The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Sponsor
- University Hospital Ostrava
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Surgical field clarity in relation to the value of arterial pressure
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Surgical field clarity in relation to the value of arterial pressure
Time Frame: 13 months
Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995)
Secondary Outcomes
- Blood loss(13 months)
- Postoperative pain(13 months)
- Near infrared spectroscopy (NIRS)(13 months)
- Recovery from anaesthesia duration(13 months)
- Cognitive function(13 months)
- Complications of controlled hypotension(13 months)
- Use of tamponade(13 months)
- Surgical revision(13 months)
- Heart rate(13 months)
- Blood pressure(13 months)
- Depth of anaesthesia(13 months)
- Consumption of hypotensives(13 months)
- Postoperative vomiting(13 months)
- Postoperative nausea(13 months)