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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Controlled hypotension will be administered according to the clarity of the surgical field.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
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)
Time frame: 13 months
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.
Time frame: 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.
Time frame: 13 months
Depth of anaesthesia
Depth of anaesthesia will be measured using the BIS value every 5 minutes
Time frame: 13 months
Near infrared spectroscopy (NIRS)
Cerebral perfusion will be measured using the NIRS value every 5 minutes
Time frame: 13 months
Consumption of hypotensives
Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr
Time frame: 13 months
Blood loss
Blood loss (ml) during the surgery will be measured
Time frame: 13 months
Recovery from anaesthesia duration
The interval from the end of surgery to eye opening in minutes will be measured.
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Time frame: 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.
Time frame: 13 months
Cognitive function
The standardised clock-drawing test will be performed at the ward, 2 hours after surgery.
Time frame: 13 months
Postoperative nausea
The presence of postoperative nausea (YES/NO) will be observed.
Time frame: 13 months
Postoperative vomiting
The presence of postoperative vomiting (YES/NO) will be observed.
Time frame: 13 months
Complications of controlled hypotension
The presence of complications of controlled hypotension (stroke, myocardial infarction, kidney injury - YES/NO) will be observed.
Time frame: 13 months
Use of tamponade
The need to use tamponade due to bleeding (YES/NO) will be observed.
Time frame: 13 months
Surgical revision
The need for surgical revision due to bleeding (YES/NO) will be observed.
Time frame: 13 months