The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery

University Hospital Ostrava

Status: Completed

Conditions: Chronic Rhinosinusitis (Diagnosis)

Treatments: Procedure: Controlled hypotension

Study type: Interventional

Funder types: Other

Identifiers

NCT03815435

KARIM-01-ENSURGERY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic rhinosinusitis undergoing pansinusoperation
• Age over 18 years
• Concrete surgeon (Petr Matoušek, MD, Ph.D., MBA)
• Concrete anaesthetist (Michal Parma, MD)

Exclusion criteria

• Coagulopathy
• Thrombocytopathies
• Vascular wall disorders
• Thrombophlebitis
• Anticoagulation or anti-aggregation therapy
• History of malignancy
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Controlled hypotension

Experimental group

Description:

Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995).

Treatment:

Procedure: Controlled hypotension