NCT06439498

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

January 29, 2025

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 28, 2024

Last Update Submit

January 28, 2025

Conditions

Orthostatic Hypotension

Keywords

orthostatic hypotensioncolonoscopy

Outcome Measures

Primary Outcomes (2)

  • Non invasive blood pressure when sitting position

    Non invasive blood pressure when sitting position

    during first 3 minutes after sitting

  • Non invasive blood pressurewhen standing position

    Non invasive blood pressure when standing position

    during first 3 minutes after standing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients over the age of 18 who apply to the endoscopy unit for colonoscopy will be included.

You may not qualify if:

  • Patients with cognitive dysfunction for whom consent could not be obtained Patients who cannot walk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Gülencan YUMUŞAK ERGİN

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 3, 2024

Study Start

May 1, 2024

Primary Completion

December 1, 2024

Study Completion

May 1, 2025

Last Updated

January 29, 2025

Record last verified: 2024-05

Locations

TU(1)