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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Rhinosinusitis (Diagnosis)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study subjects will be enrolled into one arm.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The physician performing the surgery and assessing the surgical field clarity will be masked as to the value of the blood pressure in the individual patient.

Study Groups

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Controlled hypotension

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

Group Type EXPERIMENTAL

Controlled hypotension

Intervention Type PROCEDURE

Controlled hypotension will be administered according to the clarity of the surgical field.

Interventions

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Controlled hypotension

Controlled hypotension will be administered according to the clarity of the surgical field.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No