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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06439498
Other study ID # 109-SBKAEK
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date August 1, 2024

Study information

Verified date May 2024
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date August 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over the age of 18 who apply to the endoscopy unit for colonoscopy will be included. Exclusion Criteria: - Patients with cognitive dysfunction for whom consent could not be obtained Patients who cannot walk

Study Design


Locations

Country Name City State
Turkey Ankara University School of Medicine Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Non invasive blood pressure when sitting position Non invasive blood pressure when sitting position during first 3 minutes after sitting
Primary Non invasive blood pressurewhen standing position Non invasive blood pressure when standing position during first 3 minutes after standing
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