Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-30 @ 8:43 PM
Study NCT ID:
NCT03815435
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2019-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
Sponsor:
University Hospital Ostrava
Organization:
Study Overview
Official Title:
The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The work compares the effect of different various values of arterial blood pressure on the clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis.
Detailed Description:
The work compares the effect of different values of arterial pressure on the clarity of the surgical field in pansinus operation in patients with chronic rhinosinusitis. A secondary goal of the study is to compare circulatory parameters, depth of anaesthesia, near-infrared spectroscopy (NIRS) and consumption of hypotensives.
Null hypothesis: There is no difference in the clarity of the surgical field at various levels of the mean arterial pressure.
This study is being realized in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of the University Hospital Ostrava (849/2018). According to the statement of the State Institute for Drug Control of 26th April 2019 (reference number Sukl96964/2019), the trial is not considered a clinical trial of medicinal products.
Study type: Single-blind study (the surgeon does not know the value of the patient's blood pressure) prospective study.
Null hypothesis: There is no difference in the clarity of the surgical field at various levels of the mean arterial pressure.
This study is being realized in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of the University Hospital Ostrava (849/2018). According to the statement of the State Institute for Drug Control of 26th April 2019 (reference number Sukl96964/2019), the trial is not considered a clinical trial of medicinal products.
Study type: Single-blind study (the surgeon does not know the value of the patient's blood pressure) prospective study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: