when they first stand up and at the 3rd minute. It will be noted whether patients develop additional symptoms. Patients who do not have symptoms and are decided to be discharged will be taken to a second waiting room and will be monitored under observation for a while.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo colonoscopy accompanied by sedoanalgesia will be admitted at Aksaray Training and Research Hospital Gastroenterology Clinic between May and July 2024.
Key inclusion criteria (1 listed)
- Patients over the age of 18 who apply to the endoscopy unit for colonoscopy will be included.
Key exclusion criteria (1 listed)
- Patients with cognitive dysfunction for whom consent could not be obtained Patients who cannot walk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non invasive blood pressure when sitting position
Time frame: during first 3 minutes after sitting
Non invasive blood pressure when sitting position
Non invasive blood pressurewhen standing position
Time frame: during first 3 minutes after standing
Non invasive blood pressure when standing position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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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.
Gülencan YUMUŞAK ERGİN principal investigator
Ankara 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 Orthostatic Hypotension, run by Ankara 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 1 inclusion and 1 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 29 Jan 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non invasive blood pressure when sitting position (time frame: during first 3 minutes after sitting). The study lists 2 primary outcomes in all. 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 29 Jan 2025.