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

Study Overview
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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.

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.

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

Conditions
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Chronic Rhinosinusitis (Diagnosis)

Intervention / Treatment
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* Procedure: Controlled hypotension


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study subjects will be enrolled into one arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Controlled hypotension<br>Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995). | Procedure: Controlled hypotension<br>* Controlled hypotension will be administered according to the clarity of the surgical field.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical field clarity in relation to the value of arterial pressure | Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995) | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure will be measured in the morning before surgery, on arrival at the operating theatre and further 5 minutes after anaesthesia, and every five minutes during the surgery. | 13 months | 
| Heart rate | Heart rate will be measured in the morning before surgery, on arrival at the operating theatre and further 5 minutes after anaesthesia, and every five minutes during the surgery. | 13 months | 
| Depth of anaesthesia | Depth of anaesthesia will be measured using the BIS value every 5 minutes | 13 months | 
| Near infrared spectroscopy (NIRS) | Cerebral perfusion will be measured using the NIRS value every 5 minutes | 13 months | 
| Consumption of hypotensives | Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr | 13 months | 
| Blood loss | Blood loss (ml) during the surgery will be measured | 13 months | 
| Recovery from anaesthesia duration | The interval from the end of surgery to eye opening in minutes will be measured. | 13 months | 
| Postoperative pain | Postoperative pain will be measured using the VAS (Visual Analogue Scale) upon arrival to the recovery room and the standard ward. | 13 months | 
| Cognitive function | The standardised clock-drawing test will be performed at the ward, 2 hours after surgery. | 13 months | 
| Postoperative nausea | The presence of postoperative nausea (YES/NO) will be observed. | 13 months | 
| Postoperative vomiting | The presence of postoperative vomiting (YES/NO) will be observed. | 13 months | 
| Complications of controlled hypotension | The presence of complications of controlled hypotension (stroke, myocardial infarction, kidney injury - YES/NO) will be observed. | 13 months | 
| Use of tamponade | The need to use tamponade due to bleeding (YES/NO) will be observed. | 13 months | 
| Surgical revision | The need for surgical revision due to bleeding (YES/NO) will be observed. | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical field clarity, Endonasal surgery, Intraoperative bleeding